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Bond M, Rogers G, Peters J, et al. The Effectiveness and Cost-Effectiveness of Donepezil, Galantamine, Rivastigmine and Memantine for the Treatment of Alzheimer's Disease (Review of Technology Appraisal No. 111): A Systematic Review and Economic Model. Southampton (UK): NIHR Journals Library; 2012 Apr. (Health Technology Assessment, No. 16.21.)

Cover of The Effectiveness and Cost-Effectiveness of Donepezil, Galantamine, Rivastigmine and Memantine for the Treatment of Alzheimer's Disease (Review of Technology Appraisal No. 111): A Systematic Review and Economic Model

The Effectiveness and Cost-Effectiveness of Donepezil, Galantamine, Rivastigmine and Memantine for the Treatment of Alzheimer's Disease (Review of Technology Appraisal No. 111): A Systematic Review and Economic Model.

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Appendix 11Ongoing trials

Register/ identifier number (if not available then study ID cited)Sponsor/ collaboratorsTrial nameInvestigatorCountryEstablished/ anticipated sample sizePhaseStatus
ISRCTH96337233West Midlands NHS Research & Development ExecutiveA reliable assessment of the efficacy and safety of donepezil and aspirin in Alzheimer's disease (AD2000)Professor Richard Gray (University of Birmingham Clinical Trials Unit)UK310Completed – 2004
NCT00843518Eli Lilly & CompanyTreatment for aggression and agitation in patients with Alzheimer's diseaseNot specifiedUSANot specifiedPhase IIRecruiting
NCT00035204J&JA double-blind, randomized pilot study to evaluate the effects of galantamine and donepezil on sleep and attention and gastrointestinal (GI) tolerance in patients with mild to moderate Alzheimer's diseaseNot specifiedNot specifiedNot specifiedPhase IVCompleted
NCT00523666Ludwig-Maximilians – University of MunichDiffusion tensor weighted MRI in Alzheimer's disease: prediction and mapping of symptomatic and disease modifying treatment effects of galantamine (Reminyl®)Stefan TeipelGermanyNot specifiedPhase IVRecruiting
NCT01024660AstraZenecaThe effect of cognitive function as measured by repeated cognitive measures after 12 weeks treatment with donepezilMalene JensenCanada, Peru, South Africa, Poland155NARecruiting
NCT00693004Epix Pharmaceuticals Inc.A phase II, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of PRX-03140 as monotherapy in subjects with Alzheimer's diseaseNot specifiedUS236Phase IITerminated
NCT00645190Xian-Janssen Pharmaceutical LtdA randomized, double blind, active control, flexible dose, multicentre study to evaluate galantamine HBr in the treatment of Alzheimer's disease: safety and effectiveness of an immediate-release table formulationNot specifiedNot specified215Phase IIICompleted
NCT00100334Praecis Pharmaceuticals Inc.Multiple dose safety and preliminary pharmacodynamic study of PPI-1019 in subjects with mild–moderate Alzheimer's diseaseNot specifiedUSA24Phase I/IICompleted
NCT00645190Xian-Janssen Pharmaceutical LtdA randomized, double blind, active control, flexible dose, multicenter study to evaluate galantamine HBr in the treatment of Alzheimer's disease: safety and effectiveness of an immediate-release table formulationNot specifiedNot specified215Phase IIICompleted
NCT00190021Beersheva Mental Health CenterDonepezil as add-on treatment of psychotic symptoms in patients with dementia of the Alzheimer's typeVladimir LernerIsrael80Phase IIINot yet recruiting
NCT00099242NovartisEfficacy and safety of the rivastigmine transdermal patch in patients with probable Alzheimer's diseaseNot specifiedUSA, Chile, Czech Republic, Denmark, Finland, Guatemala, Israel, Italy Korea (Republic of), Mexico, Norway, Peru, Poland, Portugal, Russian Federation, Slovakia, Sweden, Taiwan (Province of China), Venezuela1040Phase IIICompleted
NCT00096473Eisai Inc./PfizerA 24 week, multicenter, randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of donepezil hydrochloride (E2020) in patients with severe Alzheimer's disease followed by a 12 week open-label extension periodSharon Richardson, Honglan LiUSANot specifiedPhase IIICompleted
NCT00916383Teikoku Pharma USAA randomized, placebo-controlled study in elderly Alzheimer's subjects on an established and well tolerated dose of aricept to assess skin tolerability, skin irritation and adhesion with three consecutive seven-day applications of the 350 mg donepezil transdermal patch-systemNot specifiedUSA48Phase IIOngoing but not recruiting
NCT00711204Eisai Inc./PfizerA 12-week, double-blind, placebo-controlled study to evaluate the impact of donepezil hydrochloride (Aricept) on behavioral and psychological symptoms in patients with severe Alzheimer's diseaseThomas McRae (Pfizer)USA200Phase IVTerminated
NCT00478205Eisai Inc./Eisai LtdDouble-blind, parallel-group comparison of 23 mg donepezil sustained release (SR) to 10 mg donepezil immediate release (IR) in patients with moderate to severe Alzheimer's diseaseJane Yardley, Eisai LtdUSA1200Phase IIICompleted
NCT00216593Janssen Pharmaceutica NV, BelgiumTreatment of severe Alzheimer's disease in a residential home, nursing home, or geriatric residential setting: evaluation of efficacy and safety of galantamine hydrobromide in a randomised, doubleblind, placebo-controlled studyJanssen Pharmaceutica N.VS Clinical Trial Janssen Pharmaceutica N.V.Not specified415Phase IIICompleted
NCT00235716Department of Veterans Affairs/Forest Laboratories/ DSM Nutritional Products, Inc.CSP #546 – A randomised, clinical trial of vitamin E and memantine in Alzheimer's disease (TEAM-AD)Maurice Dysken (Minneapolis Veterans Affairs Medical Center)USA, Puerto Rico840Phase IIIRecruiting
NCT00216593Janssen Pharmaceutica NV, BelgiumTreatment of severe Alzheimer's disease in a residential home, nursing home, or geriatric residential setting: evaluation of efficacy and safety of galantamine hydrobromide in a randomised, double-blind, placebo-controlled studyJanssen Pharmaceutica NV

