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National Collaborating Centre for Mental Health (UK). Dementia: A NICE-SCIE Guideline on Supporting People With Dementia and Their Carers in Health and Social Care. Leicester (UK): British Psychological Society; 2007. (NICE Clinical Guidelines, No. 42.)

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Dementia: A NICE-SCIE Guideline on Supporting People With Dementia and Their Carers in Health and Social Care.

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7THERAPEUTIC INTERVENTIONS FOR PEOPLE WITH DEMENTIA – COGNITIVE SYMPTOMS AND MAINTENANCE OF FUNCTIONING

7.1. INTRODUCTION

There are a number of possible ways to group and categorise interventions in dementia care, for example, by the type of treatment approach used. In this and the following chapter, the main grouping is by the therapeutic goal, with three major domains highlighted: the maintenance of function, including cognitive functions, the management of behaviours that challenge and the reduction of comorbid emotional disorders. Each of these three areas has the aim of improving the quality of life and well-being of the person with dementia, which may in turn impact on the well-being of those providing care. In this chapter, we look at the evidence for the effectiveness of interventions designed to enhance and increase functioning; in the following chapter, the aim of therapy is to reduce depression or agitation or to modify other distressing symptoms of dementia – although potentially this may also be achieved by improving function in other areas.

This chapter focuses specifically on outcomes for the person with dementia, whilst in Chapter 9 interventions directed at carers, whose experience of the effects of dementia is often equally important, are discussed in detail. However, with regard to the intervention reviewed in this chapter, where relevant effects on carers have been documented, these will be highlighted here.

Cognitive symptoms are, of course, recognised as the core of any definition of dementia, and interventions targeting them have been the subject of much research and interest. However, the link between improving cognitive symptoms and maintaining day-to-day function is also key. In considering the efficacy of interventions in this chapter, it is this broader effect that must be the eventual goal.

This chapter includes discussion of both pharmacological and non-pharmacological approaches. The potential range of non-pharmacological ‘interventions’ in dementia care is vast and would include the day-to-day interactions of carers with the person with dementia, the impact of the physical and social environment and all manner of informal ‘therapies’, ranging from art sessions to contact with animals. Evaluating the effects of such different types of interventions alongside each other is a relatively new endeavour and some caution is required, especially when the double-blind RCT is taken as the gold standard (Woods, 2003). In particular:

  • While the pharmacological intervention can be conveniently packaged and standardised, with a measured dose, non-pharmacological interventions can be more difficult to evaluate. The same label may be used for an intervention in different studies, but it may comprise quite different components. Non-pharmacological interventions have rarely used a standardised treatment manual; any such manual would, in any case, need to take on board the range of individual differences between people with dementia if it were to be seen as a credible approach.
  • Double-blind studies are seldom possible, as the person with dementia or carer will be perfectly aware of which intervention he or she is receiving, although it is feasible to ensure that assessors are unaware of group allocation. While it is sometimes possible to design placebo interventions, assuring that those delivering them do so with the same enthusiasm as for the intervention being evaluated is problematic.

Although some interventions can be offered for a discrete period of time, such as half an hour per day, many others involve intervention at the level of the care setting or in the general approach or interactive style of those providing care. Cluster randomised designs would be appropriate for evaluating interventions at care-setting level, but require considerable resources. Where the intervention is designed to be delivered through carer interaction, a key step is to ensure that any training provided is effective in producing the required type and quality of interactions.

7.2. STRATEGIES FOR PROMOTING INDEPENDENCE

7.2.1. Introduction

Promoting independence is important at all stages of dementia and is used in this guideline to mean facilitating performance of or engagement in as much activity as is reasonable and tolerable for the individual. Though the level of independence will change with the stage of dementia and other illnesses, a balance across personal care and productive, leisure, social and spiritual activities is important for quality of life and well-being.

As function deteriorates, it is not uncommon for people with dementia to withdraw from more complex activity and social environments and for others to want to perform tasks for them. However, the literature suggests that functioning in activities of daily living often deteriorates below what would be expected by the illness alone (Tappen, 1994; Beck et al., 1997). Therefore the person with dementia, care providers, family and friends should consider opportunities to maintain an active life and social roles and to promote independence beginning in the early stages of the condition. When exploring appropriate activities, it is also important to consider the right level of stimulation and challenge for the individual. The complexity of activity and level of engagement will change; however, it should not be assumed that the person with dementia does not retain abilities to perform an activity. Individualised and creative ways need to be explored to maximise the use of an individual’s strengths well into the later stages of dementia. Social networks, voluntary services, communities, and health and social services can play an important role in socially including people and maximising independence at all stages of illness.

7.2.2. Interventions for promoting independence

There is little research from which to draw clear conclusions on specific interventions for promoting independence. The following is, therefore, a summary of good practice. Interventions should be selected and implemented based on the needs and strengths of the individual. It is important to note that any one person may benefit from any combination of strategies listed below. Further information about each of the primary-level studies referenced below can be found in Appendix 15b.

Communication

Communication is at the core of all effective psychological interventions, and communication strategies adapted to the individual’s needs and abilities are the main building blocks to maximising skills and ensuring the least amount of dependency care. People with dementia also need to have their vision and hearing tested and the most appropriate aid available for use when interacting (Oddy, 2003).

Good communication means attending to cues which are often non-verbal and using language and sentence structure that matches the individual’s level of comprehension, sensory abilities and culture (Oddy, 2003). Trying out different phrases and words to find the ones that elicit the best response and adapting tone and rate of speech can make the difference between the person with dementia performing a task with a verbal prompt and the care giver carrying out the task for the person.

As well as using verbal and body language, communication may need to take written or pictorial form (Oddy, 2003), such as memory books. Memory books consist of individualised images and simple statements that the person with dementia and care giver can use to aid the individual’s recall and the quality and frequency of communication (Bourgeois et al., 2001).

Where a person with dementia has a specific communication problem, individualised advice regarding appropriate strategies will be needed from a speech and language therapist.

ADL skill training

Literature and current practice suggest that for people with dementia activities of daily living (ADL) skill training can promote independence in personal care tasks (for example, dressing, feeding and washing) and maximise the use of skills and participation in their own care. The training can also lead to less disruption during ADL performance and reduce carer stress (Tappen, 1994; Beck et al., 1997; Rogers et al., 1999). However, more research is required.

ADL skill training involves assessing people’s abilities, impairments and their task performance to understand the underlying physical, psychosocial and neurological factors (Tappen, 1994; Beck et al., 1997). The intervention may involve analysing the results of the assessment to develop individualised programmes for enabling people to perform as many of their ADL tasks as possible themselves (Tappen, 1994; Beck et al., 1997; Pool, 2002). The programmes include graded assistance, which means the care giver providing the least amount of assistance needed at each step to complete the task. Strategies may include verbal or visual cues, demonstration, physical guidance, partial physical assistance and problem solving (Beck et al., 1997). Professionals trained in assessments and care planning with ADLs can devise ADL skill training programmes for use by carers and/or care staff.

