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Dementia: Assessment, management and support for people living with dementia and their carers. London: National Institute for Health and Care Excellence (NICE); 2018 Jun. (NICE Guideline, No. 97.)
Dementia: Assessment, management and support for people living with dementia and their carers.
Show detailsThe cognitive problems associated with dementia are well established, but up to 90% of people with dementia may also be affected by non-cognitive symptoms of dementia. These symptoms can lead to significant changes in behaviour that include increased aggression, anxiety, apathy, agitation, depression, delusions, hallucinations and sleep disturbances.
These behaviours often reflect a high level of distress being felt by the person with dementia that they may not be able to communicate or understand, but these behaviours can also have significant adverse effects on the people involved in caring for the person with dementia. For example, the occurrence of sleep problems and wandering by people with dementia will disrupt their carer’s sleep patterns and is likely to have a severe effect on their carer’s mental state and ability to cope over time. Carer responses to these non-cognitive symptoms can also increase distress for the person with dementia and may lead to their being prescribed medication to try to control these behaviours. The inability of these treatments to successfully manage the non-cognitive behavioural symptoms may ultimately result in the institutionalisation of the person with dementia when the carer becomes unable to cope. However, staff within these care homes may also struggle to manage these behavioural issues and may in turn refer the person with dementia to specialist nursing care.
Thus, the non-cognitive symptoms associated with dementia have severe adverse effects on the person with dementia, family and both paid and unpaid carers. If these could be treated successfully this would have a big impact on the quality of life for everyone concerned and could lead to people with dementia being able to remain in their homes or with family.
There are a range of potential treatments for the non-cognitive symptoms of dementia which can be divided into two groups: pharmacological and non-pharmacological interventions. Pharmacological interventions are targeted to the problematic behaviour of the person with dementia and include the use of antidepressants, antipsychotics, mood stabilisers and drugs to modify sleep patterns. In contrast, non-pharmacological interventions take a wider view and may include approaches aimed at: resetting sleep patterns using bright light therapy or by increasing the activity levels of the person with dementia; calming and distracting an agitated person; and altering the carer’s behaviour to better cope with and manage the person with dementia. In addition, anxiety and depression may be treated using cognitive behavioural therapy, multisensory stimulation, relaxation and animal-assisted therapies.
This chapter focuses on the range of pharmacological and non-pharmacological interventions to address non-cognitive symptoms for which rigorous evidence from randomised controlled trials is available. The non-cognitive symptoms examined include depression, which is the subject of specific NICE guidance in its own right. However, it was decided that there were additional factors that needed to be taken into consideration for people with dementia and as a result depression was addressed in this specific context.
14.1. Interventions for treating illness emergent non-cognitive symptoms in people living with dementia
Review questions
- What are the most effective pharmacological interventions for managing illness emergent non-cognitive symptoms, such as psychosis, depression, behavioural changes in people living with dementia?
- What are the most effective non-pharmacological interventions for managing illness emergent non-cognitive symptoms, such as psychosis, depression, behavioural changes in people living with dementia?
14.1.1. Introduction
The aim of these review questions was to determine the effectiveness of different pharmacological and non-pharmacological interventions for treating illness emergent non cognitive symptoms in people living with dementia. The review identified studies that fulfilled the conditions specified in Table 77 and Table 78. For full details of the review protocols, see appendix C.
Table 77
Review summary: pharmacological interventions.
Table 78
Review summary: non-pharmacological interventions.
14.1.2. Evidence review
This review was conducted as an update from the previous dementia guideline (CG42). All included RCTs and systematic reviews from the previous guideline, together with all RCTs in included systematic reviews, were screened at title and abstract level. RCTs from included systematic reviews were excluded if they did not meet the criteria of enrolling patients with dementia and an illness-emergent non-cognitive symptom at baseline.
In addition, a systematic literature search for randomised controlled trials since the time of the last guideline identified 2,645 references. These were screened at title and abstract level, with 103 papers ordered as potentially relevant systematic reviews, 196 ordered as potentially relevant RCTs; 40 systematic reviews and 104 RCTs were ordered for pharmacological interventions; 63 systematic reviews and 92 RCTs were ordered as potentially relevant for non-pharmacological interventions. Finally, 21 papers identified through the literature search for the question on the management of pre-existing mental health conditions were also included as part of this question. Summaries of the included studies are provided below, with details of all excluded studies given in Appendix F.
For the full evidence tables and full GRADE profiles for included studies, please see Appendix E and Appendix G. References for the included studies are given in appendix I.
14.1.2.1. Description of included studies
14.1.2.1.1. Anxiety, depression, antidepressants and antipsychotics
Twenty-seven studies were included in the evidence review for this question, 16 on depression and/or anxiety (including 5 systematic reviews containing an additional 32 RCTs), 1 on antidepressants for other behavioural symptoms (a systematic review containing 9 RCTs), and 9 on the use of antipsychotics (including 3 systematic reviews containing an additional 33 RCTs). A systematic review of memantine for mild Alzheimer’s disease was also identified, containing 3 RCTs. A summary of the included studies is given in Table 79.
14.1.2.1.2. Sleep problems
Nine studies were included in the evidence review for this question, consisting of 7 RCTs and 2 systematic reviews containing 5 additional RCTs. A summary of the included studies is given in Table 80. One additional study was identified during the rerun process, but this was excluded at full text screening.
14.1.2.1.3. Agitation and aggression
Twenty-eight studies were included in the evidence review for this question, 22 RCTs and 6 systematic reviews containing 42 additional RCTs. A summary of the included studies is given in Table 81.
14.1.2.2. Summary tables for included studies
14.1.2.2.1. Anxiety, depression, antidepressants and antipsychotic
Table 79
Included studies for anxiety, depression, antidepressants and antipsychotics.
14.1.2.2.2. Sleep problems
Table 80
Included studies for sleep problems.
14.1.2.2.3. Agitation and aggression
Table 81
Included studies for agitation and aggression.
14.1.3. Health economic evidence
14.1.3.1. Systematic review of published economic evaluations
A systematic literature search was undertaken to identify existing cost–utility analyses (CUAs) evaluating the most effective pharmacological and non-pharmacological interventions for managing illness emergence non-cognitive symptoms in people living with dementia. In total, 2,385 articles were returned. In total, 4 publications were judged to be at least partially applicable to the review questions and were therefore included. Details of the literature search are provided in Appendix D.
14.1.3.2. Antidepressants
Banerjee et al. (2013) compared the cost effectiveness of sertraline and of mirtazapine with placebo, for the treatment of depression in people with Alzheimer’s disease referred to oldage psychiatry services. Romeo et al. (2013) present the same study and analysis in a separate publication. The authors conducted a cost–utility analysis alongside the HTA-SADD RCT of 326 participants, collecting primary service-use and EQ-5D data. The primary analysis was a cost-effectiveness analysis with change in the Cornell Scale for Depression and Dementia as the health outcome. A secondary analysis considered incremental QALYs. A 39-week time horizon was taken for this secondary analysis, matching the trial duration. There was no extrapolation beyond the trial duration. For further details, please see the economic evidence profile in Appendix M.
