An Efficacy and Safety Trial of MK-8931 in Mild to Moderate AD(EPOCH)

• Research type

  Research Study

• Full title

  A Randomised, Placebo-Controlled, Parellel-Group, Double-Blind Efficacy and Safety Trial of MK-8931 in Subjects with Mild to Moderate Alzheimer's Disease

• IRAS ID

  111232

• Contact name

  Roger Bullock

• Sponsor organisation

  Merck Sharp & Dohme Corp., a subsidary of Merck & Co., Inc

• Eudract number

  2011-003151-20

• 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-Ç? (AÇ?) 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 AÇ? production and therefore potentially slow progression in subjects with mild to moderate AD. This study will look at mild to moderate AD patients. Part of patient diagnosis will involve questionnaires. Some will be video-taped, some just audio and assessed using a central vendor to provide consistency across the various sites. There will be two cohorts. The Safety cohort will determine the most appropriate doses of MK8931 to go forward with into the Main cohort. The Safety cohort will involve 3 doses and placebo, then the Main cohort will involve two doses and placebo. The study will also assess the effects MK8931 has on 3 biomarkers associated with AD. Firstly, at volumetric brain mass using MRI, assess if there is any brain tissue loss. Secondly, if there has been a reduction in the synthesis of AÇ? which we believe reduces total amyloid load. This will be done using PET and flurinated amyloid-imaging PET ligand. Then finally we will look at the cerebrospinaflud (CSF) to measure the concentration of tau protein. Tau is the protein released when the brain cell die. We would expect to see a reduction. The study will involve a caregiver, 10-11 clinic visits plus phone calls over 78 weeks. The study is funded by Merck Sharp & Dohme Limited

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  12/NE/0410

• Date of REC Opinion

  31 Jan 2013

• REC opinion

  Further Information Favourable Opinion