Activity planning

The principles of ADL skill training can be applied across various activities beyond personal care. Identifying the person’s strengths and challenges and his or her level of performance can contribute to plans for establishing a wider range of activities. Care providers and the person with dementia should also consider preferences, interests and life histories in order to create meaningful activity plans (Kolanowski et al., 2005; Pool, 2002). The Pool Activity Level instrument provides guidance on individualising activity plans to maximise a person’s performance in individual- or group-based activities (Pool, 2002). The Enriched Opportunities Programme (Brooker & Woolley, in press) demonstrates what can be achieved in care homes. This involved individualised assessment, working with individuals to identify types of occupation and activity that were most likely to lead to well-being and a programme of activity that was rich, integrated with the local community, flexible and practical. Management and staff training issues also needed to be addressed.

Assistive technology

Assistive technology is a broad term defining ‘any item, piece of equipment, product or system, whether acquired commercially, off the shelf, modified or customised, that is used to increase, maintain or improve functional capabilities of individuals with cognitive, physical or communication disabilities’ (Marshall, 2000). The function of this technology is wide ranging, with many products and systems currently available through commercial suppliers or social services. It is not within the scope of this guideline to evaluate or recommend any one piece of assistive technology, but to consider the technology more broadly as an intervention for people with dementia.

Adaptive aids (including low-level technology) and environmental modifications

Adaptive aids and environmental modifications to promote safety and independence in performing a broad range of ADLs are in common use. Adaptive aids can range from memory aids to bathing equipment and are aimed at minimising the impact of physical, cognitive and sensory deficits. Similarly, low-level technology (for example, lights attached to a movement sensor) is widely used in adaptive aids to minimise risk without the need for action by the user. Low-level technology can stand alone without the need for sophisticated computer and telecommunications systems (Cash, 2003). Environmental modifications can be as simple as visual prompts and signs or as complex as structural changes to the home, such as shower installations. Prior to installing equipment as a permanent or sole option, the person’s underlying impairments should be assessed and consideration given to the effect of any treatment or rehabilitation of underlying physical, cognitive and sensory impairments. The provision of an adaptive aid and low-level technology should consider the person with dementia and carer in his or her own environment and be based on the individual’s need; there should be follow-up to evaluate its utility for meeting that need. Information for the purpose and proper use of adaptive aids should be provided.

Memory aids such as calendars, diaries, schedules of daily routine, memory books or electronic devices are often introduced into the individual’s routine in the earlier stages of dementia (Bourgeois et al., 2003). However, some clinicians find combining memory aids with memory training exercises (such as spaced retrieval or cueing hierarchy) can improve the independent use of the aids and also benefit people into the moderate stages of dementia (Bourgeois et al., 2003). Memory aids need to be introduced in collaboration with the user to find the most appropriate aid for him or her and consideration given to how the user can best utilise the aid. An intervention may not work at first or in isolation, so it is useful to think about the whole person in his or her environment before stopping it. For example, Dooley and Hinojosa (2004) note that combining adaptive aids with carer education and environmental modifications contributed to improved outcomes in independence for people with dementia and reduced stress for their carers.

Telecare

Telecare, the delivery of care from a distance to an older person living at home through computers and telecommunications systems, ‘involves a range of services including virtual visiting, reminder systems, home security, and social alarm systems with the overall aim of avoiding hospitalisation and aiding ageing in place’ (Magnusson et al., 2004). People with dementia may be able to live safely and independently, minimising potential risks (Department of Health, 2005a). A telecare package may involve monitoring activity patterns to detect any changes that may warn of potential health changes or of an event such as a fall (Magnusson et al., 2004). Responsive alarms can detect risks by monitoring motion (for example falls) and the presence of fire and gas and triggering a warning to a response centre or carer (Department of Health, 2005a).

The significant benefit of telecare for a person with dementia is that many devices are passive so the individual does not need to remember where they are or how to use them (Cash, 2003). Telecare is one intervention that can be implemented alongside but not replacing care provision (Department of Health, 2005a). Guidance suggests that benefits can be gained by keeping people with dementia at the centre of the development and application of technology (taking into account ethical considerations) and involving them in a partnership working with services and care providers (Cash, 2003; Magnusson et al., 2004).

Initial findings support the use of assistive technology in aiding people to stay in the community longer, thereby delaying moves to higher dependency care (Cash, 2003), but further research is needed before any firm conclusions can be drawn (Magnusson et al., 2004). The Department of Health has published a few useful guides for establishing telecare in local communities (for example, Department of Health, 2005a).

Exercise/promoting mobility

Although conclusions cannot be drawn from current research on the benefits of a specific exercise programme, it is widely accepted that exercise is important for the health of people with dementia (Oddy, 2003). Many benefits are stated to occur – ranging from improved continence to slowing loss of mobility and improving or slowing loss in strength, balance and endurance levels – with overall improved physical functioning in comparison with people not receiving exercise (Oddy, 2003; Schnelle et al, 2002; Shimada et al., 2003; Worm et al., 2001; Chandler et al., 1998). Exercise is also widely used in preventing falls (see NICE, 2004b).

The literature is wide and varied, with descriptions of both standardised group and individualised exercise programmes, which are widely used in practice. Such programmes may involve walking, gait training, resistance training or strengthening exercises, balance and endurance training (Tappen et al., 2000; Chandler et al., 1998; Shimada et al., 2003; Worm et al., 2001). Some reports recommend the use of walking and conversation simultaneously to improve compliance to the exercise (Tappen et al., 2000). Combining exercise with other interventions, such as continence care (Schnelle et al., 2002) and behavioural management techniques (Teri et al., 2003), is also of interest (see below). Teaching care providers effective strategies to encourage exercise and avoid behavioural problems associated with increased activity may make exercise training most effective (Teri et al., 2003).

Exercise is best implemented with the individual’s abilities in mind, and relevant healthcare professionals should determine risk and devise suitable programmes. Risk should not necessarily represent a barrier to people with dementia receiving opportunities for exercise.

Rehabilitation programmes for people with dementia

The Department of Health and independent bodies report that people with dementia are often excluded from rehabilitation programmes because of the nature of the condition (Department of Health, 2003; The Nuffield Institute, 2002). However, there is evidence that they can benefit equally well from rehabilitation-based services, particularly community services (Department of Health, 2003; Nuffield Institute, 2002). Promoting and maintaining cognitive skills and mobility and independence in wider ADLs is possible (Oddy, 2003; Beck et al., 1997; Tappen, 1994; Bourgeois et al., 2003).

Good quality rehabilitation programmes take into account the whole person at the centre of care in his or her environment and are tailored to the individual’s assessed needs, strengths and limitations. This process is no different for people with dementia, although programmes may need to be adapted to compensate for cognitive, perceptual or mood elements. In addition, tailoring programmes to meet the needs of the individual may require time, adaptive aids, communication strategies and organising staff in a different way (Department of Health, 2003). Many of the interventions described in this chapter can be used in a rehabilitation programme. Care givers and care staff may perceive a greater degree of risk in encouraging greater independence in some areas of the person with dementia’s life. Support in considering the balance of risks and benefits in these instances can be helpful.