Clinical Trial Janssen Pharmaceutica NV
Not specified415Phase IIICompleted
NCT00814801Janssen Pharmaceutical KKPlacebo-controlled confirmatory study of galantamine (R113675) for Alzheimer's type dementiaJanssen Pharmaceutical KK

Clinical Trial, Study Director, Janssen Pharmaceutical KK
Not specified580Phase IIICompleted
NCT00183729National Institute of Mental Health (NIMH)Memantine for enhancement of rehabilitation efficacy and prevention of major depressive disorder in older adultsEric J. Lenze, MD (University of Pittsburgh)USA40Phase IVActive, not recruiting
ISRCTN24953404East Kent Hospitals Research and Development Committee (UK) (funded by Lundbeck Pharmaceuticals UK)A randomized, double-blind, placebo-controlled trial of memantine in the treatment of agitation in dementia (MAGD)Dr Chris Fox (Folkestone Health Centre), Dr Art Artionou (Buckland Hospital, Dover)UK154Not specifiedOngoing
ISRCTN55568578Department of Health, London (funded by Avon and Wiltshire Mental Health Partnership NHS Trust)Making evidence-based decisions using Alzheimer therapy (MEDUSA Therapy)Dr Roger Bullock, (Kingshill Research Centre, Victoria Hospital, Swindon)UK75Not specifiedCompleted
ISRCTN49545035Institute of Psychiatry (UK) [funded by Medical Research Council (UK) (grant ref: G0600989)]Donepezil and memantine IN moderate to severe Alzheimer's disease (DOMINO-AD)Professor Robert Howard (Institute of Psychiatry, London, UK)UK800Not specifiedOngoing
ISRCTN68407918Kings College London (UK) (funded by Lundbeck Pharmaceuticals Ltd)Memantine for the long term management of neuropsychiatric symptoms in Alzheimer's disease (MAIN-AD)Professor Clive Ballard (King's College, London)UK300Not specifiedOngoing
ISRCTN62185868Kings College London (UK) [funded by Medical Research Council (UK)]A randomized placebo controlled trial of a cholinesterase inhibitor in the management of agitation in dementia that is unresponsive to a psychological intervention (CALM-AD)Professor Robert Howard (Institute of Psychiatry, London, UK)UK285Not specifiedCompleted
NCT00857649H Lundbeck A/SA randomised, double-blind, parallel-group study examining the efficacy and safety of memantine in patients with moderate to severe dementia of the Alzheimer's typeDr Sauge Gauthier and Dr Nathan HermannCanada450Phase IIIOngoing, not recruiting
NCT00857233H Lundbeck A/SAn open-label extension study examining the safety and tolerability of memantine in patients with moderate to severe dementia of the Alzheimer's type having completed Study 10158Dr Sauge Gauthier and Dr Nathan HermannCanada450Phase IIIOngoing, not recruiting
NCT00862940H Lundbeck A/SA 1-year randomised, double-blind placebo-controlled study to evaluate the effects of memantine on rate of brain atrophy in patients with Alzheimer's diseaseDr David WilkinsonNot specified278Phase IVCompleted
(Lundbeck 99819)H Lundbeck A/SA long-term open-label extension study evaluating the safety and tolerability of memantine in patients with mild to moderate dementia of the Alzheimer's typeProfessor Serge BakchineNot specifiedNot specifiedPhase IIINot specified
(Lundbeck 99817)H Lundbeck A/SA double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of memantine in patients with dementia of the Alzheimer's typeDr Pei-Ning Wang, Dr Sui-Hing YanNot specifiedNot specifiedPhase IIINot specified
(Asubio IE-2101)Late phase II clinical study of sun Y7017 (memantine hydrochloride) in patients with moderately severe to severe dementia of the Alzheimer's type: evaluation of recommended dose and long-term safety (extension study for dose-finding and long-term safety)Professor Akira HommaNot specifiedNot specifiedPhase IINot specified
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NCT00624026Merz Pharmaceuticals GmbHProspective, single-arm, multicenter, open-label study to investigate the efficacy and tolerability of the once daily (OD) memantine treatmentProfessor Joerg SchulzGermany107Phase IIIbCompleted
NCT00649220Merz Pharmaceuticals GmbHProspective, single-arm, multi-centre, open-label study to investigate the potential to reduce concomitant antipsychotics use in patients with moderate to severe dementia of Alzheimer's type (DAT) treated with memantineProfessor Ralf IhlGermany27Phase IVCompleted
