Twenty-four week, prospective, randomized, double-blind, placebo-controlled, parallel-group study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
974
Central Arkansas Research (CARE)
Hot Springs, Arkansas, United States
Comprehensive Neuroscience
St. Petersburg, Florida, United States
St. Francis Medical Center
Peoria, Illinois, United States
Neurological Associate of Albany PC
Albany, New York, United States
Safety: physical examinations, ECG and clinical laboratory tests. Efficacy: Vascular-Alzheimer's Disease Assessment Scale-Cognitive subscale (V-ADAS-cog) and the Clinician's Interview-Based Impression of Change-Plus Version (CIBIC-Plus).
Time frame: Parameters will be measured prior to, during and at the end of the study.
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University of Texas Mental Sciences Institute
Houston, Texas, United States