Last updated on April 2019

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


Brief description of study

The purpose of this study is to test whether two investigational drugs called CAD106 and CNP520, administered separately, can 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 Study Description

This study will assess the effects of each of the two therapies given separately, both targeting amyloid, on cognition, global clinical status, and underlying pathology in participants at risk for the onset of clinical symptoms of Alzheimer's disease (AD). Cognitively unimpaired individuals with two APOE4 genes and age 60 to 75 years, inclusive, are selected as they represent a population at particularly high risk of progression to Mild Cognitive Impairment and/or dementia due to Alzheimer's disease.

The study follows a randomized, double-blind, placebo-controlled, two-cohort, parallel group design in which participants receive one of the investigational treatments or their matching placebo for at least 60 months up to a maximum of 96 months and no longer than when the target number of events for the TTE endpoint has been observed and confirmed in either cohort.

An unbalanced randomization (active: placebo) of 5:3 ratio in Cohort I (430 CAD106 :260 Placebo) and 3:2 ratio in Cohort II (390 CNP520 : 260 Placebo) will be applied. Randomization will be stratified by age group (60-64 years, 65-75 years) and region (North America/Other , Europe).

Participants who meet study entry requirements will be required to undergo at least one PET scan during the course of the study. Additional PET scans, blood and CSF collection will be voluntary. The study (also known as the Generation Study 1) is conducted as part of the Alzheimer's Prevention Initiative (API) program.

Clinical Study Identifier: NCT02565511

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ATP Clinical Research, Inc.

Costa Mesa, CA United States
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Mayo Clinic Jacksonville

Jacksonville, FL United States
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Great Lakes Clinical Trials

Chicago, IL United States
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Indiana University

Indianapolis, IN United States
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NYU Langone Medical Center

New York, NY United States
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The Nathan S. Kline Institute

Orangeburg, NY United States
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Alzheimer's Memory Center

Charlotte, NC United States
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Abington Neurological Associates

Willow Grove, PA United States
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Roper St. Francis - CBRI

Charleston, SC United States
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Clinical Trial Network

Houston, TX United States
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The Memory Clinic

Bennington, VT United States
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The Medical College of WI

Milwaukee, WI United States
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Syrentis Clinical Research

Santa Ana, CA United States
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Georgetown University

Washington, WA United States
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Brain Matters Research

Delray Beach, FL United States
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Merritt Island Medical Research

Merritt Island, FL United States
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University of Miami

Miami, FL United States
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Compass Research

Orlando, FL United States
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NeuroStudies

Decatur, GA United States
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Advanced Clinical Research

Meridian, ID United States
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Novartis Investigative Site

Los Angeles, CA United States
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Novartis Investigative Site

Westbruy On Trym, United Kingdom
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Novartis Investigative Site

Temecula, CA United States
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JEM Research Institute

Atlantis, FL United States
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Meridien Research

Maitland, FL United States
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Novartis Investigative Site

Atlanta, GA United States
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Via Christi Research

Wichita, KS United States
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Memory Enhancement Center

Eatontown, NJ United States
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Triad Clinical Trials, LLC

Greensboro, NC United States
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IPS Research Company

Oklahoma City, OK United States
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The Clinical Trial Center, LLC

Jenkintown, PA United States
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CNS Healthcare

Memphis, TN United States
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Novartis Investigative Site

Spokane, WA United States
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Novartis Investigative Site

San Diego, CA United States
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Novartis Investigative Site

Oklahoma City, OK United States
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Novartis Investigative Site

Knoxville, TN United States
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Universal Research Group

Tacoma, WA United States
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Progressive Medical Research

Port Orange, FL United States
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Novartis Investigative Site

Manchester, United Kingdom
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Novartis Investigative Site

Columbus, OH United States
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Novartis Investigative Site

Heidelberg Heights, Australia
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Novartis Investigative Site

Donostia-San Sebastian, Spain
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Houston Methodist Hospital

Houston, TX United States
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Novartis Investigative Site

Palo Alto, CA United States
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Novartis Investigative Site

Sebastopol, CA United States
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Novartis Investigative Site

Centerville, OH United States
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Novartis Investigative Site

Nashville, TN United States
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Novartis Investigative Site

Washington, WA United States
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Novartis Investigative Site

Phoenix, AZ United States
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Novartis Investigative Site

Rochester, MN United States
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Novartis Investigative Site

Pozuelo de Alarcon, Spain
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Novartis Investigative Site

Saint Paul, MN United States
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Novartis Investigative Site

Guildford, United Kingdom
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Novartis Investigative Site

Birmingham, United Kingdom
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Novartis Investigative Site

Saint Louis, MO United States
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Recruitment Status: Open


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