Study Evaluating the Safety,Tolerability, PK and PD of SAM-531 in the Subjects With Mild to Moderate Alzheimer's Disease

Phase 2

Completed

• Conditions: Alzheimer Disease
• Interventions: Other: placebo; Drug: SAM-531

• Registration Number: NCT00481520
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The primary purpose of the study is to assess whether SAM-531, an investigational drug, is safe and well tolerated, compared with placebo (a medically inactive substance), in subjects with mild to moderate Alzheimer's disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-05-30
• Study First Submitted QC: 2007-05-30
• Study Start: 2007-06
• Study First Posted: 2007-06-01
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2008-06
• Disposition First Submitted: 2009-09-28
• Disposition First Submitted QC: 2009-09-28
• Last Update Submitted: 2009-09-28
• Disposition First Posted: 2009-09-30
• Last Update Posted: 2009-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	-
1	SAM-531	-

Primary Outcome Measures

Name	Time	Method
Routine safety and tolerability will be evaluated.	28 days

Secondary Outcome Measures

Name	Time	Method
This study will also investigate the pharmacokinetics(PK, how the drug is metabolized) and pharmacodynamics (PD, how the drug affects bodily and mental function) of SAM-531 compared to placebo.	28 days