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

Phase 1

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: GSI-953; Other: Placebo

• Registration Number: NCT00479219
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

To assess the pharmacodynamics (PD) of biomarkers amyloid beta peptide 40 and 42 (Ab40 and Ab42) in CSF, following single oral doses of GSI-953, an investigational drug, in healthy young subjects and patients with Alzheimer Disease (AD).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-25
• Study First Submitted QC: 2007-05-25
• Study First Posted: 2007-05-28
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-09
• Last Update Posted: 2008-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion 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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	GSI-953	-
B	Placebo	-

Primary Outcome Measures

Name	Time	Method
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.	5 months