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PharmacogWP3

CompletedPhase 1

Prediction of Cognitive Properties of New Drug Candidates for Neurodegenerative Diseases in Early Clinical Development

Effect of a 15-day Donepezil Treatment on Biomarkers of AD in Healthy Volunteers

Lead sponsor

University Hospital, Lille

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Age 18-30•Male

Primary endpoint

•ADAS-Cog

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 ID2010_41

Eudract number2010-023989-51

NCT IDNCT01487395

Timeline

Milestones

Study start2011-12 (month precision)

Study first posted2011-12-07estimated

Primary completion2012-12actual (month precision)

Study completion2013-12actual (month precision)

Last update posted2015-04-09estimated

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age30 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•18-30 year old male non-smoker subjects

•Subject without cognitive impairment or cognitive complaint (Moca>26, Mac Nair scale<15)

•Subject without history of brain disease (severe brain trauma, stroke, cerebral tumor,…)

•Subject without major medical or surgical history

•Subject without current chronic disease

•Subject without current cerebral disease

•Subject without vascular or metabolic risk factor

•Subject without history or current mental disease or addiction (MINI)

•Subject without lesion on MRI

•Subject without abnormal electrical activities on EEG

•Subject without use of chronic treatment or psychotropic drugs or substances

•French speaker subject and able to understand the test instructions

Exclusion criteria

•Subject with age < 18 years or > 30 years

•Subject with dementia or cognitive decline identified by Moca < 26

•Subject with history of brain disease (brain trauma, stroke, cerebral tumor,…)

•Subject with major medical or surgical history

•Subject with current chronic disease

•Subject with current cerebral disease

•Subject with vascular or metabolic risk factor

•Subject with history or current mental disease or addiction

•Subject with family history of young-onset dementia

•Subject with family history of chronic or severe neurological or mental disease (first degree relatives)

•Subject with lesion on MRI

•Subject with abnormal electrical activities on EEG

•Subject receiving a chronic treatment

•Subject using chronically or acutely psychotropic drugs or substances

•Subject with claustrophobia or contra-indication to MRI

•Subject unable to understand the test instructions

Endpoints (1)

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.

Global cognition

1 endpoint

Primary/protocol endpoint

Pharmacog battery

Time frame:15 days

ADAS-Cog

descriptive

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.