NCT00481520
Completed
Phase 2
A Randomized, Double-blind, Placebo-controlled, Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) Trial of Multiple Ascending Fixed Doses of SAM-531 in Subjects With Mild to Moderate Alzheimer's Disease.
Wyeth is now a wholly owned subsidiary of Pfizer0 sites72 target enrollmentStarted: June 2007Last updated:
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Enrollment
- 72
- Primary Endpoint
- Routine safety and tolerability will be evaluated.
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1
Experimental
Intervention: SAM-531 (Drug)
2
Placebo Comparator
Intervention: placebo (Other)
Outcomes
Primary Outcomes
Routine safety and tolerability will be evaluated.
Time Frame: 28 days
Secondary Outcomes
- 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)
Investigators
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