(MRZ 90001-AD-3001)Merz Pharmaceuticals GmbHOpen-label, single-arm, multicenter validation study of the ROSA-Scale (Relevant Outcome Scale for Alzheimer Patients) in patients with dementia of Alzheimer's type (DAT) treated with memantine over a 3-month periodProfessor Vjera HolthoffNot specifiedNot specifiedPhase IIIbNot specified
MRZ 9104Merz Pharmaceuticals GmbHMulticentre, randomised, double-blind, comparative study of the efficacy and tolerability of akatinol memantine and placebo in patients suffering from senile dementia, Alzheimer typeProfessor DerouesneNot specifiedNot specifiedPhase IINot specified
(Forest MEM-MD-03 C)Forest LaboratoriesExtension of MEM-MD-01 and MEM-MD-02 Phase C = 52 weeks openNot specifiedNot specifiedNot specifiedPhase IIINot specified
(Forest MEM-MD-03 D)Forest LaboratoriesExtension of MEM-MD-01 and MEM-MD-02 Phase D = open continuation until memantine is commercially availableNot specifiedNot specifiedNot specifiedPhase IIINot specified
(Forest MEM-MD-11 A/B)Forest LaboratoriesA long-term extension study evaluating the safety and tolerability of b.i.d. and q.d. administration of memantine in patients with mild to moderate dementia of the Alzheimer's type. Extension of MEM-MD-10. Phase A/B = 8 weeks Double-blind + 20 weeks openNot specifiedNot specifiedNot specifiedPhase IIINot specified
(Forest MEM-MD-11 C)Forest LaboratoriesExtension of MEM-MD-10. Phase C = 52 weeks openNot specifiedNot specifiedNot specifiedPhase IIINot specified
(Forest MEM-MD-11 D)Forest LaboratoriesExtension of MEM-MD-10. Phase D = open continuation until memantine is commercially availableNot specifiedNot specifiedNot specifiedPhase IIINot specified
(Forest MEM-MD-12 A)Forest LaboratoriesOpen extension of MEM-MD-12. 28 weeksNot specifiedNot specifiedNot specifiedPhase IIINot specified
(Forest MEM-MD-12 B)Forest LaboratoriesOpen extension of MEM-MD-12 A. A continuation until memantine is commercially availableNot specifiedNot specifiedNot specifiedPhase IIINot specified
(Forest MEM-MD-22)Forest LaboratoriesA randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of namenda in nursing home patients with moderate to severe Alzheimer's diseaseNot specifiedNot specifiedNot specifiedPhase IVNot specified
(Forest MEM-MD-23)Forest LaboratoriesA randomised, double-blind, placebo-controlled, evaluation of the safety and efficacy of memantine in patients with moderate to severe Alzheimer's disease with behavioral disturbancesNot specifiedNot specifiedNot specifiedPhase IIINot specified
NCT00401167Sunnybrook Health Sciences Centre/H Lundbeck A/SPhase IV – an open-label prospective study of memantine in institutionalized patients with severe Alzheimer's disease and significant behavioural and psychological symptoms of dementiaNathan Herrmann MDCanada32Phase IVCompleted
(Lundbeck 11875A)Lundbeck A/SAn open-label, post-marketing, naturalistic, multi-centre study evaluating the safety and efficacy of Ebixa (memantine) in the treatment of Chinese patients with Alzheimer's diseaseHong ZhenNot specifiedNot specifiedNot specifiedOngoing
(Lundbeck 12292A)Lundbeck A/SMemantine on aggression and agitation of AD – open-label studyXin Yu, Wang HuNot specifiedNot specifiedNot specifiedOngoing
NCT00800709Shanghai Mental Health Center/ Lundbeck A/SMemantine and changes of biological markers and brain PET imaging in Alzheimer's disease – double-blind, randomized, placebo-controlledXiao Shi FuChina26Phase IVRecruiting
(Lundbeck 12732A)Lundbeck A/SAn open-label, observational, multicentre study evaluating efficacy and safety profile of memantine in Chinese patients with Alzheimer's diseaseYinhua WangNot specifiedNot specifiedNot specifiedOngoing
(Lundbeck 13143A)Lundbeck A/SA randomised, double-blind, placebo-controlled study to investigate the improvement of language function in Chinese AD patients with memantineDantao PengNot specifiedNot specifiedNot specifiedNot yet initiated
(Lundbeck 11232)Lundbeck A/SA randomised, double-blind, placebo-controlled trial of memantine in the treatment of the agitation in Alzheimer's dementiaFoxNot specifiedNot specifiedNot specifiedOngoing
(Lundbeck 11786A)Lundbeck A/SImpact on aggressive behaviour and cognition of switching from donepezil to memantine in patients with moderate-to-severe AD