Combining interventions

One intervention is often not enough because people with dementia do not only experience cognitive impairment, but often physical, emotional and social concerns as well. There is literature on interventions targeting multiple aspects of the person, his or her carers and environment in order to address the complexity of supporting people with dementia (Dooley & Hinojosa, 2004; Gitlin et al., 2003; Graff et al., 2003; Teri et al., 2003). For example, occupational therapy for people with dementia consists of a combination of environmental modification, adaptive aids, problem-solving strategies, skill training and carer/care provider education and training (Gitlin et al., 2003; Dooley & Hinojosa, 2004; Graff et al., 2003). By combining interventions, care providers and professionals are more likely to succeed in promoting the independence of an individual than with the use of one intervention alone (Gitlin et al., 2003; Graff et al., 2003; Dooley & Hinojosa, 2004). Physical health difficulties may contribute to loss of independence, and it is essential that such difficulties are assessed and treated appropriately. Collaborative working between psychiatry and geriatric medicine as part of a multidisciplinary approach would help to achieve this.

An example of combining interventions for promoting and maintaining independence with toileting

Toileting is often an important issue. All avenues should be assessed and relevant interventions tried before concluding that incontinence is permanent and in need of full care and/or incontinence pads. There are often treatable causes that can be uncovered by medical investigation. Observation of the situation is essential to determine the right strategies to maximise independence in toileting. Specialist advice can also be obtained through nursing services, and many communities have specialist continence advisors. The following strategies may be combined:

  • ADL skill training can be used if the person is having difficulty initiating or performing steps to the task. Understanding the person’s underlying difficulties in cognitive, physical and sensory areas can lead to effective care planning for overcoming these difficulties. The task of toileting should be broken down to find where the person may need intervention, beginning with the least invasive form of intervention first (for example, verbal prompts, gestures and visual cues) and leading to physical guidance. The person may need regular prompting to use the toilet at regular intervals.
  • Communication strategies should be considered to find the best way to prompt the person to use the toilet at regular intervals or at moments when the person indicates need. Familiar phrases or words should be explored or gestures or pictures used.
  • If the individual needs assistance finding the toilet (appropriate signage and visual cues), environmental modifications should be considered. Appropriate adaptive aids should be considered to ensure that the toilet is physically accessible and can be used with ease. Contrasting colours may help the person differentiate the toilet from the wall behind it. A commode placed in a visible location in the person’s room may provide a prompt and reduce physical exertion, particularly at night.
  • Exercise can be used to strengthen legs and arms, and abdominal and pelvic floor muscles to improve control, and may improve endurance and ability getting to and using the toilet.

7.2.3. Qualitative review

Evidence included

Two sources of qualitative evidence on the experiences of people with dementia and their carers of strategies for promoting the independence of people with dementia met the eligibility criteria set by the GDG: a non-experimental study with evidence from professionals, carers and people with learning disabilities and dementia (Stalker et al., 1999) and primary research involving 15 people with dementia and with evidence from professionals, people with dementia and carers (Woolham & Frisby, 2002).

Key findings

An evaluation of a home assistive technology package for people with dementia found that the technology worked on the whole, and that family members and professionals felt it reduced risks and helped to maintain the independence of the person with dementia (Woolham & Frisby, 2002). A study involving people with learning disabilities and dementia, along with their key worker and relatives, that explored how far people with learning disabilities and dementia were involved in making decisions and choices in their own lives found wide variations (Stalker et al., 1999). The findings indicate that staff training and development is needed to ensure that care environments enable people with dementia and learning disabilities to exercise choice and control over their everyday lives, and so maximise their independence.

7.2.4. Evidence summary

Ultimately, promoting independence with someone or for oneself is dependent upon opportunities for doing so. Continual engagement in life’s roles and activities is a means in itself for maintaining independence; however, as dementia progresses, some aspects will inevitably become more difficult. By finding out about the person through spending time with him or her, asking family and friends and conducting holistic assessments and observations to keep information current, services and care providers can continually shape interventions to maximise independence. By including the person with dementia and using information from a variety of sources, staff can devise and use a variety of techniques to promote independence in a meaningful way. Promotion of independence means the involvement of the person in his or her ADLs, communities and care, treating him or her with respect, preserving dignity and looking for the abilities and strengths within the person.

Qualitative evidence on the experience of people with dementia and carers points to the contribution that assistive technology can make by reducing risks and promoting independence. Other qualitative evidence highlights the importance of promoting independence for people with dementia and learning difficulties, who should have the opportunity to exercise choice and control over their everyday lives.

7.3. MAINTENANCE OF COGNITIVE FUNCTION: PSYCHOLOGICAL INTERVENTIONS

7.3.1. Introduction

Rigorous evaluations of non-pharmacological interventions are at an early stage of development, in relation to the maintenance of cognitive function. The creativity and enthusiasm of practitioners in the field has often not been followed up by systematic assessment of outcomes, and so a section such as this, which aims to draw together the evidence base, cannot do justice to the range and diversity of interventions that have been developed.

Three major types of approach with a cognitive focus have been delineated (Clare & Woods, 2004). These are:

  1. Cognitive stimulation, which entails exposure to and engagement with activities and materials involving some degree of cognitive processing, usually within a social context and often group based, with the emphasis on enjoyment of activities.
  2. Cognitive training, which involves specific training exercises geared to specific cognitive functions. It includes practice and repetition, may be computer-assisted and may be individual or group based.
  3. Cognitive rehabilitation, which is always individually tailored, involving working on personal goals, often using external cognitive aids and with some use of learning strategies; it is carefully targeted.

Particularly in relation to cognitive rehabilitation approaches, there is a strong tradition of evaluation through series of single case studies, using experimental designs. Individualised, tailored rehabilitation programmes, targeting the goals selected by the person with dementia and his/her carers, are increasingly being developed and used, and show some promise (Clare & Woods, 2004).

Other approaches in this section include reminiscence work, characterised by use of memory triggers, prompting discussion of remote memories, which may be individual or group based; ‘snoezelen’, which involves stimulation of a number of senses using aromas, hand massage and other tactile stimulation, visual light displays and atmospheric music and sounds; and validation therapy, a group-based approach which encourages communication at an emotional level in a safe, facilitative environment.

Multi-sensory stimulation is most typically used with people with moderate to severe dementia, whereas the other approaches are more appropriate for mild to moderate dementia. Reminiscence work is probably the most commonly used of these approaches in the UK. In its previous manifestation, as ‘reality orientation’, cognitive stimulation was widely used, but concerns arose over its inflexible, insensitive application. Current projects emphasise the importance of a person-centred approach as a basis for any of these interventions.

The main emphasis here is on cognitive change, with reference to ADLs and quality of life as an important context for the clinical significance of any changes in cognition. In Chapter 8, other outcomes are considered for these approaches.

7.3.2. Databases searched and inclusion/exclusion criteria

Information about the databases searched and the inclusion/exclusion criteria used for this section of the guideline can be found in Table 7.

Table 7. Databases searched and inclusion/exclusion criteria.

Table 7

Databases searched and inclusion/exclusion criteria.

7.3.3. Studies considered50

We conducted a new systematic search for RCTs that assessed the efficacy of the specified psychological interventions for people with dementia (see Table 8).

Table 8. Study information table for trials of psychological interventions in people with dementia.

Table 8

Study information table for trials of psychological interventions in people with dementia.