Service-use data included direct costs associated with hospital-based care, community-based care and day services recorded during the follow-up period. Informal care data (unpaid carer costs) were also collected. QALYs were estimated using data obtained from the EQ-5D questionnaire. The authors performed non-parametric bootstrapping to generate additional pairs of incremental cost and QALY outcomes in order to present a cost-effectiveness acceptability analysis. The mean results with informal care costs excluded are presented in Table 82.
Table 82
Base-case cost–utility results – Banerjee (2013) and Romeo (2013).
The base-case analysis produces an ICER of £8,080 per QALY for mirtazapine compared with placebo, and shows sertraline to be dominated by mirtazapine. There is large uncertainty around the incremental costs and QALYs, with all 95% confidence intervals crossing zero. In addition, some estimates are conspicuously skewed, especially estimated incremental QALYs for mirtazapine compared with placebo: the 95% confidence interval ranges from −0.1 to +0.1, but the mean is +0.05 QALYs. Despite its low mean ICER compared with placebo, mirtazapine is shown to have only approximately 20% probability of being cost-effective at a threshold value of £20,000/QALY. Mirtazapine is shown to have a probability in excess of 90% of being cost-effective compared with sertraline at all threshold values. Deterministic sensitivity analysis was not presented for analyses which excluded informal care costs. The authors conclude that their analysis provides no support for the use of antidepressants as first-line therapy for depression in people with Alzheimer’s disease referred to old-age psychiatry services.
14.1.3.3. Antipsychotics
Rosenheck et al. (2007) compared the cost effectiveness of olanzapine, quetiapine and risperidone with placebo, for the treatment of psychosis and aggression in people with Alzheimer’s disease in ambulatory outpatients living at home or in assisted living. The authors conducted a cost–benefit analysis alongside Schneider et al. (2006) (n=421), assessing quality-adjusted life-years (QALYs) using the Health Utilities Index Mark. This was supplemented by the Alzheimer’s Disease Related Quality of Life Scale, the Alzheimer’s disease Cooperative Study Activities of Daily Living Scale (ADCS-ADL) and the AD Dependence Scale. A secondary analysis excluded observations after the first medication change. For further details, please see the economic evidence profile in Appendix M.
Service-use data included direct costs associated with experimental medication costs. Concomitant medication cost and monthly health service costs were also collected. The authors performed an analyses of net health benefits when the value of health benefits was valued at $50,000 per QALY and $100,000 per QALY. The mean results with concomitant medication cost and monthly health service costs excluded are presented in Table 83.
Table 83
Base-case cost–utility results – Rosenheck et al., (2007).
The base-case analysis suggests that olanzapine is dominated by placebo as placebo is cheaper and produces more health benefits. Quetiapine and risperidone both produced a very small incremental health benefit (of +0.01 and +0.02 QALY, respectively), but also result in relatively large costs, with the result that risperidone produces an ICER of $264,600/QALY compared with placebo, and quetiapine is extendedly dominated by placebo and risperidone. At the cost-effectiveness thresholds of $50,000 and $100,000 per QALY considered by the authors, no intervention was found to be cost-effective.
Kirbach et al. (2008) compared the cost effectiveness of olanzapine with no treatment, for the treatment of agitation and psychosis in people with Alzheimer’s disease in the USA. The authors created a Markov model, with a 6-month cycle length and a 13-year treatment horizon Transition probabilities for Alzheimer’s disease progression were taken from the Consortium to Establish a Registry for Alzheimer’s disease (CERAD) cohort, in which there was a 70% prevalence for agitation and up to 36% prevalence for varying psychoses. In common with Rosenheck et al. (2007), Kirbach et al. (2008) used results from Schneider et al. (2006) to estimate olanzapine cost-effectiveness. Economic evidence profiles for both studies are available in Appendix M.
The study considered both ‘direct’ and ‘indirect’ costs, though did not specify what each comprised. The results presented here are from analyses of ‘direct’ costs only, as these were judged less likely to include items that are beyond the NICE reference case. Utility weights used to estimate QALYs were provided by Murman and Colenda (2005).
Table 84
Base-case cost–utility results – Kirbach et al (2008).
The base-case analysis (Table 84) suggests that treatment with olanzapine incurs additional costs (primarily due to cost of the drug itself) but also provides QALY gains, with an ICER of $37,104 per QALY. Several 1-way, 2-way and 3-way deterministic sensitivity analyses produced ICERs ranging from $31,336 to $42,039.
However, this finding is at odds with Rosenheck et al. (2007) (see above), which is noteworthy, given that both models relied on the same evidence to estimate the effectiveness of olanzapine.
14.1.3.4. Non-pharmacological interventions
Livingston et al. (2014) compared the cost effectiveness of a 6-month, multimodal, nonpharmacological intervention with usual care, for reducing agitation in people with dementia. The intervention comprised music-based group therapy, structured teaching with a therapist, psychoeducational staff training by a psychologist and intensive family member–staff communication comprising provision of basic information, everyday availability of professional carers to answer family members’ questions, and a 1-hour session of psychoeducational counselling by a psychologist to a close family member of each participant. For further details, please see the economic evidence profile in Appendix M.
Service-use data included direct costs associated with providing the treatment including staff time. Data from a longitudinal epidemiological study (LASER-AD) were used to quantify the relationship between agitation and health and social care costs and agitation and utility. The analysis adopted a 12-month time horizon.
Table 85
Base-case cost–utility results – Livingston et al. (2015).
Base-case results (Table 85) suggest that, although the treatment cost £406 to provide to each patient, the net cost impact was a saving of £716 compared with usual care. This was due to a reduction in the costs of managing agitation. The intervention was also more effective than the comparator, so is considered dominant. PSA suggested that the intervention had an 82.2% probability of being cost effective, if QALYs are valued at £20,000 each.
This analysis, however, had some serious limitations. Critically, data for treatment effects were from a paper published by Fischer-Terworth and Probst (2011), a non-randomised study with a small number of participants (n=49).
Zwijsen et al. (2016) compared the cost effectiveness of a non-pharmacological intervention (‘Grip on Challenging Behaviour’; GRIP), for the management of challenging behaviour in dementia special care units in comparison with usual care in the Netherlands. The economic evaluation was performed from a societal perspective alongside a cluster-randomised controlled trial (Zwijsen et al., 2011; see 14.1.2, above). QALYs were estimated using the EQ-5D. Challenging behaviour and quality of life was assessed on 5 different occasions, each 4 months apart. For further details, please see the economic evidence profile in Appendix M.
Costs were estimated using standard Dutch sources. Staff time was estimated using prospective 1-monthy diaries.
