3-month Study of MSDC-0160 Effects on Brain Glucose Utilization, Cognition & Safety in Subjects With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): MSDC-0160; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MSDC-0160 150 mg capsules given once daily for 90 days; Placebo capsules given once daily for 90 days
Other intervention name(s): Mitoglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's disease; cognitive function; brain glucose utilization; FDG-PET