CompletedPhase 2

Study Evaluating Lecozotan SR in Mild to Moderate Alzheimer's Disease (AD)

A 3-Month, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Safety, Tolerability, and Efficacy Study Of 3 Doses Of Lecozotan (SRA-333) SR In Outpatients With Mild To Moderate Alzheimer's Disease With Donepezil As Active Control.

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Assets

Donepezil / Lecozotan

Listed sites

Recruiting sites

Enrollment

229

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

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 ID3098B1-201, 3098B1-202

Secondary IDB343-1057, B343-1058Pfizer

NCT IDNCT00151398

Timeline

Milestones

Study first posted2005-09-08estimated

Study start2005-10-06actual

Primary completion2008-03-15actual

Study completion2008-03-15actual

Last update posted2022-05-06actual

Assets

Drug assets

Donepezil Lecozotan

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of probable AD according to the NINCDS-ADRDA criteria.

•Able to give informed consent. Patient' s caregiver must consent to participate in the study

Exclusion criteria

•Use of medications for cognitive enhancement within 3 months of baseline.

•Significant neurologic disease other than AD that may affect cognition.

Endpoints (2)

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

Other (unclassified)

Global cognition

1 endpoint

Primary/protocol endpoint

The primary endpoints will be the change from baseline in ADAS-Cog total score and ADCS-CGIC total score.

Time frame:weeks 12, 14, 26 and 40.

ADAS-Cog

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Secondary efficacy outcome variables include additional cognitive, functional,and behavioral measures.

Time frame:weeks 12, 14, 26 and 40.

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.