Table 86
Base-case cost–utility results – Zwijsen et al. (2016).
The base-case analysis (Table 86) suggests that GRIP is associated with increased costs and less QALYs compared with usual care. Probabilistic analysis showed that the probability of GRIP being cost-effective in comparison with usual care was zero regardless of the value placed on a QALY. The authors concluded that GRIP was not considered cost-effective in comparison with usual care.
14.1.3.5. Exercise
D’Amico et al. (2016) conducted a cost–utility analysis alongside EVIDEM-E RCT, evaluating a 12-week trial of a dyadic exercise regimen (tailored walking) for people living with dementia and their main carer as therapy for behavioural and psychological symptoms of dementia. For further details, please see the economic evidence profile in Appendix M.
Data on care and support service use were collected using an adapted version of the Client Service Receipt Inventory. Unit costs were taken from standard sources (PSSRU, BNF), if possible, and estimated from market sources if not. All costs were expressed in 2011 UK pounds. QALYs were calculated for participants with dementia only, using the DEMQOL-Proxy, completed by the carer, with societal weights.
Table 87
Base-case cost–utility results from a health and social care perspective for exercise compared with control for D’Amico et al. (2016).
Base-case results from a health and social care perspective (Table 61) show that exercise was associated with lower costs and higher QALYs than control, resulting in the being a dominant. However, findings were very uncertain in both cost and effect dimensions. The cost savings of the exercise group compared with the control group appear to be driven by less usage of hospital services by those in the exercise group; however, the authors note that neither the costs or QALY difference were statistically significant.
14.1.4. Evidence statements
14.1.4.1. Anxiety and depression
14.1.4.1.1. Pharmacological treatment
Sertraline vs placebo
Low-quality evidence from up to 3 RCTs containing 348 people could not differentiate levels of depressive symptoms (Cornell Scale for Depression in Dementia/Hamilton Depression rating Scale) between people taking sertraline and placebo at any time between 12 and 39 weeks.
Low- to moderate-quality evidence from up to 2 RCTs containing 217 people could not differentiate global impression of change scores (mADCS-CGIC), cognition (MMSE), activities of daily living, neuropsychiatric symptoms (NPI) or quality of life (self- or carer-reported) between people taking sertraline and placebo at any time between 12 and 39 weeks.
Moderate- to high-quality evidence from 1 RCT containing 173 people found worse levels of carer mental health (GHQ/SF-12) in carers of people taking sertraline compared with placebo at 13 weeks, but could not differentiate levels at 39 weeks, or carer burden or physical health at 13 or 39 weeks.
Moderate-quality evidence from 3 RCTs containing 385 people found higher levels of adverse events in people taking sertraline compared with placebo, but very low-quality evidence from 2 RCTs containing 348 people could not differentiate levels of serious adverse events.
Mirtazapine vs placebo
Low-quality evidence from 1 RCT containing 158 people could not differentiate levels of depressive symptoms (Cornell Scale for Depression in Dementia) between people taking mirtazapine and placebo at 13 or 39 weeks.
Low- to moderate-quality evidence from 1 RCT containing 158 people could not differentiate cognition (MMSE), activities of daily living, neuropsychiatric symptoms (NPI) or quality of life (self- or carer-reported) between people taking mirtazapine and placebo at 13 or 39 weeks.
Moderate-quality evidence from 1 RCT containing 158 could not differentiate levels of carer burden, physical or mental health between carers of people taking mirtazapine and placebo at 13 or 39 weeks.
Moderate-quality evidence from 1 RCT containing 215 people found higher levels of adverse events in people taking mirtazapine compared with placebo, but low-quality evidence from the same study could not differentiate levels of serious adverse events.
Antidepressants vs placebo
Low-quality evidence from a systematic review containing 10 RCTs could not identify evidence of significant benefit with antidepressants compared with placebo for the management of depressive symptoms in people with dementia.
Low-quality evidence from a systematic review containing 11 studies (5 RCTs) could not identify evidence of significant benefit with pharmacological treatment compared with placebo for the management of depressive symptoms in people with Huntington’s disease.
14.1.4.1.2. Psychological treatment vs usual care
Low-quality evidence from 6 RCTs containing 439 people found lower levels of depressive symptoms in people offered psychological treatment compared with usual care.
Low- to moderate-quality evidence from up to 2 RCTs containing 65 people found lower levels of anxiety (RAID) in people offered psychological treatment compared with usual care, but could not differentiate levels of anxiety as measured by self-rating or the NPI-A.
Very-low to low-quality evidence from up to 4 RCTs containing 381 people could not differentiate levels of quality of life (self-report or proxy), activities of daily living, neuropsychiatric symptoms, cognition (MMSE) or carer depressive symptoms between people offered psychological treatment compared with usual care.
14.1.4.1.3. PATH vs ST-CI
Low- to moderate-quality evidence from 1 RCT containing 74 people with either dementia (n=39) or mild cognitive impairment (n=35) found lower levels of depressive symptoms and disability in people offered the PATH intervention compared with the ST-CI intervention for depression.
14.1.4.1.4. Structured depression management vs usual care (in nursing homes)
Moderate-quality evidence from 1 RCT containing 393 people could not differentiate levels of depressive symptoms (Cornell Scale for Depression in Dementia/Geriatric Depression Scale) or severe depression between people offered structured depression management compared with usual care.
High-quality evidence from 1 RCT containing 393 people found higher levels of quality of life (EQ-VAS) in people offered structured depression management compared with usual care.
14.1.4.1.5. Psychogeriatric management vs usual care
Moderate-quality evidence from 1 RCT containing 45 people could not differentiate levels of depressive symptoms or psychosis between people offered psychogeriatric case management, psychogeriatric consultation or usual care.
14.1.4.1.6. Ambient bright lighting
Very low- to low-quality evidence from 1 RCT containing 66 people found higher levels of depressive symptoms (Cornell Scale for Depression in Dementia) in men exposed to bright morning light compared with standard lighting, but could not differentiate levels in those exposed to bright evening or all-day light compared with standard lighting, or in women in any lighting conditions.
14.1.4.1.7. Music therapy
Group music therapy
Moderate-quality evidence from a systematic review containing 8 studies (5 RCTs) could not identify evidence of significant benefit of group music therapy compared with standard therapy or non-music interventions for the management of anxiety in people with dementia.
Active music therapy
Low-quality evidence from a systematic review containing 10 studies (3 RCTs) could not identify evidence of significant benefit with active music therapy compared with usual care or non-music interventions for the management of anxiety and depressive symptoms in people with dementia.
Active music therapy vs reading
Low-quality evidence from 1 RCT containing 47 people could not differentiate levels of quality of life (DQOL) or depressive symptoms (Geriatric Depression Scale) between people offered active music therapy compared with reading therapy.
