This study will evaluate the effect of 150 mg of MSDC-0160, taken daily for 90 days, compared to the effect of a placebo on changes in brain glucose utilization using FDG-PET and cognition in older people with mild Alzheimer's disease. Safety and tolerability of MSDC-0160 in this population will also be studied. These results will be used to design larger studies of MSDC-0160 in persons with mild Alzheimer's.
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The objective is to examine the feasibility of conducting future large-scale studies on the efficacy of MSDC-0160 in people with mild AD. Efficacy and safety will be assessed by estimating the effect size of 150 mg daily MSDC-0160 versus placebo on 3-month change in:
The study will also explore whether baseline levels of peripheral inflammatory biomarkers or genotypes, including but not limited to the apolipoprotein ε4 allele, explain the heterogeneity in the baseline level of brain glucose utilization and, in MSDC-0160 users, 3-month brain glucose utilization. Also examined will be whether changes in peripheral inflammatory biomarkers correlate with changes in 3-month brain glucose utilization in MSDC-0160 users.
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Metabolic Solutions Development Company
Jerry R. Colca, PhD
Raj C. Shah, MD
Rush Memorial University Medical Center