Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Alzheimer Disease
In brief
The study will evaluate the efficacy and safety of an investigational drug called SAM-531 at three dosage levels. Subjects will receive either one of the 3 dosage levels of SAM-531, donepezil or placebo for the first 24 weeks of the study (period I). Subjects who receive placebo for period I will be assigned to receive the highest dose of SAM-531 SAM-531 for the remaining 28 weeks of the study, while subjects who received one of the three SAM-531 dosage levels or donepezil in period I will continue with the same study drug (period II).
Key facts
- Study ID
- NCT00895895
- Run by
- Pfizer
- People needed
- 526
- Starts
- 2009-05-01
- Expected to finish
- 2011-05-01
- Last updated by the study team
- 2013-01-31
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of probable Alzheimer Disease according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Diseases and Related Disorders Association (NINCDS-ADRDA) criteria.
- Mini-Mental State Examination (MMSE) score of 12 to 24 at screening
- Rosen Modified Hachinski Ischemic score < or equal to 4 at screening.
You may not qualify if…
- Relevant neurologic disease other than Alzheimer Disease that may affect cognition or ability to complete the study.
- Current major depressive disorder or other current major psychiatric disorder.
- History of clinically evident stroke or clinically important carotid or vertebrobasilar stenosis or plaque.
- Use of prescription or nonprescription medications for cognitive enhancement (including memantine, ginkgo biloba, huperzine A, and cholinesterase inhibitors) within 3 months before the baseline visit.
Where it is running
- Pfizer Investigational Site — Phoenix, Arizona, United States
- Pfizer Investigational Site — Costa Mesa, California, United States
- Pfizer Investigational Site — Fresno, California, United States
- Pfizer Investigational Site — Garden Grove, California, United States
- Pfizer Investigational Site — Long Beach, California, United States
- Pfizer Investigational Site — Oxnard, California, United States
- Pfizer Investigational Site — Denver, Colorado, United States
- Pfizer Investigational Site — Denver, Colorado, United States
- Pfizer Investigational Site — Atlantis, Florida, United States
- Pfizer Investigational Site — Brooksville, Florida, United States
- Pfizer Investigational Site — Hallandale, Florida, United States
- Pfizer Investigational Site — Miami, Florida, United States
- Pfizer Investigational Site — Naples, Florida, United States
- Pfizer Investigational Site — Plantation, Florida, United States
- Pfizer Investigational Site — St. Petersburg, Florida, United States
- Pfizer Investigational Site — St. Petersburg, Florida, United States
- Pfizer Investigational Site — Sunrise, Florida, United States
- Pfizer Investigational Site — Tampa, Florida, United States
- Pfizer Investigational Site — West Palm Beach, Florida, United States
- Pfizer Investigational Site — Atlanta, Georgia, United States
- Pfizer Investigational Site — Elk Grove Village, Illinois, United States
- Pfizer Investigational Site — Park Ridge, Illinois, United States
- Pfizer Investigational Site — St Louis, Missouri, United States
- Pfizer Investigational Site — St Louis, Missouri, United States
- Pfizer Investigational Site — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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