CompletedPhase 1

Study Evaluating GSI-953 in Healthy Young and Alzheimer's Patients

A Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSI-953 in Blood and Cerebrospinal Fluid, When Administered Orally to Healthy Young Subjects and Patients With Alzheimer Disease

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Asset

GSI-953

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Healthy volunteers

Primary endpoint

•We will assess the pharmacodynamics (PD) of biomarkers amyloid beta 40

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 ID3183A1-103

NCT IDNCT00479219

Timeline

Milestones

Study start2007-05 (month precision)

Study first posted2007-05-28estimated

Primary completion2007-10actual (month precision)

Study completion2007-10actual (month precision)

Last update posted2008-07-10estimated

Assets

Drug assets

GSI-953

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersAccepted

Eligibility criteria

•For Healthy Young Subjects: Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and 12 lead ECGs.

•For AD patients: Patients must be generally healthy with the exception of Alzheimer Disease. (same as above)

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.

Amyloid biomarkers

1 endpoint

Primary/protocol endpoint

We will assess the pharmacodynamics (PD) of biomarkers amyloid beta 40 and 42 in CSF, following single oral doses of GSI-953 in healthy young and Alzheimer's Patients.

Time frame:5 months

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.