Preferred music listening vs usual care
Very-low quality evidence from 1 RCT containing 52 people could not differentiate levels of anxiety (RAID) between people offered preferred music listening compared with usual care.
14.1.4.1.8. High-intensity exercise vs non-exercise activity program
Low- to moderate-quality evidence from 1 RCT containing 184 people could not differentiate levels of anxiety (RAID) or depressive symptoms (Geriatric Depression Scale/MADRS) between people offered high-intensity exercise compared with a non-exercise activity program.
14.1.4.2. Antidepressants for other non-cognitive symptoms
Very low- to moderate-quality evidence from up to 4 RCTs containing 419 people found improvements in scores on the Cohen-Mansfield Agitation Inventory with SSRIs versus placebo, but could not differentiate total neuropsychiatric symptoms, behavioural symptoms or adverse events.
Very low- to moderate-quality evidence from up to 2 RCTs containing 103 people could not differentiate any outcome measures between SSRIs and atypical antipsychotics, SSRIs and typical antipsychotics, trazodone and placebo, or trazadone and typical antipsychotics.
14.1.4.3. Antipsychotics
14.1.4.3.1. Atypical antipsychotics versus placebo
Moderate- to high-quality evidence from up to 17 RCTs containing 5,028 people found improvements in the NPI, Brief Psychiatric Rating Scale, Cohen-Mansfield Agitation Inventory and Clinical Global Impression of Change with atypical antipsychotics versus placebo, but higher rates of mortality, somnolence, and extrapyramidal and cerebrovascular adverse events.
14.1.4.3.2. Olanzapine vs haloperidol
Low-quality evidence from 1 RCT containing 58 people could not differentiate cognition (MMSE), anxiety (CMAI) or neuropsychiatric symptoms (NPI) between people taking olanzapine and haloperidol.
14.1.4.3.3. Risperidone vs rivastigmine
Moderate-quality evidence from 1 RCT containing 27 people found lower levels of anxiety in people taking risperidone versus rivastigmine.
14.1.4.3.4. Antipsychotic withdrawal
High-quality evidence from 7 RCTs containing 366 people found a higher proportion of people who discontinued antipsychotics had a worsening of behavioural and psychological symptoms of dementia compared with those who continued, but low- to moderate-quality evidence from up to 6 RCTs containing 462 people could not differentiate overall levels of behavioural and psychological symptoms of dementia, or rates of early study termination or mortality.
Moderate-quality evidence from 1 RCT containing 109 people could not differentiate levels of cognition (SIB/MMSE), neuropsychiatric symptoms (NPI), Parkinsonism (modified UPDRS), activities of daily living (BADL) or language difficulties (STALD/FAS) between people who continued antipsychotic medication compared with those who discontinued.
High-quality evidence from 1 RCT containing 109 people found higher levels of neuropsychiatric symptoms (NPI) in people who discontinued antipsychotic medication compared with those who continued, but moderate-quality evidence from the same study could not differentiate levels of cognition (SIB)
High-quality evidence from 1 RCT containing 165 people found lower levels of mortality in people who discontinued antipsychotic medication compared with those who continued.
14.1.4.3.5. Antipsychotic switch to memantine
Moderate-quality evidence from 1 RCT containing 164 people could not differentiate levels of agitation (CMAI), neuropsychiatric symptoms (NPI), cognitions (MMSE), activities of daily living (BADL), serious adverse events or mortality between people on antipsychotics at baseline who either continued on antipsychotics or were switched to memantine.
14.1.4.3.6. Enhanced psychosocial care
Moderate-quality evidence from 1 RCT containing 338 people found a lower proportion of people taking antipsychotics in homes that offered an enhanced psychosocial care intervention compared with usual care, but very low- to low-quality evidence from the same study could not differentiate rates of falls or levels of aggression and wellbeing.
14.1.4.4. Memantine vs placebo
Low-quality evidence from 3 RCTs containing 427 people could not differentiate cognition (ADAS-cog), activities of daily living (ADCS-ADL) or neuropsychiatric symptoms (NPI) between people with mild Alzheimer’s disease taking memantine versus placebo.
14.1.4.5. Sleep problems
14.1.4.5.1. Melatonin vs placebo
Very low- to moderate-quality evidence from up to 3 RCTs containing 195 people could not detect a difference in total night-time sleep time, ratio of daytime to night-time sleep, sleep efficiency, nocturnal time awake, number of night-time awakenings, carer-rated sleep activity, activities of daily living, sleep latency or numbers of adverse events between people with sleep problems taking melatonin versus placebo.
14.1.4.5.2. Trazadone vs placebo
Moderate- to high-quality evidence from 1 RCT containing 30 people found higher levels of total night-time sleep and better sleep efficiency in people with sleep problems taking trazadone versus placebo over a two week period, but could not differentiate numbers of night-time awakenings, total daytime sleep, number of daytime naps or activities of daily living.
14.1.4.5.3. Memantine vs placebo
Low- to moderate-quality evidence from 1 RCT containing 60 people found a reduction in REM sleep behaviour disorder (measured using the Stavanger Sleep Questionnaire) in people with sleep problems taking memantine versus placebo, but could not differentiate scores on the Epworth Sleepiness Scale.
14.1.4.5.4. Light therapy
Low-quality evidence from 2 RCTs containing 48 people could not detect a difference in total sleep duration, sleep latency, night-time activity counts or the number of night-time awakenings in people with dementia and sleep problems exposed to bright light therapy.
14.1.4.5.5. Slow-stroke back massage
Moderate-quality evidence from 1 RCT containing 40 people could not detect a difference in total night-time sleep time or sleep efficiency in people with dementia and sleep problems exposed to massage therapy for 2 nights.
14.1.4.5.6. Multicomponent non-pharmacological interventions vs usual care
Moderate- to high-quality evidence from up to 3 RCTs containing 207 people found improvements in total night-time sleep, total night-time awake time and scores on the Sleep Disorders Inventory in people offered a multicomponent non-pharmacological intervention including light exposure, exercise, environmental modification and sleep hygiene advice versus usual care, but could not differentiate number of night-time awakenings, total daytime sleep or depressive symptoms.
14.1.4.5.7. Individualised activities
Low- to moderate-quality evidence from 1 RCT containing 50 people found a reduction in the amount of daytime sleep in people with dementia and a sleep efficiency of <50% at baseline exposed to individualised social activities for 21 days, but could not differentiate the day/night sleep ratio or the number of night-time minutes to sleep onset, night-time minutes slept, night-time sleep efficiency or night-time minutes awake.
14.1.4.5.8. Continuous positive air pressure
Moderate-quality evidence from 1 RCT containing 39 people did not detect a difference in the Epworth Sleepiness Scores in people with dementia and sleep disordered breathing treated with continuous positive air pressure compared with sham intervention for 3 weeks.
