Alzheimer's Disease Clinical Trial
Official title:
A 3-month Randomized, Double-Blind, Placebo-Controlled, Feasibility Study to Evaluate the Effects of MSDC-0160 on Brain Glucose Utilization, Cognition, Safety and Tolerability in Older Persons With Mild Alzheimer's Disease
This study will evaluate the effect of 150 mg MSDC-0160 taken daily for 90 days compared to the effect of placebo on changes in brain glucose utilization using FDG-PET and cognition in older persons 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 disease.
The specific objective is to examine the feasibility of conducting future large scale
studies on the efficacy of MSDC-0160 in persons with mild Alzheimer's disease. Efficacy and
safety will be assessed as follows:
1. Estimate the effect size of 150 mg daily MSDC-0160 versus placebo on 3-month change in
brain glucose utilization using FDG-PET pre-specified regions of interest analysis. The
a priori regions of interest (ROI) will include five bilateral regions: posterior
cingulate, parietal cortex (angular gyrus), lateral temporal cortex, medial temporal
cortex, and anterior cingulate-medial frontal cortex.
2. Estimate the effect size of MSDC-0160 versus placebo on 3-month change in brain glucose
utilization, using FDG-PET voxel-based analysis.
3. Estimate the effect size of MSDC-0160 treatment versus placebo on 3-month change in
cognitive function as determined by global cognitive function on a neuropsychological
battery of 19 tests.
4. Estimate the effect size of MSDC-0160 versus placebo on 3-month change in cognitive
function as determined by the ADAS-Cog subscale.
5. Estimate the effect of 3-months of MSDC-0160 treatment versus placebo on a 9-item
executive function scale.
6. Explore whether baseline levels of peripheral inflammatory biomarkers (HMW adiponectin,
TNFα, IL-6, hsCRP, and FFA) or genotypes including, but not limited to, the
apolipoprotein ε4 allele explain the heterogeneity in baseline level of brain glucose
utilization and, in MSDC-0160 users, 3-month brain glucose utilization.
7. Explore whether changes in peripheral inflammatory biomarkers correlate with changes in
3-month brain glucose utilization in MSDC-0160 users.
8. Investigate the safety of MSDC-0160 versus placebo using reports of early study
termination and adverse events.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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