A Long Term Safety Trial of MK-8931 in AD (EPOCH)
Research type
Research Study
Full title
A Parallel-Group, Double Blind Long Term Safety Trial of MK-8931 in Subjects with Alzheimer's Disease. (Protocol No. MK-8931-017- 12) (also known as SCH 900931, P07738)
IRAS ID
180061
Contact name
Roger Bullock
Contact email
Sponsor organisation
Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2015-000616-18
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Alzheimer's Disease (AD) is a slowly developing neurodegenerative disease that is the leading cause of dementia world-wide. The current treatments only moderately improve symptoms but they do not alter disease progression.
AD is characterised by the formation of amyloid deposits (plaques) in the brain, followed by neurofibrillary tangles and neuronal degeneration. The amyloid deposits are formed by Amyloid-β ( β) peptides. These peptides result from the division of the amyloid precursor protein (APP) by three distinct proteins, one of which is BACE1.
MK8931 is a potent BACE1 inhibitor. We hope that it may reduce the Aβ production and therefore potentially slow progression in subjects with mild to moderate AD.This long term safety study is an open label extension for patients who have completed the initial 78 week blinded trial. Patients who complete the main study may choose to enter this long term safety study, where patients who were receiving active MK8931 will continue to do so, patients who were receiving placebo will begin treatment with 40mg dose of the active drug. The duration of this trial will be determined by the ongoing approval of the regulatory agency who will review safety data initially after 2 years. The study will end when the program is terminated or the drug becomes commercially available which is expected to be approximately 5 years.
The study will involve a caregiver, 3 clinic visits in the first year with annual visits thereafter plus phone calls over a maximum of 5 years.
The study is funded by Merck Sharp & Dohme Limited
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
15/NE/0173
Date of REC Opinion
2 Jun 2015
REC opinion
Unfavourable Opinion