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

AstraZeneca

Status and phase: Completed; Early Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: Donepezil; Drug: Placebo to match Aricept

Study type: Interventional

Funder types: Industry

Identifiers

NCT01024660

D2285M00010

Details and patient eligibility

About

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.

Enrollment: 155 estimated patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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155 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

5 mg Donepezil (first 14 days), 10 mg Donepezil (next 70 days)

Treatment:

Drug: Donepezil

Drug: Donepezil

2

Placebo Comparator group

Treatment:

Drug: Placebo to match Aricept