14.1.4.6. Non-pharmacological management of agitation, aggression and apathy
14.1.4.6.1. Sensory interventions
Moderate-quality evidence from up to 5 RCTs containing 446 people could not differentiate levels of agitation, positive affect, negative affect, depressive symptoms, quality of life, behavioural pathology or cognition between people offered sensory interventions or usual care.
14.1.4.6.2. Social contact
Very low-quality evidence from 1 RCT containing 164 people could not differentiate levels of agitation between people offered social contact interventions (simulated presence or pet therapy) or usual care.
14.1.4.6.3. Activities
Low- to moderate-quality evidence from up to 6 RCTs containing 465 people found reduced levels of negative affect and increased levels of pleasurable and interested affect in people offered activity based intervention versus usual care, but very low- to low-quality evidence could not differentiate levels of agitation, constructive engagement or negative engagement.
14.1.4.6.4. Care delivery interventions
Very low-to moderate quality evidence from up to 5 RCTs containing 71 people could not differentiate levels of agitation, aggressive behaviours, or rates of psychotropic prescription in centres offered or not offered a care delivery intervention, but found higher rates of antidepressant and cholinesterase inhibitor prescriptions in centres that offered the intervention.
14.1.4.6.5. Staff training
Moderate- to high-quality evidence from 1 RCT containing 272 people found reduced levels of anxiety and verbally aggressive behaviours in centres offered a staff training intervention, but could not differentiate levels of physically aggressive behaviours.
14.1.4.6.6. Herbal extracts
Low- to high-quality evidence from up to 4 RCTs containing 1,596 people found improved NPI scores, activities of daily living, quality of life and cognition in people offered ginkgo biloba extract versus placebo.
14.1.4.7. Pharmacological management of agitation, aggression and apathy
14.1.4.7.1. Mood stabilisers vs placebo
Very low- to high-quality evidence from up to 4 RCTs containing 254 people found NPI scores, cognition (MMSE) and adverse events were significantly worse in people offered mood stabilisers versus placebo, but could not differentiate levels of agitation (CMAI; NPI BPRS subscale), total neuropsychiatric symptoms or physical self-maintenance.
14.1.4.7.2. Cholinesterase inhibitors versus usual care
Low- to high-quality evidence from up to 3 RCTs containing 317 people found global assessment, agitation (NPI subscale) and cognition were significantly better in people offered cholinesterase inhibitors versus placebo, but could not differentiate levels of agitation (CMAI) or total neuropsychiatric symptoms (NPI).
14.1.4.7.3. Memantine versus placebo
Moderate- to high-quality evidence from 1 RCT containing 149 people found significantly lower NPI scores in people offered memantine versus placebo but could not differentiate levels of agitation, global assessment, clinician assessment or cognition.
14.1.4.7.4. Tetrahydrocannabinol versus placebo
Moderate-quality evidence from 1 RCT containing 47 people could not differentiate levels of agitation (CMAI; NPI agitation aggression subscale), neuropsychiatric profile, aberrant behaviours, clinician global assessment, activities of daily living or quality of life in people offered tetrahydrocannabinol versus placebo.
14.1.4.7.5. Prazosin versus placebo
Very low- to low-quality evidence from 1 RCT containing 13 people found improvements in psychiatric assessment and global assessment in people offered prazosin versus placebo, but could not differentiate neuropsychiatric profile (NPI).
14.1.4.7.6. Dextromethorphan-quinidine vs placebo
Moderate- to high-quality evidence from 1 RCT containing 279 people found improved neuropsychiatric symptoms (NPI), agitation/aggression and depressive symptoms (Cornell scale) but higher levels of adverse events in people offered dextromethorphan-quinidine versus placebo. The evidence could not differentiate global assessment, cognition, quality of life, serious adverse events or mortality.
14.1.4.7.7. Modafinil vs placebo
Moderate-quality evidence from 1 RCT containing 22 people could not differentiate levels of apathy, function, activities of daily living or carer burden between people offered modafinil versus placebo.
14.1.4.7.8. Donepezil and choline alphoscerate vs donepezil
High-quality evidence from 1 RCT containing 113 people found improved levels of apathy, neuropsychiatric symptoms (NPI) and cognition (MMSE, ADAScog) in people offered donepezil and choline alphoscerate versus donepezil alone.
14.1.4.8. Health economic evidence
14.1.4.8.1. Antidepressants
One directly applicable cost–utility analysis with very serious limitations found that mirtazapine has a probability in excess of 90% of being superior to sertraline, regardless of the assumed value of a QALY, but it only had a probability of approximately 20% of being associated with an ICER of £20,000 per QALY or better compared with placebo. The study undertook only limited exploration of uncertainty and had a short time horizon.
14.1.4.8.2. Antipsychotics
Two partially applicable cost–utility analyses from the USA explored the cost effectiveness of second-generation antipsychotics compared with each other and/or usual care.
- One RCT-based analysis with potentially serious limitations found that there were no significant differences in QALYs across the treatment groups, with olanzapine being worse than placebo. Both risperidone and sertraline produced very small increases in QALYs which were insufficient to outweigh additional costs even when QALYs are valued at $100,000 each.
- One analysis with very serious limitations, based on an observational study, found that, assuming QALYs are valued at $50,000 each or more, olanzapine is likely to be considered cost-effective, compared with usual care, for the treatment of agitation and psychosis in Alzheimer’s disease. However, effect data were drawn from a study that found that olanzapine resulted in a loss of QALYs.
14.1.4.8.3. Non-pharmacological interventions
One directly applicable cost–utility analysis with very serious limitations explored a multimodal, non-pharmacological intervention consisting of music therapy, sensory interventions and training. The intervention was found to have a 82% probability of being cost effective if QALYs are valued at £20,000 each. However, the analysis relied on a nonrandomised study with a small number of participants (n=49) for effects.
One partially applicable economic evaluation with potentially serious limitations, which was performed alongside a cluster RCT in the Netherlands, found that the Grip on Challenging Behaviours care programme (GRIP) was less effective and more expensive than usual care.
14.1.4.8.4. Exercise
One partially applicable cost–utility analysis with minor limitations conducted alongside an RCT explored the cost effectiveness of a dyadic exercise regimen for people living with dementia and their main carer as therapy for behavioural and psychological symptoms of dementia. Exercise was found to result in lower costs and higher QALYs than control, resulting in the exercise intervention being dominant. The authors noted that neither the costs nor QALY difference were statistically significant.