Nineteen trials met the guideline eligibility criteria, providing data on 1,132 participants. Of these, one (MORGAN2000) was unpublished and 18 were published in peer-reviewed journals between 1979 and 2004. In addition, 39 studies were excluded from the analysis (further information about both included and excluded studies can be found in Appendix 15c).

7.3.4. Psychological interventions for the treatment of cognitive symptoms of dementia

Evidence from critical outcomes and overall quality of evidence are presented in Table 9. The full evidence profiles and associated forest plots can be found in Appendix 16 and Appendix 20, respectively. The single study of cognitive rehabilitation (LOEWENSTEIN2004) did not present appropriate data to be included in the table. However, the results do not provide any evidence that cognitive rehabilitation improves cognition, ADLs or quality of life when compared to an active control (mental stimulation).

Table 9. Summary evidence table for trials of psychological interventions versus control in people with dementia – cognitive symptoms.

Table 9

Summary evidence table for trials of psychological interventions versus control in people with dementia – cognitive symptoms.

7.3.5. Combination treatment – cognitive stimulation in combination with acetylcholinesterase inhibitors

Onder and colleagues (2005) evaluated the effects of 6 months of cognitive stimulation, delivered by family carers, on people with mild to moderate Alzheimer’s disease who had been stabilized on donepezil for at least 3 months compared with a control group who received donepezil alone. Of a total of 156 randomised, the mean age was 75.8 years, 72% were women and 137 people completed the trial. With regard to cognitive symptoms, there was a statistically significant advantage to the combined treatment group on the MMSE (SMD = −0.39, 95% CI, −0.73 to −0.05) and ADAS-Cog (SMD = −0.44, 95% CI, −0.77 to −0.10).

Chapman and colleagues (2004) evaluated the effects of cognitive stimulation on people with mild to moderate Alzheimer’s disease receiving donepezil compared with a control group who received donepezil alone. The cognitive-communication stimulation intervention consisted of 8 weekly sessions delivered to groups of six to seven participants by a trainer, followed by monthly contacts with participants on an individual basis. All participants in the study had been on a stable dose of donepezil for at least 3 months. Of a total of 54 randomised participants, the mean age was 76.4 years, 54% were women and 41 completed the trial. With regard to cognitive symptoms, there was a benefit from combined treatment as the donepezil-plus-cognitive-stimulation group maintained their level of performance on the MMSE over 1 year, while the donepezil-only group showed a statistically significant decline from baseline (donepezil plus cognitive stimulation: mean change in MMSE= −1.25, 95% CI, −2.78 to 0.28; control group: mean change in MMSE = −2.14, 95% CI, −4.18 to −0.10).

Bottino and colleagues (2005) evaluated the effects of a 5-month programme of weekly group cognitive rehabilitation sessions on mildly impaired people with probable Alzheimer’s disease receiving rivastigmine compared with a control group who received rivastigmine alone. All participants in the study had been on rivastigmine for at least 2 months. Of a total of 13 randomised participants, the mean age was 73.7 years and 69% were women. All 13 completed the trial. With regard to cognitive symptoms, there was a statistically significant benefit from combined treatment on the MMSE (mean MMSE before treatment: combined treatment group = 23.50, SD 3.27; control group = 21.29, SD 3.82, no statistical difference; mean MMSE after treatment: combined treatment group = 24.33, SD 3.14; control group = 19.86, SD 3.67, statistically significant, p = 0.047).

Cahn-Weiner and colleagues (2003) evaluated the efficacy of six group sessions of memory training (cognitive training) delivered by an instructor over a period of 6 weeks on people with probable Alzheimer’s disease, compared with a control group that attended 6 weekly sessions where educational information pertaining to aging and dementia was presented. All participants were taking an acetylcholinesterase inhibitor (donepezil). Of a total of 34 randomised participants, the mean age was 76.9 years, 59% were women and 29 people completed the trial. No significant effects of the intervention were detected on any of the outcome measures of cognitive function.

7.3.6. Health economics evidence

One economic study was identified that assessed the cost-effectiveness of cognitive stimulation therapy (CST) (Knapp et al., 2006). This was a UK study that compared CST to standard care for people with mild to moderate dementia. The objective of the study was to investigate the resource implications and cost-effectiveness of CST in care homes and day centres. The economic analysis was conducted alongside an RCT (Spector et al., 2003).

The study adopted the perspective of the health and personal social services. Costs consisted of those associated with providing the CST intervention, including staff time, travel and equipment, as well as residential care and domestic housing costs, community services costs, and direct medical costs. Clinical outcomes corresponded to those of the study by Spector and colleagues. The primary outcome measure of the analysis was cognition as measured by the MMSE; quality of life, as measured by the QoL-AD, was a secondary outcome measure. The time horizon of the analysis was 8 weeks, which is considered a limitation of the study but corresponded with the length of the CST programme.

The mean weekly cost per person in the CST group was £45.18 higher compared with the respective cost per person in the control group. The difference was statistically significant (p = 0.037). However, there was a difference of £28.53 at baseline weekly cost per person between the two groups (with the CST group being more expensive), as measured over 8 weeks before the intervention started. An analysis of covariance (ANCOVA), carried out to adjust for the baseline cost difference between the groups, reduced the significance of the follow-up difference in costs between groups (p = 0.076). Regarding clinical outcomes, there was a significant improvement for people in the CST group relative to controls on both the MMSE and the QoL-AD. The incremental cost-effectiveness ratio (ICER) for the cognition outcome was £75.32 per additional point on the MMSE, calculated using a mean cost difference of £45.18 and mean outcome difference of 0.6 in favour of CST. For the quality of life outcome, the ICER was £22.82 per additional point of QoL-AD, based on the same mean cost difference and a mean outcome difference of 1.98 in favour of CST.

Further analysis was carried out investigating the impact of group size on the cost-effectiveness of CST. Reducing the average group size from five to three people per group increased the ICER to £102.00 per additional MMSE point, and increasing the group size to seven people caused the ICER to decrease to £63.87 per additional MMSE point. The impact of group size on QoL-AD followed a similar pattern. It must be noted that the changes in the ICERs following an increase or reduction in group size were caused by changes in mean weekly costs per person in the CST group exclusively, as effectiveness results were assumed to remain the same regardless of the group size. However, this may not be true, as clinical outcomes may differ when smaller or larger groups receive the intervention. Subgroup analysis found no difference in results between care homes and day centres. Details of the study are provided in the form of evidence tables in Appendix 18.

The evidence suggests that, in the UK, providing cognitive stimulation therapy alongside usual care for people with mild to moderate dementia in both care homes and day-care centres is likely to be more cost effective than usual care alone.

7.3.7. Qualitative review

Evidence included

Four sources of qualitative evidence on experiences of people with dementia and their carers of psychosocial interventions for the maintenance of cognitive function met the eligibility criteria set by the GDG: primary research involving six people with dementia, three carers and three care staff (Alm et al., 2004); a systematic review (Bates et al., 2004); a case study with evidence from one person with early dementia and a carer (Clare et al., 2003); and primary research with evidence from people with dementia and carers (Spector et al., 1999).

