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"Twenty-Four-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fixed Dose Regimens of Thalidomide and Placebo on CSF and Plasma Biomarkers in Patients With Mild to Moderate Alzheimer's Disease

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City:   Sun City
State:   Arizona
Zip Code:   85351
Conditions:   Alzheimer's Disease
Purpose:   This is a 24-week, randomized, double-blind, placebo-controlled study of the effect of thalidomide and placebo on CSF (cerebral spinal fluid) and plasma biomarkers in patients with mild to moderate Alzheimer's disease. This study will evaluate the effects of 24 weeks of treatment with Thalidomide on plasma biomarkers.
Study Summary:   A lumbar puncture will be done before treatment (baseline), and at 24 weeks to collect CSF for the quantification of biomarkers. As an exploratory effort, we will test the effects of thalidomide on the same biomarkers in the plasma and will determine if detectable changes mirror changes observed in the CSF.
Criteria:   Inclusion Criteria: - Subjects must have a screening diagnosis of Probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria. - Subjects must have a Mini-Mental State Examination (MMSE) score of 12-26 - Subject must live at home. - Must have a caregiver to participate in this study
NCT ID:   NCT01094340
Primary Contact:   Study Director
Carolyn Liebsack, BSN
Banner Sun Health Research Institute

Backup Contact:   N/A
Location Contact:   Sun City, Arizona 85351
United States

Marwan Sabbagh, MD
Phone: 623-832-6500

Site Status: Recruiting

Data Source:
Date Processed:   October 13, 2015
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