CompletedPhase 2 / PHASE3

Study Evaluating the Safety, Tolerability, and Efficacy of Lecozotan SR in Outpatients With Alzheimer's Disease

A 6-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 Treated With a Cholinesterase Inhibitor

Lead sponsor

Pfizer

Asset

Lecozotan

Listed sites

Recruiting sites

Enrollment

250

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required

Primary endpoint

•All events and physical and neurological function and score change

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 ID3098B1-203, 3098B1-204

NCT IDNCT00277810

Timeline

Milestones

Study first posted2006-01-16estimated

Study start2006-03 (month precision)

Primary completion2008-06actual (month precision)

Study completion2008-06actual (month precision)

Last update posted2020-07-07actual

Assets

Drug assets

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 Alzheimer's disease

•Current use of cholinesterase inhibitor

•Able to give signed and dated informed consent and lives with appropriate caregiver at home or in community dwelling with caregiver accompanying patient to all visits and visiting patient at least daily for duration of the study

Exclusion criteria

•Significant neurological disease other than AD

•Diagnosis of major depression

•History of stroke or other heart disease

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.

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

All events and physical and neurological function and score change from baseline to 24 weeks in ratings for cognitive and global function scales

Time frame:6 mo extension study: week 24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Score change from baseline to 24 weeks on functional and behavioral scales

Time frame:week 24

change from baseline, improvement

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.