Design: open-label, pilot, observational, head-to-head
HuertasNot specifiedNot specifiedNot specifiedOngoing
(Lundbeck 10710)Lundbeck A/SMemantine effects on cortical excitability and its neurophysiological/ neuropsychological effects on AD patients in combination with AChEI: a pilot study

Design: first phase open-label, second phase partial blind
StefaniNot specifiedNot specifiedNot specifiedCompleted
(Lundbeck 10997)Lundbeck A/SBehaviour and cognition in ad patients treated with the NMDA receptor antagonist memantine: correlation with apoptotic mechanismSpalletaNot specifiedNot specifiedNot specifiedOngoing
(Lundbeck 11830A)Lundbeck A/SInvestigating the effect of treatment on neurotrophic factors by means of functional magnetic resonance imaging (FMRI) in patients with Alzheimer's disease

Design: double-blind, prospective randomised
Tamer AkerNot specifiedNot specifiedNot specifiedNot yet initiated
(MRZ 10001–0207)Merz Pharmaceuticals GmbHA randomized, double-blind, controlled trial to evaluate the efficacy and safety of an antidementive combination therapy (galantamine and memantine) in subjects with mild-to-moderate stage of probable AD (MEGA-COMBI-2)HeuserNot specifiedNot specifiedNot specifiedOngoing

NA, not assessed.

© 2012, Crown Copyright.

Included under terms of UK Non-commercial Government License.

Bookshelf ID: NBK98881

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