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

Phase 2

Completed

• Conditions: Alzheimer's Disease

• Registration Number: NCT00151333
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

To determine the safety and tolerability of multiple ascending fixed oral doses of SRA-333 in subjects with mild to moderate Alzheimer's disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Primary Completion: 2005-04
• Study Completion: 2005-04
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-03
• Last Update Posted: 2009-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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