14.1.5. Evidence to recommendations
14.1.5.1. Pharmacological interventions
| Relative value of different outcomes | The committee agreed that evaluations of most interventions depended on 3 components; whether the intervention improves the specific symptom(s) it is targeting; whether there are any broader impacts on cognition, function or wellbeing; and adverse events. Many pharmacological treatments are known to have worse adverse event profiles in people with cognitive decline than in people without, and therefore the committee agreed this trade-off was always an important one to consider. Sleep disturbances The committee agreed that whilst daytime sleep was a relevant outcome, the most important individual measure would be of nocturnal time awake, as this is a particular issue that can impact on carer quality of life. It also agreed that it would be important to consider participant and carer reported outcomes alongside the actigraph measurements which are commonly reported in trials of sleep disturbances. |
|---|---|
| Trade-off between benefits and harms | Depression and anxiety The committee agreed the evidence did not show significant benefits from using antidepressants to treat mild to moderate depression in people with mild to moderate dementia. In particular, the large DIADS-2 and HTA-SADD studies did not produce any positive findings. Whilst only 2 specific antidepressants were tested in these trials, the committee agreed this was likely to represent a class effect, and therefore any recommendation made should apply to all antidepressants. There were, however, specific caveats that the committee agreed were important. First, it agreed that it would not be appropriate to extrapolate these findings to people with either severe depression (where there may be an urgent need for treatment) or severe dementia. Second, it agreed that if someone had previously responded well to antidepressant treatment, then it would be appropriate to use the same treatment if the person later develops dementia. Antipsychotics The committee agreed there was a clear pattern in the evidence for antipsychotics. They showed clear evidence of efficacy (reductions in agitation and NPI scores), but also evidence of significant harms, with increase in rates of all types of adverse events, and mortality. The committee agreed that the significant risks of treatment meant their use should be restricted as much as possible, and limited only to situations either where there is an urgent need for treatment to prevent harm to the person living with dementia or others, or where the use is for the treatment of an underlying psychosis, and would be equally appropriate in a person who does not have dementia. The committee also agreed that a specific discussion is necessary with the person living with dementia and their carers/family members about the benefits and harms of treatment. It agreed that treatment should be restricted to the lowest effective does and the shortest possible time, in order to reduce adverse events as far as possible. The committee agreed that it was necessary to regularly review people taking antipsychotics to ensure the treatment is still necessary, and to encourage a discussion about discontinuation wherever this is possible. It also agreed that the use of an antipsychotic was not a reason to discontinue non-pharmacological treatment, and that people either taking or being discontinued from antipsychotics should have access to the same range of non-pharmacological options as people not being treated with antipsychotics. It was noted that the majority of the included studies were for non-cognitive symptoms such as agitation or similar behavioural symptoms, rather than as treatments for psychosis. It was also agreed to be appropriate to add a specific recommendation in the guideline around the risk of worsening motor features and antipsychotic sensitivity reactions in people with Parkinson’s disease dementia or dementia with Lewy bodies taking antipsychotics. This recommendation links to the NICE guideline on Parkinson’s disease, which contains additional recommendations on this topic. Sleep disturbances The committee agreed the evidence did not show significant benefit from using melatonin to treat insomnia in people with Alzheimer’s disease, and that the evidence base contained a sufficiently large sample size that any meaningful benefit would have been detected. As a result of this and the known adverse events associated with melatonin treatment (including headaches and dizziness) the committee agreed it should not be used to manage insomnia. The committee agreed it was not appropriate to extrapolate this evidence to other subtypes of dementia. For example, melatonin is used to treat REM sleep disorder in people with Parkinson’s disease, and the committee did not want to restrict its use for people with Parkinson’s disease dementia or dementia with Lewy bodies without robust evidence. The committee agreed that the evidence for trazadone was promising, but noted that since the trial only had a 2 week duration it was unclear whether the increase in night-time sleep time would be sustained long-term. The committee agreed that the full effects of trazodone could take longer to be detected and that the increase in night-time sleep detected here could be due to the sedative effect of the drug rather than an effect on sleeping per se. In addition it agreed that the lack of improvement in carer reported outcomes was an issue and that the side-effects of trazadone treatment should also be considered before prescription. It therefore decided against recommending the use of trazadone, but included a research recommendation to examine the effectiveness of pharmacological interventions to treat sleep problems in people with dementia who had failed to respond to non-pharmacological interventions. Agitation, aggression and apathy The committee agreed the evidence relating to the use of valproate was demonstrably robust. It noted the significant presence of adverse events in people living with dementia receiving the intervention, but recognised that this was contrary to the beneficial effect mood stabilisers can have in non-dementia specific populations. As a result, the committee agreed it would be appropriate to recommend limiting the use of valproate in people living with dementia to those with pre-existing mood disorders only (specifically, in situations where they had already shown effectiveness before the onset of cognitive decline). The committee noted there was only very limited evidence on other mood stabilisers, and therefore it was appropriate to restrict the recommendation solely to valproate. In addition, the committee noted that preliminary findings regarding the use of dextromethorphan-quinidine for agitation in people living with dementia, and donepezil plus choline alphoscerate for the management of apathy in people living with dementia did show some positive preliminary results. Although these results were limited the committee agreed it would be beneficial to pursue these lines of research and suggested these would be appropriate topics in which to make research recommendations. |
| Trade-off between net health benefits and resource use | Depression and anxiety The committee noted that the findings of the economic evaluation conducted alongside the HTA-SADD trial were also negative, with mirtazapine only having a 20% probability of being cost-effective versus placebo at £20,000/QALY, and sertraline an even lower probability. The committee agreed this added further justification to their conclusion that antidepressants not be routinely used in this population. Antipsychotics The committee agreed that the most robust economic evidence available in this area came from the Rosenheck et al publication conducted alongside the CATIE-AD trial. This study concluded that antipsychotic treatment was not cost-effective for the trial population, and the committee agreed this further supported their conclusion that treatment should be restricted to those cases where it is urgently needed. Sleep disturbances No economic evidence was identified for sleep disturbances, but the implementation of the negative recommendation for melatonin was agreed to be likely to be cost-saving. Agitation, aggression and apathy No positive recommendations were made for pharmacological treatment for agitation, aggression and apathy, and therefore the committee was not concerned by the lack of economic evidence identified. |
| Quality of evidence | Depression and anxiety The committee agreed that both the DIADS-2 and HTA-SADD trials were of good quality, with sufficiently large sample sizes that it would be reasonable to expect an effect to have been detected, if a meaningful one was present at the population level. It agreed that whilst there may be individual people who respond well to antidepressants, it is not usually possible to identify these people prospectively, and therefore no specific recommendations could be made for this group. Antipsychotics The committee agreed that there were good quality studies with large sample sizes looking at both antipsychotic efficacy and the effects of antipsychotic discontinuation. There were also long-term studies looking at the effects of antipsychotics on mortality, and therefore the committee agreed there was a robust evidence base behind the recommendation made. Sleep disturbances The committee noted that since the trazadone trial only ran for 2 weeks and involved a small number of participants, care was needed in interpreting the positive findings presented. The committee were concerned about the use of the Epworth Sleepiness Scale and Stavanger Sleep Questionnaire as primary outcome measures in the Larsson study. Combined with the lack of actigraph data and carer outcomes this led it to rate the study quality as poor and as a result they lacked confidence in the reported improvement in REM sleep disorder presented. Agitation, aggression and apathy The committee observed that aside from the evidence relating to mood stabilisers, the evidence from all other pharmacological interventions associated with the management of agitation, aggression or apathy came from a limited number of RCTs or single studies only. For this reason the committee were cautious and agreed it would be inappropriate to make broad based recommendations on these interventions without a more comprehensive evidence base. |