Key findings

Qualitative evidence on the experiences of people with dementia and their carers supports the potential value of a range of psychosocial approaches aimed at maintaining cognitive function. An evaluation of a therapeutic programme for people with dementia involving 12 people with dementia (six receiving standard care and six receiving the intervention) indicates that therapy resulted in a positive effect on friendship (Spector et al., 1999). Spector and colleagues also report that therapy participants reported enjoying the sessions and wishing that they could continue. Quantitative findings indicate that therapy improved cognition and reduced depression and anxiety in people with dementia and also resulted in improvements in carers’ self-rated health status.

Findings from a pilot study of a project to develop a cognitive and communication aid for people with dementia indicate that prompts and stimulation from a computer may assist in reminiscence conversations (Alm et al., 2004). People with dementia could enjoy reminiscence when stimulated by a multi-media reminiscence package; they had no difficulty touching the screen and the package maintained their interest –in particular, they liked local and personal pictures.

A single case study of a person with early dementia’s experience of cognitive rehabilitation suggests that it can help people with dementia to make use of their remaining memory (Clare et al., 2003). This case study points to further beneficial effects of cognitive rehabilitation for people with early Alzheimer’s disease as the intervention was also reported to lift the person with dementia’s distress and did not cause depression.

Finally, according to a systematic review of psychosocial interventions for people with milder dementia (including evidence from professionals, people with dementia and carers) cognitive stimulation (reality orientation) appears efficacious for people with mild dementia, but the value of other interventions is less clear (Bates et al., 2004).

7.3.8. Evidence summary

There is now reasonable evidence to support the use of cognitive stimulation approaches with people with mild to moderate dementia. Importantly, there are now indications of improvements in quality of life to accompany the well-established (modest) improvements in cognitive function. The importance of appropriate, respectful, person-centred carer attitudes in the implementation of these approaches has been highlighted in the largest, and most successful, trial to date.

Cognitive stimulation appears to add to the effects of donepezil in both mild and moderate Alzheimer’s disease.

Cognitive training has generally not been associated with benefits beyond the particular tasks trained. There is insufficient evidence to evaluate fully the effects of reminiscence therapy and cognitive rehabilitation in relation to cognitive function in dementia.

7.4. ACETYLCHOLINESTERASE INHIBITORS OR MEMANTINE FOR THE TREATMENT OF COGNITIVE SYMPTOMS OF NON-ALZHEIMER DEMENTIA

7.4.1. Introduction

Acetylcholinesterase inhibitors (donepezil, galantamine, rivastigmine) are licensed in the UK for the symptomatic treatment of mild to moderately severe Alzheimer’s disease. Memantine was originally licensed for moderately severe to severe Alzheimer’s disease, but the licence was extended in November 2005 and now covers moderate to severe Alzheimer’s disease. Donepezil is a reversible inhibitor of acetyl-cholinesterase, galantamine is a reversible inhibitor of acetylcholinesterase and also has nicotinic receptor agonist properties, and rivastigmine is a reversible non-competitive inhibitor of acetylcholinesterases and also inhibits butyrylcholinesterase. Memantine is an N-methyl-D-aspartate (NMDA)-receptor antagonist that affects glutamate transmission.

Apart from rivastigmine, no drugs are currently licensed for the symptomatic treatment of people with VaD, DLB, FTD or other dementias (subcortical or mixed dementias), although people with these forms of dementia suffer similar problems associated with cognitive symptoms and loss of daily living skills. Rivastigmine is licensed for the symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson’s disease.

If the underlying neurochemical deficit is similar, irrespective of the aetiology of the cognitive impairment, then it is possible that acetylcholinesterase inhibitors or memantine would produce a similar symptomatic effect in other types of dementia. It is therefore important to establish as far as possible from the evidence available whether there is a significant clinical improvement to be gained by treatment with acetylcholinesterase inhibitors or memantine in the other forms of dementia.

The clinical and cost-effectiveness of donepezil, galantamine and rivastigmine for mild to moderately severe AD, and memantine for moderately severe to severe AD are the subject of a NICE technology appraisal51 and so will not be reviewed here. The clinical and cost-effectiveness of donepezil, galantamine, rivastigmine, and memantine for PDD are covered in another NICE guideline52 and so will not be reviewed here.

Current practice

Acetylcholinesterase inhibitors and memantine are currently prescribed in dementia, other than Alzheimer’s type, as part of a clinical trial or at clinical discretion without licence.

The evidence base/limitations

There are no studies of the use of acetylcholinesterase inhibitors or memantine for the treatment of FTD. A treatment response in VaD is difficult to measure because there is no linear progression of deterioration and a longer period of follow-up is probably required to differentiate between treatment and placebo groups. The scales used in the studies considered were devised for use in Alzheimer’s type dementia and there are subtle differences in the nature of the deficits in the two conditions. Studies of MCI are included in this section because of the relatively high rate of progression from the amnestic form of MCI to dementia.

7.4.2. Databases searched and inclusion/exclusion criteria

Information about the databases searched and the inclusion/exclusion criteria used for this section of the guideline can be found in Table 10.

Table 10. Databases searched and inclusion/exclusion criteria.

Table 10

Databases searched and inclusion/exclusion criteria.

7.4.3. Studies considered53

We conducted a new systematic search for studies that assessed the efficacy and/or safety of donepezil, galantamine, rivastigmine (acetylcholinesterase inhibitors) or memantine (NMDA-receptor antagonist) (see Table 11).

Table 11. Study information table for trials of acetylcholinesterase inhibitors or memantine versus placebo in people with non-Alzheimer dementia.

Table 11

Study information table for trials of acetylcholinesterase inhibitors or memantine versus placebo in people with non-Alzheimer dementia.

Ten trials met the guideline eligibility criteria, providing data on 5,894 participants. Of these, two were unpublished and eight were published in peer-reviewed journals between 2000 and 2005. In addition, 22 studies were excluded from the analysis (further information about both included and excluded studies can be found in Appendix 15d).

7.4.4. Acetylcholinesterase inhibitors or memantine for the treatment of cognitive symptoms of non-Alzheimer dementia or mild cognitive impairment

Evidence from critical outcomes and overall quality of evidence are presented in Table 12. The full evidence profiles and associated forest plots can be found in Appendix 16 and Appendix 20, respectively.

Table 12. Summary evidence table for trials of acetylcholinesterase inhibitors or memantine versus placebo in people with non-Alzheimer dementia or MCI – cognitive symptoms.

Table 12

Summary evidence table for trials of acetylcholinesterase inhibitors or memantine versus placebo in people with non-Alzheimer dementia or MCI – cognitive symptoms.

7.4.5. Qualitative review

Evidence included

No sources of evidence were found that met the eligibility criteria set by the GDG relating specifically to the experience of treatment of non-Alzheimer dementia with acetylcholinesterase inhibitors or memantine. Qualitative evidence on the experiences of people with dementia and their carers of the use of medication for dementia was identified, but as this may include evidence from people with Alzheimer’s disease it is discussed elsewhere (see Section 7.7).

7.4.6. Evidence summary

In people with VaD, acetylcholinesterase inhibitors (donepezil 5 or 10 mg/day, galantamine 24 mg/day for 24 weeks) when compared to placebo in three trials produced a small treatment effect on cognition (on average, about two points on the ADAS-Cog), which was not shown to have any clinically significant benefit to the person with dementia (in terms of global functioning or ADLs). Evidence suggested an increased risk of adverse events, particularly anorexia and cramps (although serious adverse events are unlikely). The evidence suggests that at high doses the potential benefits are unlikely to outweigh the increased risk of adverse events. When given at lower doses, adverse events are less likely; therapeutic responses are not diminished, but are still unlikely to outweigh the potential increased risk of adverse events.

In two trials of memantine (10 mg/day for 28 weeks) in people with VaD, although the overall risk of adverse events was relatively low, there was an increased risk of constipation and any clinical improvement was very limited (on average, less than two points on the ADAS-Cog). As with donepezil and galantamine, there was no clinically significant benefit to the person with dementia (in terms of global functioning or ADL). Therefore, any potential benefits are unlikely to outweigh the potential increased risk of adverse events.

In people with DLB, there was one trial of rivastigmine (up to 12 mg/day for 20 weeks) versus placebo. The primary outcome measures in this study were a computerised cognitive assessment and a measure of psychotic symptoms derived from a four-item subscore of the neuropsychiatric inventory (NPI). Evidence from the latter will be discussed in Chapter 8. Results from the cognitive test suggest that rivastigmine may produce benefits in terms of ADLs. Secondary outcomes point to benefits in cognitive symptoms and global functioning, but the study’s relatively small sample size limits the conclusions that can be drawn. Adverse events were described as mild to moderate and were mainly cholinergic in nature (for example, nausea). The evidence suggests that an increased risk of serious adverse events is unlikely. Therefore, there is currently insufficient evidence to determine whether the potential benefits with regard to cognitive symptoms outweigh the potential risks.

In people with MCI, two trials of donepezil (10 mg/day for 24 weeks or 156 weeks) and two trials of galantamine (16 mg/day for 104 weeks) were considered. Although in the first 12 months of treatment with donepezil there was a significant reduction in the number of cases converting to dementia, this was not sustained over 36 months. Evidence suggests an increased risk of adverse events and in the two trials of galantamine there was an, as yet unexplained, increase in the risk of mortality. Therefore, for both these drugs the potential benefits are unlikely to outweigh the increased risks of adverse events.

7.5. MEDICINES OTHER THAN ACETYLCHOLINESTERASE INHIBITORS/MEMANTINE FOR THE TREATMENT OF COGNITIVE SYMPTOMS OF DEMENTIA

7.5.1. Introduction

Apart from acetylcholinesterase inhibitors and memantine, a number of other putative compounds or popular remedy preparations have been suggested or investigated. In addition, the potential for developing compounds that modify the disease process in the dementias is exciting, as our knowledge of the underlying pathological changes is growing dramatically.

Acetylcholinesterase inhibitors increase the availability of acetylcholine in the synapse. An alternative approach utilising the same system would be to increase the efficiency of the post-synaptic cholinergic receptors, both muscarinic and nicotinic, by the use of agonists or modulators (for a recent review, see Standridge, 2005). No satisfactory compound has, as yet, been discovered that combines adequate clinical efficacy together with acceptable tolerability.

Ginkgo biloba is a widely available and popular preparation sold in Europe and elsewhere for ‘cerebral insufficiency’. There are many different agents in the extract, produced from the maidenhair tree, and the potential mechanisms of action include vasoactive effects, antiplatelet activity, increasing neurone tolerance to anoxia and prevention of membrane damage caused by free radicals.

Antioxidants, such as vitamin E, have the theoretical potential to reduce concentrations of free radicals, which appear to be involved in the process of neurodegeneration seen in all the dementias.

Anti-inflammatory agents might appear potentially useful because an inflammatory and immunological response has been shown to contribute to the formation of neuritic plaques and neurofibrillary tangles, but these compounds have significant adverse effects, particularly in elderly populations.

The evidence for older compounds currently available in the UK or Europe, like hydergine, piracetam and naftidrofuryl, will also be included in the review if relevant studies are found.

Current practice

Those products that are available to purchase over the counter or via the internet are taken at the discretion of the individual, who may also seek professional advice. Those preparations currently available on prescription but not licensed for the treatment of dementia should only be prescribed as part of a clinical trial.

7.5.2. Databases searched and inclusion/exclusion criteria

Information about the databases searched and the inclusion/exclusion criteria used for this section of the guideline can be found in Table 13.

Table 13. Databases searched and inclusion/exclusion criteria.

Table 13

Databases searched and inclusion/exclusion criteria.

7.5.3. Studies considered

We conducted a new search for systematic reviews of RCTs that assessed the efficacy and/or safety of medicine other than acetylcholinesterase inhibitors or memantine for the treatment of cognitive symptoms of dementia (Table 14). Where a recent systematic review of adequate quality was found, we searched for more recent RCTs relevant to the review.

Table 14. Study information table for trials of other medicines versus placebo in people with dementia – cognitive symptoms.

Table 14

Study information table for trials of other medicines versus placebo in people with dementia – cognitive symptoms.

Eight systematic reviews and three new trials met the guideline eligibility criteria, providing data on 10,512 participants (further information about the new trials can be found in Appendix 15e).

7.5.4. Other medicines versus placebo for the treatment of cognitive symptoms of dementia

Evidence from critical outcomes and overall quality of evidence are presented in Table 15. The full evidence profiles can be found in Appendix 16.

Table 15. Summary evidence table for other medicines versus placebo in people with dementia – cognitive symptoms.

Table 15

Summary evidence table for other medicines versus placebo in people with dementia – cognitive symptoms.

7.5.5. Qualitative review

Evidence included

We found no sources of evidence that met the eligibility criteria set by the GDG relating specifically to the experience of treatment with other medicines in people with dementia.

7.5.6. Evidence summary

Evidence from systematic reviews of RCTs suggests that for vitamin E (2,000 IU total daily dose divided into two doses for 24 months), nimodipine (90/180 mg/day for 12 to 26 weeks), folic acid (2 to 15 mg/day, for 1 to 3 months) and indomethacin (100 to 150 mg/day for 6 months) the increased risk of adverse events outweighs any potential benefit to people with dementia.

There is currently insufficient evidence from RCTs to determine whether vitamin B12 (10/50/1000 mcg/day for 1 to 5 months), sage (salvia officinalis extract 60 drops/day for 4 months), nicergoline (40 to 60 mg/day for 4 to 104 weeks) and hydergine (1.5 to 7.5 mg/day for 9 to 60 weeks) have benefits that outweigh any risk of adverse events.

One systematic review reported evidence from 33 RCTs of ginkgo biloba (80 to 600 mg/day for 3 to 52 weeks) versus placebo in 3,278 participants with dementia. We also identified one new RCT not included in the systematic review, which included 123 participants randomised to ginkgo (160 to 240 mg/day) or placebo. The evidence suggests that the benefits of ginkgo may outweigh a low risk of adverse events. However, because the meta-analysis was based on a completer analysis and a variety of measures of cognition, it is difficult to determine the clinical importance of the observed effects.

