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CompletedPhase EARLY_1

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

Lead sponsor

AstraZeneca

Asset

Donepezil

Listed sites

18

Recruiting sites

-

Enrollment

155

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required

Primary endpoint

•CogState Computerized Neurological Test Battery

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDD2285M00010
NCT IDNCT01024660

Timeline

Milestones

Study start2009-12 (month precision)
Study first posted2009-12-03estimated
Primary completion2011-01actual (month precision)
Study completion2011-01actual (month precision)
Last update posted2011-02-08estimated

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition
2
Other clinical outcomes
1
Other (unclassified)
1

Global cognition

2 endpoints
Secondary/protocol endpoint

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

descriptive

Secondary/protocol endpoint

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

ADAS-Cog

descriptive

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

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

descriptive

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

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

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.