The Effect of Cognitive Function as Measured by Repeated Cognitive Measures After 12 Weeks Treatment With Donepezil
Early Phase 1
Completed
- Conditions
- Alzheimer's Disease
- Interventions
- Drug: Placebo to match Aricept
- Registration Number
- NCT01024660
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to determine if there is improvement or measurable change in cognition after only one month of treatment with donepezil when using a computerized test battery. The results at one month will be compared with the results at 3 months to evaluate this.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
Inclusion Criteria
- Clinical diagnosis of probable AD according to NINCDS-ADRDA criteria.
- The patient should live with an appropriate caregiver at home, or in a community dwelling. A caregiver should be capable of accompanying the patient to clinic visits or attending study visits in the patient's home.
- Patient and caregiver should understand, speak, and read local language.
Exclusion Criteria
- Significant neurological disease or dementia other than AD, e.g., mixed dementia, frontotemporal dementia, and Parkinson's Disease.
- Females of child bearing potential
- Impaired vision or hearing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Donepezil 5 mg Donepezil (first 14 days), 10 mg Donepezil (next 70 days) 2 Placebo to match Aricept -
- Primary Outcome Measures
Name Time Method CogState Computerized Neurological Test Battery Tl. of 25 times: 10 times between Days 3-14, 5 times between Days 36-42, 5 times between Days 64-70, four times between Days 92-97, 1 time on Day 98
- Secondary Outcome Measures
Name Time Method Neuropsychological Test Battery (NTB) Tl. of 5 times: Once between Days 1-2, Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97 Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) Tl. of 5 times: Once between Days 1-2, Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97 Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Tl. of 4 times: Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97
Trial Locations
- Locations (2)
Research Site
🇿🇦Roodepoort, South Africa
Reearch Site
🇨🇦Quebec, Canada