7.6. MEDICINES THAT CONTROL RISK FACTORS FOR VASCULAR DEMENTIA FOR THE TREATMENT OF COGNITIVE SYMPTOMS OF DEMENTIA

7.6.1. Introduction

In VaD, concurrent physical illnesses such as hypertension, diabetes, heart disease and hypercholesterolaemia will be treated with recommended drugs for the management of these problems. It is assumed that the control of the comorbid conditions reduces the risk of further cerebral damage, but there is no assumption that there will be any effect on cognitive function.

7.6.2. Databases searched and inclusion/exclusion criteria

Information about the databases searched and the inclusion/exclusion criteria used for this section of the guideline can be found in Table 16.

Table 16. Databases searched and inclusion/exclusion criteria.

Table 16

Databases searched and inclusion/exclusion criteria.

7.6.3. Studies considered

We conducted a new search for systematic reviews (and more recent RCTs) that assessed the efficacy and/or safety of drugs used to control risk factors for VaD (Table 17 and Table 18), more specifically, drugs for hypertension, drugs that control glucose levels for people with diabetes, antiplatelet treatment, statins and other cholesterol-lowering drugs, and xanthine derivatives.

Table 17. Study information table for trials of drugs that control VaD risk factors versus placebo for the treatment of cognitive symptoms.

Table 17

Study information table for trials of drugs that control VaD risk factors versus placebo for the treatment of cognitive symptoms.

Table 18. Study information table for trials of drugs that control VaD risk factors versus placebo for the treatment of cognitive symptoms.

Table 18

Study information table for trials of drugs that control VaD risk factors versus placebo for the treatment of cognitive symptoms.

Four systematic reviews and one new trial met the guideline eligibility criteria. However, only one review and one trial reported appropriate data on the outcomes of interest.

7.6.4. Drugs that control vascular dementia risk factors versus placebo for the treatment of cognitive symptoms

Evidence from critical outcomes is presented in Table 19.

Table 19. Summary evidence table for trials of drugs that control VaD risk factors versus placebo for the treatment of cognitive symptoms.

Table 19

Summary evidence table for trials of drugs that control VaD risk factors versus placebo for the treatment of cognitive symptoms.

7.6.5. Qualitative review

Evidence included

We found no sources of evidence that met the eligibility criteria set by the GDG relating to the experience of treatment with drugs that control VaD risk factors.

7.6.6. Evidence summary

In the studies reviewed, cognitive symptoms, global functioning and ADLs were not reported as outcome measures of the research, except for propentofylline, but the evidence was of poor quality. There is therefore currently no evidence to suggest that these treatments, for conditions deemed to be vascular risk factors, have any beneficial effect on cognitive symptoms. The quality of the evidence for propentofylline is low and the benefits marginal, so these are unlikely to outweigh the risk of adverse events.

7.7. QUALITATIVE EVIDENCE ON THE EXPERIENCES OF PEOPLE WITH DEMENTIA AND THEIR CARERS OF MEDICATION FOR THE TREATMENT OF DEMENTIA

The evidence reviewed concerning the effectiveness of pharmacological interventions for dementia has primarily been derived from systematic synthesis and meta-analysis of randomised controlled trials. Typically, this approach measures outcomes for people with dementia, and sometimes for their carers, in terms of a range of instruments such as scales or questionnaires from which quantified data can be derived. A limitation of this approach is that in most cases the results contain little reportage of the direct voice of people with dementia and their carers. To complement this analysis, a search was made for qualitative research that reported in their own words the views of people with dementia and their carers on the experience of receiving pharmacological treatment and its outcomes.

7.7.1. Evidence included

Four sources of qualitative evidence on the experiences of people with dementia and their carers of the use of medication for people with dementia met the eligibility criteria set by the GDG: a descriptive account (C1) with evidence from one carer (Anon, 2002), a questionnaire survey (B3) involving 64 carers (Bayer, 1994), case studies (C1) with evidence from people with dementia and carers (Davis & Davis, 2005), and a multi-centre survey (B3) in which 176 people caring for older relatives (including some people with dementia) were interviewed (Smith et al., 2003).

7.7.2. Key findings

Evidence from 64 carers of people with dementia attending a memory clinic who completed questionnaires that explored their views on dementia drugs indicates that carers value them (Bayer, 1994). According to carers’ responses, they feel that benefits from dementia drugs are evident at the earliest stages of dementia and they also think that dementia drugs are needed at very early stages when any improvement in, or stabilisation of, the person with dementia’s condition can be appreciated. Most carers feel that the benefits of medication for dementia should be discernible for about 6 months, and if not it is not worth taking the drug, but those carers less in touch with people with dementia thought the benefits of drugs should last about 1 year.

Another survey of people caring for older relatives explored their attitudes to and experiences of managing medication for them (Smith et al., 2003). While not focussed on dementia care, the survey did include carers of people with dementia and furthermore appears relevant as many carers reported having to remind care recipients and help them with medication. Smith and colleagues interviewed 176 people caring for older relatives and found that they had worries about medication that need to be addressed. The survey suggests that more attention should be given to what is a stressful issue for some carers – this might be achieved if carers’ needs are explored at regular medication reviews and through pharmacists giving information about medication to carers.

Two personal accounts are also relevant. One documenting the physical and mental difficulties and exhaustion experienced by one carer of a person with dementia reports that home helps and respite were much appreciated, and that medication was used to help settle the person with dementia at night (Anon, 2002). A second personal account from a person with dementia and a carer relates experiences of the diagnosis of dementia and of rehabilitation, and reports that medication for the person with dementia was stopped because of side effects (Davis & Davis, 2005). This case study points to a need for the experiences of the person with dementia and carers to be taken into consideration when managing medication.

Alzheimer’s Society survey of people with dementia and carers

An Alzheimer’s Society survey of people’s experiences of dementia medication found that three quarters of respondents – including people with dementia, carers and professionals – were largely positive and felt that dementia medication was to some degree beneficial (Alzheimer’s Society, 2004). This survey did not use qualitative methodology, but is noteworthy as the number of respondents was high (of over 4,000 respondents, 2,889 had experience of at least one medication used for the treatment of dementia) and there is a paucity of other evidence on the experiences of people with dementia and their carers of medication for dementia.

7.7.3. Conclusion

Apart from four publications relating carers’ experiences, which made brief comment on the role of drug treatment, this transpired to be an undeveloped field of research. Given the magnitude of public response to policy changes in relation to the availability of treatment for dementia, the dearth of well-conducted qualitative research would appear to be a potential priority for future funding. Responses to a survey conducted by the Alzheimer’s Society indicate that many people with dementia and many carers experience beneficial effects from drug treatment for dementia using acetyl-cholinesterase inhibitors or memantine.

Evidence on the experiences of people with dementia and carers indicates that, when managing medication, the feelings of the person with dementia and carers should be taken into consideration, including their feelings about whether side effects are tolerable.

7.8. RESEARCH RECOMMENDATIONS

7.8.1. Cognitive stimulation and/or acetylcholinesterase inhibitors in Alzheimer’s disease

For people with AD, are cognitive stimulation (activities involving cognitive processing; usually in a social context and often group-based, with an emphasis on enjoyment of activities), acetylcholinesterase inhibitors (donepezil, galantamine or rivastigmine) or combined treatment clinically and cost effective in terms of cognition, global functioning, ADLs and quality of life when compared with placebo over 6 months?

