Donepezil and Memantine in Moderate to Severe Alzheimer's Disease (DOMINO-AD)
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|ClinicalTrials.gov Identifier: NCT00866060|
Recruitment Status : Unknown
Verified March 2009 by King's College London.
Recruitment status was: Recruiting
First Posted : March 20, 2009
Last Update Posted : March 20, 2009
The trial will examine whether pharmacological treatment with donepezil, memantine or combination of memantine and donepezil is any better than a placebo (dummy) treatment in people with Alzheimer's disease who have reached the moderate to severe stage of illness. Using a double blind design, where neither the investigators nor participants know who is receiving which treatment, participants will be randomly assigned to one of these four treatment groups (donepezil and memantine, memantine only, donepezil only or placebo). In order to keep both the investigators and participants blind to drug allocation a double dummy design will be necessary. This means that each participant will receive 2 treatments − either an active form or placebo of each of the 2 study drugs.
- Patients with Alzheimer's disease (AD) who continue donepezil beyond the point of transition from moderate to severe dementia continue to show significantly less decline on ratings of cognitive function and activities of daily living over the following 12 months than those discontinuing donepezil.
- Patients with AD who change to memantine therapy in place of donepezil at the point of transition from moderate to severe dementia show significantly smaller decline on ratings of cognitive function and activities of daily living over the following 12 months than those who receive placebo.
- Patients given the combination of memantine and donepezil at the point of transition from moderate to severe dementia show significant additive or synergistic benefits on measures of activities of daily living and cognitive function after 12 months compared to those patients continuing on either drug as a single treatment.
|Condition or disease||Intervention/treatment||Phase|
|Moderate to Severe Alzheimer's Disease||Drug: Memantine Drug: Donepezil Drug: Placebo donepezil Drug: Placebo memantine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Donepezil and Memantine in Moderate to Severe Alzheimer's Disease|
|Study Start Date :||February 2008|
|Estimated Primary Completion Date :||February 2012|
|Estimated Study Completion Date :||June 2013|
U.S. FDA Resources
Active Comparator: 1
10mg donepezil plus 20mg memantine
Participants in this arm will continue with their current donepezil 10mg/day regimen and immediately commence active memantine at a dose of 5mg per day, increasing in 5mg increments weekly until 20mg per day is achieved from week 4 onwards
Other Name: EbixaDrug: Donepezil
Other Name: Aricept
Placebo Comparator: 2
Placebo donepezil plus 20mg memantine
Participants in this arm will immediately commence active memantine at a dose of 5mg per day, increasing in 5mg increments weekly until 20mg per day is achieved from week 4 onwards. Donepezil dose will be reduced to 5mg daily in weeks 1 to 4 and replaced with placebo donepezil in week 5.
Other Name: EbixaDrug: Placebo donepezil
Placebo Comparator: 3
10mg donepezil plus placebo memantine
Participants in this arm will continue with their current donepezil 10mg/day regimen and immediately commence placebo memantine.
Other Name: AriceptDrug: Placebo memantine
Placebo Comparator: 4
Placebo donepezil plus placebo memantine
Participants in this arm will immediately commence placebo memantine dose escalation and will switch to donepezil 5mg daily in weeks 1 to 4, and replaced with placebo donepezil in week 5.
Drug: Placebo donepezil
Placebo donepezilDrug: Placebo memantine
- Cognitive Function measured with the Standardised MMSE (SMMSE). [ Time Frame: 4 years ]
- Activities of Daily Living measured with the Bristol Activities of Daily Living scale (BADLS). [ Time Frame: 4 years ]
- Non−cognitive dementia symptoms measured with the Neuropsychiatric Inventory (NPI) and the Cohen−Mansfield Agitation Inventory. [ Time Frame: 4 years ]
- Health−related quality of life measured with the EQ−5D (Euroqol Group 1990) and the DEMQOL−Proxy (Smith et al 2004) − a carer−rated and disease−specific measure of quality of life in dementia. [ Time Frame: 4 years ]
- Care−giver burden measured with the General Health Questionnaire. [ Time Frame: 4 years ]
- Cost effectiveness assessed through consideration of the combination of costs generated from the Client Service Receipt Inventory (CSRI) and the assessments of function and quality of life (BADLS, DEMQOL, EQ−5D). [ Time Frame: 4 years ]
- Institutionalisation defined as permanent transition from living in an independent household to a care home, NHS continuing care unit or hospital and measured with questions taken from the CSRI and telephone interviews. [ Time Frame: 4 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00866060
|Institute of Psychiatry||Recruiting|
|London, United Kingdom, SE5 8AF|
|Contact: Robert J Howard, MD 020 7848 0545 firstname.lastname@example.org|
|Principal Investigator: Robert J Howard, MD|
|Principal Investigator:||Robert J Howard, MD||Institute of Psychiatry|