A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CNP520 in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease (AD).
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CNP520 in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease (AD).
The purpose of this study is to determine the effects of CNP520 on cognition, global clinical status, and underlying AD pathology, as well as the safety of CNP520, in people at risk for the onset of clinical symptoms of AD based on their age, APOE genotype and elevated amyloid.
This trial was a randomized, double-blind, placebo-controlled, parallel group, adaptive design with variable treatment duration planned in cognitively unimpaired participants aged 60 to 75 years, with at least one apolipoprotein E allele (APOE4), (homozygotes (HMs) or heterozygotes (HTs)) and, if HTs, with evidence of elevated brain amyloid. The participants were randomized to either CNP520 50 mg, CNP520 15 mg or placebo a 2:1:2 ratio and was stratified based on amyloid status. The planned treatment period of 5 to 8 years was not achieved due to early study termination.
Inclusion Criteria:
Exclusion Criteria:
Sun City, Arizona 85351, United States
Colorado Springs, Colorado 80907, United States
Hollywood, Florida 33021, United States
Lake Worth, Florida 33449, United States
Elk Grove Village, Illinois 60007, United States
Farmington Hills, Michigan 48334, United States
New York, New York 10016, United States
Willow Grove, Pennsylvania 19090, United States
East Providence, Rhode Island 02914, United States
CABA, Buenos Aires C1428AQK, Argentina
Bunkyo Ku, Tokyo 113 8655, Japan
Bunkyo Ku, Tokyo 113-8431, Japan
Shinjuku-ku, Tokyo 160 8582, Japan
Kaoshiung, 83301, Taiwan