Merck has just initiated a Phase II/III clinical trial of its Alzheimer’s disease drug MK-8931. The trial will evaluate how effective the drug is versus a placebo among mild-to-moderate Alzheimer’s disease patients.
The MK-8931 is a novel investigational oral β-amyloid precursor protein site-cleaving enzyme (BACE) inhibitor. As a BACE inhibitor the drug inhibits the BACE enzyme which is vital in the production of amyloid β peptide. It is believed, according to the amyloid hypothesis, that the underlying cause of Alzheimer’s disease is the development of amyloid peptides which cause an accumulation of amyloid plaque deposits in the brain. Therefore, following the hypothesis, MK-8931 will work by preventing the formation of amyloid plaque deposits.
During the Phase I study Merck researchers found that MK-8931 can reduce cerebral spinal fluid (CSF) β-amyloid by more than 90 percent with no signs of dose limiting side effects.
The 78-week long placebo-controlled, randomized, parallel-group, double-blind study, called EPOCH, will monitor 200 Alzheimer’s patients and will analyze MK-8931’s effectiveness and safety before moving onto a further phase. Researchers will compare the efficacy of three different doses of MK-8931 (12, 40 and 60 mg) administered daily, versus a placebo. They will make evaluations of the drug using the Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) score and the Alzheimer’s Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score.
According to Darryle D. Schoepp, Ph.D., senior vice president and head of Neuroscience and Ophthalmology, Merck Research Laboratories:
“Merck is committed to advancing the understanding and treatment of Alzheimer’s disease,”
He adds:
“As the global health and financial burden of Alzheimer’s disease grows, innovative research is critically needed, and we need to accelerate this research wherever possible. This new study is an important step in our overall strategy to understand the potential of the BACE inhibitor mechanism and MK-8931, our lead compound, in multiple stages of Alzheimer’s disease.”
Researchers from Banner Alzheimer’s Institute in Arizona, Boston University, and the University of Antioquia found that Alzheimer’s disease could be detected over 20 years before symptoms appear.
An article published in the Journal of Pharmacology and Experimental Therapeutics showed that Alzheimer’s cognitive function improved with a brain damage drug.
Written by Joseph Nordqvist