The Effect of Cognitive Function as Measured by Repeated Cognitive Measures After 12 Weeks Treatment With Donepezil

Early Phase 1CompletedNCT01024660

AstraZeneca155 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

155

Conditions

Alzheimer's Disease

Interventions

DonepezilDRUG

5 mg capsule, orally, once daily, first 14 days of treatment

DonepezilDRUG

10 mg, orally, once daily, for remaining 70 days of treatment

Placebo to match AriceptDRUG

Placebo capsule, orally, 84 days of treatment

Eligibility

Sex: ALLMin age: 55 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (18)

Research Site

Ottawa, Ontario, Canada

Research Site

Gatineau, Quebec, Canada

Research Site

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

CogState Computerized Neurological Test Battery

Time frame: 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 Outcomes

Neuropsychological Test Battery (NTB)

Time frame: 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)

Time frame: 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)

Time frame: 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

Data from ClinicalTrials.gov

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