A Safety and Efficacy Study of MK8931 for Prodromal AD v.019-00
Research type
Research Study
Full title
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).
IRAS ID
136392
Contact name
Craig Ritchie
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,
Eudract number
2012-005542-38
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
Alzheimer’s disease (AD) is the leading cause of dementia world-wide. AD is a neurodegenerative disease which means that sufferers have a progressive loss of neuron structure and function. Current available treatments for AD are limited and generally just modestly improve symptoms without altering disease progression. Therefore, new medicines that slow or halt the progression of AD are needed.
The study drug, MK-8931, is an inhibitor of an enzyme that has an integral role in the the creation of the molecules that build up in the brain tissue of AD patients. These molecules are called amyloid-β.
The study drug has been shown to reduce amyloid-β levels in human spinal fluid.
This study will asses the safety, tolerability and efficacy of two different doses of the study drug compared against a placebo (non-active drug). The participants will be randomly allocated into treatment groups. To participate, subjects must meet the inclusion criteria which is amnestic mild cognitive impairment (aMCI) due to AD, and a positive AD biomarker result. The primary AD biomarker used is corticol amyloid load – this is the amount of amyloid-β present in the brain which is measured by a type of imaging called Positron Emission Tomography (PET).
The main objective of this study is to assess the overall clinical progression of subjects with amnestic mild cognitive impairment (aMCI) due to AD.
REC name
London - Harrow Research Ethics Committee
REC reference
13/LO/1758
Date of REC Opinion
4 Feb 2014
REC opinion
Further Information Favourable Opinion