Status:
TERMINATED
Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease
Lead Sponsor:
Pfizer
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
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 place...
Detailed Description
The study was stopped (date of termination was 13April2011) due to a 6 month interim analysis: all of the 3 SAM-531 dosage levels were declared futile. There were no safety concerns.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
526 Patients enrolled
Trial Details
Trial ID
NCT00895895
Start Date
May 1 2009
End Date
May 1 2011
Last Update
January 31 2013
Active Locations (96)
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1
Pfizer Investigational Site
Phoenix, Arizona, United States, 85004
2
Pfizer Investigational Site
Phoenix, Arizona, United States, 85050
3
Pfizer Investigational Site
Costa Mesa, California, United States, 92626
4
Pfizer Investigational Site
Fresno, California, United States, 93720