Why this is important

No randomised studies have directly compared cognitive stimulation with an acetyl-cholinesterase inhibitor, and few randomised studies have compared the combination with an acetylcholinesterase inhibitor alone in people with mild-to-moderate AD. Evidence suggests that cognitive stimulation is effective in people with dementia, but it is difficult to compare the magnitude of the effect with that of acetylcholinesterase inhibitors.

7.9. HEALTH AND SOCIAL CARE RECOMMENDATIONS

7.9.1. Promoting and maintaining independence of people with dementia

7.9.1.1.

Health and social care staff should aim to promote and maintain the independence, including mobility, of people with dementia. Care plans should address ADLs that maximise independent activity, enhance function, adapt and develop skills, and minimise the need for support. When writing care plans, the varying needs of people with different types of dementia should be addressed. Care plans should always include:

  • consistent and stable staffing
  • retaining a familiar environment
  • minimising relocations
  • flexibility to accommodate fluctuating abilities
  • assessment and care-planning advice regarding ADLs, and ADL skill training from an occupational therapist
  • assessment and care-planning advice about independent toileting skills; if incontinence occurs all possible causes should be assessed and relevant treatments tried before concluding that it is permanent
  • environmental modifications to aid independent functioning, including assistive technology, with advice from an occupational therapist and/or clinical psychologist
  • physical exercise, with assessment and advice from a physiotherapist when needed
  • support for people to go at their own pace and participate in activities they enjoy. [For the evidence, see section 7.2]
7.9.1.2.

When developing a care plan for a person with a learning disability newly diagnosed with dementia, an assessment using the AMPS59 should be considered. The DMR60 and BPT61 should be considered for monitoring change in function over time. [For the evidence, see section 4.6.3]

7.9.2. Non-pharmacological interventions for cognitive symptoms and maintaining function

7.9.2.1.

People with mild-to-moderate dementia of all types should be given the opportunity to participate in a structured group cognitive stimulation programme. This should be commissioned and provided by a range of health and social care staff with appropriate training and supervision, and offered irrespective of any drug prescribed for the treatment of cognitive symptoms of dementia. [For the evidence, see section 7.3]

7.9.3. Pharmacological interventions for the cognitive symptoms of Alzheimer’s dementia62

7.9.3.1.

The three acetylcholinesterase inhibitors donepezil, galantamine and rivastigmine63 are recommended as options in the management of people with AD of moderate severity only (that is, those with an MMSE score of between 10 and 20 points), and under the following conditions. [NICE TA 2006]

  • Only specialists in the care of people with dementia (that is, psychiatrists including those specialising in learning disability, neurologists, and physicians specialising in the care of the elderly) should initiate treatment. Carers’ views on the patient’s condition at baseline should be sought.
  • Patients who continue on the drug should be reviewed every 6 months by MMSE score and global, functional and behavioural assessment. Carers’ views on the patient’s condition at follow-up should be sought. The drug should only be continued while the patient’s MMSE score remains at or above 10 points and their global, functional and behavioural condition remains at a level where the drug is considered to be having a worthwhile effect. Any review involving MMSE assessment should be undertaken by an appropriate specialist team, unless there are locally agreed protocols for shared care.
7.9.3.2.

Although it is recommended that acetylcholinesterase inhibitors should be prescribed only to people with AD of moderate severity, healthcare professionals should not rely on the MMSE score in certain circumstances.

These are:

  • in those with an MMSE score greater than 20, who have moderate dementia as judged by significant impairments in functional ability and personal and social function compared with premorbid ability
  • in those with an MMSE score less than 10 because of a low premorbid attainment or ability or linguistic difficulties, who have moderate dementia as judged by an assessment tool sensitive to their level of competence
  • in people with learning disabilities
  • in people who are not fluent in spoken English or in the language in which the MMSE is applied. [For the evidence, see sections 4.6.3 and 6.4.4]
7.9.3.3.

For people with learning disabilities, tools used to assess the severity of dementia should be sensitive to their level of competence. Options include:

7.9.3.4.

When the decision has been made to prescribe an acetylcholinesterase inhibitor, it is recommended that therapy should be initiated with a drug with the lowest acquisition cost (taking into account required daily dose and the price per dose once shared care has started). However, an alternative acetylcholinesterase inhibitor could be prescribed where it is considered appropriate having regard to adverse event profile, expectations around concordance, medical comorbidity, possibility of drug interactions, and dosing profiles. [NICE TA 2006]

7.9.3.5.

Memantine is not recommended as a treatment option for people with moderately severe to severe AD except as part of well-designed clinical studies. [NICE TA 2006]

7.9.3.6.

People with mild Alzheimer’s disease who are currently receiving donepezil, galantamine or rivastigmine, and people with moderately severe to severe Alzheimer’s disease currently receiving memantine, whether as routine therapy or as part of a clinical trial, may be continued on therapy (including after the conclusion of a clinical trial) until they, their carers and/or specialist consider it appropriate to stop. [NICE TA 2006]

7.9.4. Pharmacological interventions for the cognitive symptoms of non-Alzheimer dementias and mild cognitive impairment

7.9.4.1.

For people with vascular dementia, acetylcholinesterase inhibitors and memantine should not be prescribed for the treatment of cognitive decline, except as part of properly constructed clinical studies. [For the evidence, see section 7.4]

7.9.4.2.

For people with MCI, acetylcholinesterase inhibitors should not be prescribed, except as part of properly constructed clinical studies. [For the evidence, see section 7.4]

Footnotes

50

Here, and elsewhere in the guideline, each study considered for review is referred to by a study ID in capital letters (primary author and date of study publication, except where a study is in press or only submitted for publication, then a date is not used).

51

For further information see www​.nice.org.uk/guidance/TA111.

52

For further information see www​.nice.org.uk/guidance/CG35.

53

Here, and elsewhere in the guideline, each study considered for review is referred to by a study ID in capital letters (primary author and date of study publication, except where a study is in press or only submitted for publication, then a date is not used).

55
56
57
58
59

The AMPS should be carried out by someone with formal training in its use.

60
61
62

The GDG has not had any responsibility for the development of the NICE technology appraisal on the clinical and cost effectiveness of donepezil, galantamine and rivastigmine for mild to moderate Alzheimer’s disease and memantine for moderate to severe Alzheimer’s disease (for further information see www​.nice.org.uk). Nevertheless, following NICE protocol, the technology appraisal recommendations have been incorporated verbatim into this guideline (where one of these recommendations appears, it is indicated as NICE TA 2006).

63

The guidance applies to the marketing authorisation held for each drug at the time of the appraisal.

64
65
66
54
Copyright © 2007, The British Psychological Society & The Royal College of Psychiatrists.

All rights reserved. No part of this book may be reprinted or reproduced or utilised in any form or by any electronic, mechanical, or other means, now known or hereafter invented, including photocopying and recording, or in any information storage or retrieval system, without permission in writing from the publishers. Enquiries in this regard should be directed to the British Psychological Society.

Bookshelf ID: NBK55462

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