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

A Randomised, Double-blind, Placebo-controlled, Parallel Design, Multicentre Study in Patients With Mild to Moderate Alzheimer's Disease to Investigate the Effect on Cognitive Function as Measured by Repeated CogState Testing in Relation to Effects on Traditional Cognitive Measures After 12 Weeks

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01024660

Enrollment

155

Registered

2009-12-03

Start date

2009-12-31

Completion date

2011-01-31

Last updated

2011-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

Patients with Mild to Moderate Alzheimer's Disease

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.

Interventions

DRUGDonepezil

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

DRUGPlacebo to match Aricept

Placebo capsule, orally, 84 days of treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

55 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Canada, Peru, Poland, South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026