A 24-month, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy, Safety, Tolerability, Biomarker, and Pharmacokinetic Study of AZD3293 in Early Alzheimer's Disease (The AMARANTH Study)

Amaranth [NCT02245737]

Description: The purpose of this study is to assess the efficacy and safety of LY3314814 compared with placebo administered for 104 weeks in the treatment of early Alzheimer´s disease. The study will test the hypothesis that LY3314814 is a disease-modifying treatment for participants with early Alzheimer´s disease, defined as the continuum of participants with mild cognitive impairment (MCI) due to Alzheimer´s disease and participants diagnosed with mild dementia of the Alzheimer´s type, as measured by change from baseline in the Clinical Dementia Rating-Sum of Boxes score at week 104 in each of the 2 LY3314814 treatment groups compared with placebo.
Drug: LY3314814; Drug: Placebo

Primary Investigator: Keyes

Drug/Device Information
To evaluate the potential of AZD3293 to be a disease modifying treatment for early AD by providing evidence of the compound’s safety, tolerability, and impact on cognitive decline and on biomarkers
AZD3293 is a brain-permeable inhibitor of human Beta-site amyloid precursor protein-cleaving enzyme 1 (BACE1/ß-secretase)
Randomization to AZD3293 20 mg, AZD3293 50 mg, or placebo in a ratio of 1:1:1
Duration of treatment - The overall study duration will be approximately 118 weeks
Eli Lilly and Company