MK-8931-019: Long Term Safety and Efficacy Trial of MK-8931
Research type
Research Study
Full title
A Parallel-Group, Double-Blind, Long Term Safety and Efficacy Trial of MK-8931 (SCH 900931) in Subjects with Amnestic Mild Cognitive Impairment Due to Alzheimer’s Disease (Prodromal AD).
IRAS ID
206867
Contact name
Craig Ritchie
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2015-002134-49
Clinicaltrials.gov Identifier
Duration of Study in the UK
years, 60 months, days
Research summary
Alzheimer’s disease (AD) is the leading cause of dementia worldwide.
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, MK8931, 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 amyloidβ. The study drug has been shown to reduce amyloidβ levels in human spinal fluid.
This study is a double-blind extension study which patients may join after completing an initial two year placebo controlled study. At the start of the main study patients will have been diagnosed with prodromal Alzheimer's Disease. All patients will receive active MK8931 in this extension.
There are several reasons for carrying out this extension study. It will not only allow access to MK-8931 for all participating patients before it is commercially available, but by extending the main study it will provide a greater understanding of the potential benefits of MK-8931. The design of the extension study will also present the opportunity to estimate the effects of delayed start of MK-8931, and to evaluate the safety and tolerability of two different doses in extended treatment of prodromal AD.
REC name
Scotland A: Adults with Incapacity only
REC reference
16/SS/0115
Date of REC Opinion
22 Jul 2016
REC opinion
Further Information Favourable Opinion