NCT02565511

A Study of CAD106 and CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease

A Randomized, Double-blind, Placebo-controlled, Two-cohort, Parallel Group Study to Evaluate the Efficacy of CAD106 and CNP520 in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease.

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 480 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 60 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to test whether two investigational drugs called CAD106 and CNP520, administered separately, could slow down the onset and progression of clinical symptoms associated with Alzheimer's disease (AD) in participants at the risk to develop clinical symptoms based on their age and genotype.

Detailed description

The study (also known as the Generation Study 1, GS1) was conducted as part of the Alzheimer's Prevention Initiative (API) program. This trial was a randomized, double-blind, placebo-controlled, parallel group, adaptive design with variable treatment duration planned in cognitively unimpaired APOE4 homozygotes (HMs) aged 60 to 75 years. Participants were enrolled into Cohort I (CAD106) or Cohort II (CNP520). The planned treatment period of 5 to 8 years was not achieved due to early study termination. The study was terminated due to unexpected changes in cognitive function, brain volume loss, and body weight loss. Cohort II (CNP520) treatment was stopped and evaluated through an off-treatment follow-up period. After the decision to terminate Cohort II of the study (CNP520), treatment with CAD106 (Cohort I) was also terminated.

Conditions

• Alzheimers Disease

Interventions

Type	Name	Description
BIOLOGICAL	CAD106 Immunotherapy	Participants will be given i.m. injections at Weeks 1, 7, 13 and quarterly i.m. injections (every 13 weeks) thereafter, until the last injection 3 month prior to completion of the Treatment Epoch.
OTHER	Placebo to CAD106	Participants will be given i.m. injections at Weeks 1, 7, 13 and quarterly i.m. injections (every 13 weeks) thereafter, until the last injection 3 month prior to completion of the Treatment Epoch.
DRUG	CNP520	CNP520 50 mg capsule p.o. for the duration of the Treatment Epoch.
OTHER	Placebo to CNP520	Placebo to CNP520 p.o. for the duration of the Treatment Epoch
OTHER	Alum	Alum was mixed with reconstituted CAD106 as adjuvant therapy to maximize the effectiveness of CAD106

Timeline

• Start date: 2015-11-30
• Primary completion: 2020-04-30
• Completion: 2020-04-30
• First posted: 2015-10-01
• Last updated: 2021-07-08
• Results posted: 2021-07-08

Locations

129 sites across 10 countries: United States, Australia, Belgium, Canada, Finland, Germany, Netherlands, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study