| Other considerations | A common exclusion criteria across many of the trials in this review was either people who were deemed to need treatment sufficiently urgently that they could not be included in the study, or had sufficiently severe symptoms that randomisation was not considered appropriate. Therefore, the majority of the evidence base consists of people not considered at urgent need of treatment, and it is unlikely that RCTs would be conducted in this very severe population. Therefore, the committee agreed it was important to note that the recommendations made focus on this non-urgent population, and individual clinician judgement would be important in those people where it was felt there was an urgent need for intervention to prevent harm to the individual. |
14.1.5.2. Non-pharmacological interventions
| Relative value of different outcomes | The committee agreed that evaluations of most interventions depended on 3 components; whether the intervention improves the specific symptom(s) it is targeting; whether there are any broader impacts on cognition, function or wellbeing; and adverse events. |
|---|---|
| Trade-off between benefits and harms | Depression and anxiety The committee agreed there was evidence of efficacy for psychological treatments in the management of depression and anxiety. There were significant reductions in overall levels of depression across the studies, as well as reductions in the primary anxiety measure in the 2 studies where people were required to have elevated levels of anxiety at study entry. The population in the studies was composed of people with mild to moderate dementia and mild to moderate depression, and therefore the committee agreed it was appropriate to make a recommendation for this group. The only other intervention which showed evidence of benefit was the PATH intervention, but this was conducted in a setting where only around 50% of the people had dementia (the rest having mild cognitive impairment), and since the results were not reported separately for the 2 populations, the committee were not confident to conclude the intervention was specifically effective for people living with dementia. Managing distress The committee agreed that reactions which are classified as behavioural symptoms of dementia were often responses to other underlying problems in the context of difficulty in communicating needs effectively. For example, people with pain or delirium or who are responding to inappropriate care may be labelled as having behavioural problems when in fact there is a need to treat the underlying pain or delirium, and/or to improve the environment. The committee therefore agreed that, before any interventions for distress are considered, it is important that a thorough structured assessment of the person and their environment be conducted to try and identify and address the underlying causes of distress. If this assessment is unsuccessful in identifying approaches that can resolve the problem, then in view of the clearly established harms of antipsychotics, the committee agreed it was appropriate that non-pharmacological management (both environmental and psychosocial) be offered before any thought is given to the use of antipsychotics. The committee also noted that the evidence showed that staff training in appropriate use of non-pharmacological methods showed the use of antipsychotics could be significantly reduced without any subsequent increase in neuropsychiatric symptoms, and therefore it was agreed this would form an appropriate part of the training staff should receive in managing non-cognitive symptoms (this is included as part of a recommendation in section 16 on staff training). The committee also noted the evidence on two somewhat different approaches to managing symptoms; more structured psychosocial interventions and less structured interventions based around offering enjoyable and personalised activities. The committee agreed it was appropriate for both to be mentioned in the recommendations as they may each be useful in different situations. Sleep disturbances The committee agreed there was a lack of evidence in support of the use of light therapy for people with dementia and sleep problems. The benefits of multicomponent interventions, including NITE-AD, were considered and the committee agreed that although the participants showed an increase in sleep at night-time and a reduction in awake-time at night, the importance of these improvements was hard to judge in the absence of data on the effect on participant or carer quality of life. Since the evidence suggested that light therapy alone was ineffective at increasing sleep the committee attributed the changes seen to the other interventions included in the programme, namely improved sleep hygiene and daily exercise. The discussion expanded to include the reduction in day-time sleep associated with individualised social activities, which despite not being associated with a significant increase in night-time sleep could have an important effect on people’s quality of life by enriching their environment. The committee commented on the value of improved sleep hygiene, exposing people to daylight, physical and other pleasurable activities on general health and wellbeing of people with dementia. The committee agreed the positive results of the 3 trials looking at multicomponent interventions justified a recommendation in favour of an intervention involving sleep hygiene, daylight exposure and exercise, but in the absence of robust data on quality of life felt this recommendation should be kept at the “consider” level. Agitation, aggression and apathy The committee recognised there was some overlap in symptoms experienced by people living with dementia; managing symptoms is not necessarily discrete. Overall, the committee agreed that staff training studies demonstrated the most positive findings. The committee considered the relevance of training implementation. It noted that the health technology assessment presented for Livingston (2014) had demonstrated similar findings and consequently the committee concluded that the focus for implementation should rest upon care providers where group training sessions could be offered. It recognised that the evidence reported in Deudon (2009) suggested that supporting and mentoring staff could have positive effects. For this reason the committee agreed it was appropriate to incorporate specific aspects of that reported intervention within a recommendation. Specifically, the committee recognised the benefit of face to face interventions rather than e-learning interventions. It agreed that it was important for initial sessions to be followed by on the job support sessions, focusing upon specific content. In addition, the committee considered the evidence for ginkgo biloba in treating symptoms of agitation in people with dementia. It acknowledged that the pooled outcomes from 4 trials demonstrated positive outcomes for treating behavioural and psychological symptoms of dementia but was also mindful that evidence from non-dementia specific populations had observed effects from drug interactions. The committee also noted that ginkgo biloba is on a list of items that currently cannot be prescribed in primary care, and therefore agreed it was not appropriate to make any recommendations on its use. |
| Trade-off between net health benefits and resource use | Depression and anxiety No economic evidence was identified for non-pharmacological management of depression and anxiety. However, the committee agreed that the recommendation made was broadly similar to that in the NICE guideline for depression, and therefore it was unlikely there would be significantly higher resource use in this group. Managing distress The committee noted there was no specific evidence available on the cost-effectiveness of non-pharmacological interventions for managing distress. However, it did note the evidence from the 2014 Livingston HTA report which demonstrated that successful non-pharmacological interventions for managing non-cognitive symptoms could be cost-saving, due to the reductions in subsequent treatment costs for those receiving early interventions. The committee agreed that this recent HTA report represented the best quality economic evidence available, and supported the recommendation for the first line use of non-pharmacological management. Agitation and aggression The committee noted that the Grip on Challenging Care programme (GRIP) (trialled by Zwijsen in 2011), a non-pharmacological treatment strategy for patients with dementia who display symptoms of agitation and aggression, resulted in a loss of QALYs, despite incurring a small but modest cost for the treatment. GRIP is therefore a dominated strategy. The committee also took note of the EVIDEM-E study and concluded that evidence for exercise for behavioural and psychological symptoms of dementia did not show a significant difference in terms of costs or benefits and were therefore unable to recommend it. Sleep problems The potential cost of a programme similar to NITE-AD was discussed by the committee with concern being raised about the cost of multiple sessions with a geropsychologist. It was suggested that another suitably trained person could deliver these sessions instead and at less cost to the health system. In addition, the committee noted that the study by Alessi 2005, which contained a similar multicomponent intervention but without the same extensive input from a geropsychologist, appeared to be equally effective, and was therefore confident that such an intervention could be delivered without imposing a large additional resource burden. |
