CompletedPhase 2

Study Evaluating SRA-333 in Mild to Moderate Alzheimer's Disease (AD)

A Randomized, Double-blind, Placebo-controlled, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics Trial of Multiple Ascending Fixed Doses of SRA-333 in Subjects With Mild to Moderate Alzheimer's Disease.

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Asset

Lecozotan

Listed sites

Recruiting sites

Enrollment

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Safety and tolerability of multiple ascending fixed oral dose in subject

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 ID3098A1-200

NCT IDNCT00151333

Timeline

Milestones

Study start2005-02 (month precision)

Primary completion2005-04actual (month precision)

Study completion2005-04actual (month precision)

Study first posted2005-09-08estimated

Last update posted2009-09-04estimated

Assets

Drug assets

Lecozotan

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

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

•Men and postmenopausal or surgically sterile women aged from 50 to 85 inclusive.

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

Exclusion criteria

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

•Current clinically significant systemic illness which is likely to deteriorate or affect the subject's safety during the study.

Other exclusions apply

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.

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

To determine the safety and tolerability of multiple ascending fixed oral dose in subject with mild to moderate Alzheimer's Disease

descriptive

Secondary/protocol endpoint

To assess the pharmacokinetics and pharmacodynamics of multiple ascending fixed dose.

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.