University of Wisconsin–Madison

Merck 019-A Phase III, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Clinical Trial to Study the Efficacy and Safety of MK-8931 (SCH 900931) in Subjects with Amnestic Mild Cognitive Impairment Due to Alzheimer’s Disease (Prodromal AD)

January 2015 to December 2017

The purpose of this study is to: 1)Test the safety and patient tolerability of two doses of MK-8931 in the treatment of subjects with Amnestic Mild Cognitive Impairment (aMCI) due to Alzheimer’s disease (AD). 2) Assess the effect of two doses of MK-8931 on disease progression in patients with aMCI due to AD. About 1500 patients will participate in the study. Up to 20 patents will take part in this study at the University of Wisconsin-Madison. Each patient will be in the study about 26 months. The study is expected to last 4 years. Patients will be assigned by chance to one of the following treatment groups: MK-8931 12mg once a day; MK-8931 40mg once a day; or Placebo (1 in 3 chance). The MRI will be performed during the following visits: screening, V5, V8, V10 and end of treatment. The images will be uploaded to the sponsor’s database for diagnosis. Other study procedures include ECG, lab tests, eye exam, neuro-cognitive assessment, and a PET scan.

This project led by: Sanjay Asthana, MD