| Quality of evidence | Depression and anxiety The committee noted that the trials included in the meta-analysis of psychological interventions were heterogeneous, both in terms of the entry criteria into the trial and the interventions studied. Unfortunately, the sample sizes of the individual trials were small, so it was not possible to identify which individual interventions (e.g. CBT, counselling, psychodynamic interpersonal therapy) were likely to have the most robust effects, and therefore the committee agreed that only a general recommendation for psychological treatments was appropriate. The committee agreed it was appropriate to make a research recommendation about the most effective psychological treatments for anxiety and depression, in order to identify which of this class of interventions is most appropriate to offer to people living with dementia. Managing distress The committee noted that the evidence on using enhanced psychosocial care to reduce antipsychotic prescribing rates came from a single study. Therefore, whilst it was confident to recommend that this should form part of the training given to staff to manage anxiety, it did not feel that it was appropriate to recommend any specific form these interventions should take based on this single study. Sleep problems The committee commented that the short time frame of 2 days used in the slow-stroke back massage pilot study (Harris 2012) was probably insufficient to determine effects on sleep problems. The committee agreed that it was difficult to fully disentangle the effects of the individual components of the NITE-AD intervention, and therefore it was not possible to make recommendations about which parts of the intervention were the most important. The committee was concerned that patients with sleep disordered breathing in the Chong 2005 study were not generally representative of people with dementia and a sleep problem, and that the use of a mask in people with dementia would be both problematic and potentially distressing. |
| Other considerations | The committee agreed that one of the factors leading to sleep problems for people with dementia is likely to be a lack of stimulation during the day. This can lead to day-time sleepiness and therefore affect sleep patterns at night. The committee therefore agreed that the non-pharmacological interventions considered elsewhere in this guideline for the improvement of function and wellbeing in people which dementia would be likely to also have an impact on sleep problems for some people. The committee noted that only very limited evidence as found on managing non-cognitive symptoms in people with Parkinson’s disease dementia or dementia with Lewy bodies, and therefore agreed it was appropriate to cross-refer to the advice in the NICE Parkinson’s disease guideline. However, the committee noted these interventions may need to be modified to be appropriate or a population of people living with dementia, and agreed it was important to highlight this within the recommendation. |
14.1.6. Recommendations
Agitation, aggression, distress and psychosis
- 91.
Before starting non-pharmacological or pharmacological treatment for distress in people living with dementia, conduct a structured assessment to:
- explore possible reasons for the person’s distress and
- check for and address clinical or environmental causes (for example pain, delirium or inappropriate care).
- 92.
As initial and ongoing management, offer psychosocial and environmental interventions to reduce distress in people living with dementia.
- 93.
Only offer antipsychoticsh,i for people living with dementia who are either:
- at risk of harming themselves or others or
- experiencing agitation, hallucinations or delusions that are causing them severe distress.
- 94.
Be aware that for people with dementia with Lewy bodies or Parkinson’s disease dementia, antipsychotics can worsen the motor features of the condition, and in some cases cause severe antipsychotic sensitivity reactions. For more guidance, see the advice on managing delusions and hallucinations in the NICE guideline on Parkinson’s disease. Be aware that interventions may need to be modified for people living with dementia
- 95.
Before starting antipsychotics, discuss the benefits and harms with the person and their family members or carers (as appropriate). Consider using a decision aid to support this discussion.
- 96.
When using antipsychotics:
- use the lowest effective dose and use them for the shortest possible time
- reassess the person at least every 6 weeks, to check whether they still need medication.
- 97.
Stop treatment with antipsychotics:
- the person is not getting a clear ongoing benefit from taking them and
- after discussion with the person taking them and their family members or carers (as appropriate).
- 98.
Ensure that people living with dementia can continue to access psychosocial and environmental interventions for distress while they are taking antipsychotics and after they have stopped taking them.
- 99.
For people living with dementia who experience agitation or aggression, offer personalised activities to promote engagement, pleasure and interest.
- 100.
Do not offer valproate to manage agitation or aggression in people living with dementia, unless it is indicated for another condition.j
Depression and anxiety
- 101.
For people living with mild to moderate dementia who have mild to moderate depression and/or anxiety, consider psychological treatments.
- 102.
Do not routinely offer antidepressants to manage mild to moderate depression in people living with mild to moderate dementia, unless they are indicated for a pre-existing severe mental health condition.
Sleep problems
- 103.
Do not offer melatonin to manage insomnia in people living with Alzheimer’s disease.
- 104.
For people living with dementia who have sleep problems, consider a personalised multicomponent sleep management approach that includes sleep hygiene education, exposure to daylight, exercise and personalised activities.
Parkinson’s disease dementia and dementia with Lewy bodies
- 105.
For guidance on the management of Parkinson’s disease symptoms in people with Parkinson’s disease dementia and Dementia with Lewy bodies, see the NICE guideline on Parkinson’s disease. Be aware these interventions may need to be modified for people living with dementia.
14.1.7. Research recommendations
- 13.
What are the most effective psychological treatments for managing depression or anxiety in people living with dementia at each stage of the condition?
- 14.
What is the effectiveness and cost-effectiveness of dextromethorphan-quinidine for managing agitation in people living with dementia?
- 15.
What is the effectiveness and cost-effectiveness of choline alphoscerate for managing apathy in people living with dementia?
- 16.
What is the effectiveness of pharmacological treatments for sleep problems in people who have not responded to non-pharmacological management?
For more details on the research recommendations made, and the rationale behind them, see appendix L.
Footnotes
- h
The MHRA (2012) has given advice for health and social care professionals on prescribing antipsychotics to people living with dementia to treat the behavioural and psychological symptoms of dementia.
- i
At the time of publication (June 2018), the only antipsychotics with a UK marketing authorisation for this indication were risperidone and haloperidol. The marketing authorisation for risperidone only covers short-term treatment (up to 6 weeks) of persistent aggression in people with moderate to severe Alzheimer’s disease unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others. The marketing authorisation for haloperidol only covers treatment of persistent aggression and psychotic symptoms in people with moderate to severe Alzheimer’s dementia and vascular dementia when nonpharmacological treatments have failed and when there is a risk of harm to self or others. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented. See the General Medical Council’s Prescribing guidance: prescribing unlicensed medicines for further information.
- j
If relevant, follow MHRA advice that valproate medicines are contraindicated in women and girls of childbearing potential unless a Pregnancy Prevention Programme is in place.
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