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Recruitment has started for the SAM-531 trial, a double blind, placebo controlled, Aricept referenced trial of SAM-531 for the treatment of Alzheimer's Disease. The general outline for the trial is a 5 Arm trial (3 doses of SAM-531, 1 arm Aricept, 1 placebo) for a 12 month period. Ages Eligible for Study: | 50 Years and older | | Genders Eligible for Study: | Both | | Accepts Healthy Volunteers: | No |
- 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 criteria: - 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.
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