Gil Roth12.11.13
Merck has received an assessment from the Data Monitoring Committee (DMC) for its Phase II/III EPOCH study of MK-8931 in patients with mild to moderate Alzheimer's disease. The DMC has completed its planned interim safety analysis and recommended that the trial continue to recruit patients, with no changes to the protocol.
The DMC recommendation was made following a planned analysis of interim safety data that included a safety cohort of 200 patients treated with MK-8931 for at least three months. Merck will continue enrollment of the EPOCH study and will now begin dosing in a new Phase III study (APECS study) evaluating MK-8931 in patients with amnestic mild cognitive impairment due to Alzheimer's disease, also known as prodromal Alzheimer’s disease. MK-8931 is a novel investigational oral β-amyloid precursor protein site-cleaving enzyme (BACE) inhibitor.
EPOCH is a randomized, placebo-controlled, parallel-group, double-blind Phase II/III clinical trial to evaluate the efficacy and safety of two oral doses of MK-8931 (12 and 40 mg) administered daily versus placebo in patients with mild to moderate Alzheimer’s disease. The Phase II portion of the trial also included a 60 mg dose to evaluate safety. The trial is anticipated to enroll up to 1,960 patients. The primary efficacy outcomes of the study are the change from baseline in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score and the change from baseline in the Alzheimer's Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) score following 78 weeks of treatment.
APECS is a randomized, placebo-controlled, parallel-group, double-blind Phase III clinical trial to evaluate the efficacy and safety of MK-8931 in subjects with prodromal Alzheimer’s disease. The study is designed to enroll 1500 participants. Patients will be randomized to receive placebo, or 12 mg or 40 mg MK-8931, once daily. The primary efficacy outcome of the study is change from baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) score following 104 weeks of treatment.
The DMC recommendation was made following a planned analysis of interim safety data that included a safety cohort of 200 patients treated with MK-8931 for at least three months. Merck will continue enrollment of the EPOCH study and will now begin dosing in a new Phase III study (APECS study) evaluating MK-8931 in patients with amnestic mild cognitive impairment due to Alzheimer's disease, also known as prodromal Alzheimer’s disease. MK-8931 is a novel investigational oral β-amyloid precursor protein site-cleaving enzyme (BACE) inhibitor.
EPOCH is a randomized, placebo-controlled, parallel-group, double-blind Phase II/III clinical trial to evaluate the efficacy and safety of two oral doses of MK-8931 (12 and 40 mg) administered daily versus placebo in patients with mild to moderate Alzheimer’s disease. The Phase II portion of the trial also included a 60 mg dose to evaluate safety. The trial is anticipated to enroll up to 1,960 patients. The primary efficacy outcomes of the study are the change from baseline in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score and the change from baseline in the Alzheimer's Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) score following 78 weeks of treatment.
APECS is a randomized, placebo-controlled, parallel-group, double-blind Phase III clinical trial to evaluate the efficacy and safety of MK-8931 in subjects with prodromal Alzheimer’s disease. The study is designed to enroll 1500 participants. Patients will be randomized to receive placebo, or 12 mg or 40 mg MK-8931, once daily. The primary efficacy outcome of the study is change from baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) score following 104 weeks of treatment.
