Conditions: Alzheimer's Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 106
Healthy volunteers: no

Brief summary:
This study will evaluate the performance of the CogState computerized neuropsychological battery, Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) and Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) in participants with mild-to-moderate Alzheimer's disease (AD).

Detailed description:

Arms:
arm 1: There will be a 14 day period when all participants will receive placebo, followed by 5 mg donepezil, once daily for 14 days then titrated to 10 mg donepezil once daily for 70 days. Participants may then receive open-label donepezil for an additional 24 weeks. arm 2: There will be a 14 day period when all participants will receive placebo. Participants will take placebo capsules orally, once daily for 84 days. Participants may then receive open-label donepezil for an additional 24 weeks.

Interventions: intervention 1: Comparator: Placebo 5mg (run in) intervention 2: Donepezil 5 - 10 mg intervention 3: Comparator: Placebo 5-10 mg intervention 4: Donepezil 10 mg
Intervention descriptions: intervention 1: Matching placebo to donepezil - 5 mg capsules orally for 14 day run in prior to randomization. intervention 2: Donepezil 1 capsule (5 mg) orally, once daily for 14 days.

Donepezil 2 capsules (total 10 mg) once daily for 70 days (days 15-84). intervention 3: Matching placebo to donepezil, 1 capsule (5 mg) orally, once daily for 14 days.

Matching placebo to donepezil 2 capsules (total 10 mg) once daily for 70 days (days 15-84). intervention 4: Donepezil 2 capsules (total 10 mg) orally, once daily for 24 weeks, from day 85 (optional).

Protocol document: