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Primary Care Research Network
East Midlands & South Yorkshire
Co-ordinating Centre
6th Floor, St John's House
30 East Street
Leicester LE1 6NB
E. judith.martin@emsy.nhs.uk
T. 0116 295 4080
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Studies A-Z > D > Domino AD
Donepezil and memantine in Moderate to Severe Alzheimer's Disease
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).
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 two treatments – either an active form or placebo of each of the two study drugs. All study measures will be assessed at randomisation, at six weeks (except DEMQOL-proxy), at 18 weeks (except CSRI and GHQ-12), 30 weeks (except DEMQOL-proxy) and at 52 weeks. These will be carried out at the clinical institution or in the participant's home according to the wishes of the participant.
Following the year of formal assessments, participants will then be followed up every 26 weeks for a further 208 weeks by telephone interview to establish whether, and on what date, they have entered a care institution. All participants will receive regular newsletters throughout the course of the study keeping them up to date with trial progress and a summary of the results at the end.
Primary outcome measures.
- Cognitive Function measured with the Standardised MMSE (SMMSE)
- Activities of Daily Living measured with the Bristol Activities of Daily Living scale (BADLS)