NCT03131453

A Study of CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease

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).

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,145 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 60 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Alzheimers Disease

Interventions

Type	Name	Description
DRUG	CNP520 50mg	50 mg capsule
DRUG	CNP520 15mg	15 mg capsule
OTHER	Matching placebo	Matching placebo for 15 and 50 mg capsules

Timeline

• Start date: 2017-08-03
• Primary completion: 2020-03-26
• Completion: 2020-03-26
• First posted: 2017-04-27
• Last updated: 2021-08-05
• Results posted: 2021-08-05

Locations

194 sites across 25 countries: United States, Argentina, Australia, Belgium, Canada, Chile, China, Finland, France, Germany, Iceland, Israel, Italy, Japan, Mexico, Netherlands, Portugal, Puerto Rico, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study