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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00481520 |
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.
Condition | Intervention | Phase |
---|---|---|
Alzheimer Disease |
Drug: SAM-531 Other: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | 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. |
Estimated Enrollment: | 72 |
Study Start Date: | June 2007 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: SAM-531 |
2: Placebo Comparator | Other: placebo |
Ages Eligible for Study: | 50 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
United States, Florida | |
Delray Beach, Florida, United States, 33445 | |
Hallandale, Florida, United States, 33009 | |
St. Petersburg, Florida, United States, 33709 | |
United States, Georgia | |
Atlanta, Georgia, United States, 30308 | |
United States, New Jersey | |
Long Branch, New Jersey, United States, 07740 | |
United States, New York | |
New York, New York, United States, 10032 | |
United States, Vermont | |
Bennington, Vermont, United States, 05201 |
Study Director: | Medical Monitor | Wyeth |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 3193A1-2000 |
Study First Received: | May 30, 2007 |
Last Updated: | June 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00481520 |
Health Authority: | United States: Food and Drug Administration |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Neurodegenerative Diseases |
Brain Diseases Dementia Cognition Disorders Delirium |
Nervous System Diseases Tauopathies |