Last updated on September 2018

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 two PET scans 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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Banner Alzheimer's Institute
Phoenix, AZ United States
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Mayo Clinic Arizona
Scottsdale, AZ United States
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Banner Sun City Research Institute
Sun City, AZ United States
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ATP Clinical Research, Inc.
Costa Mesa, CA United States
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Yale University Alzheimer's Disease Research Unit
New Haven, CT United States
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Mayo Clinic Jacksonville
Jacksonville, FL United States
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Medical Research & Health Education Foundation, Inc.
Columbus, GA United States
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Rush University Medical Center
Chicago, IL 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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University of Kansas Alzheimer's Disease Center
Fairway, KS United States
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Brigham & Women's Hospital Center for Alzheimer Research and Treatment
Boston, MA United States
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Rochester, MN United States
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Memory Disorders Program, Department of Neurological Sciences, University of Nebraska Medical Center
Omaha, NE United States
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Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, NV 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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University of Rochester Medical Center
Rochester, NY United States
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Alzheimer's Memory Center
Charlotte, NC United States
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Duke University Medical center
Durham, NC United States
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University Hospitals Cleveland Medical Center / Case Western Reserve University
Beachwood, OH United States
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Abington Neurological Associates
Willow Grove, PA United States
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Butler Hospital Memory and Aging Program
Providence, RI United States
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Charleston, SC United States
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Austin, TX 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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Leuven, Belgium
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Toronto Memory Program
Toronto, ON Canada
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Turku, Finland
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Amsterdam, Netherlands
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Barcelona, Spain
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Lausanne, Switzerland
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Irvine Center for Clinical Research
Irvine, CA United States
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Syrentis Clinical Research
Santa Ana, CA United States
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California Neuroscience Research Medical Group, Inc.
Sherman Oaks, 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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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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Sanders Brown Center on Aging, University of Kentucky
Lexington, KY United States
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The memory Center of Northeastern New York
Latham, NY United States
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Memory Health Center at Summit Research Network
Portland, OR United States
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Okanagan Clinical Trials
Kelowna, BC Canada
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Q&T Research Sherbrooke
Sherbrooke, QC Canada
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Basel, Switzerland
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Los Angeles, CA United States
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Boston, MA United States
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The Centre for Memory and Aging
Toronto, ON Canada
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Glasgow, United Kingdom
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Florida Atlantic University, Clinical Translational Research Unit
Boca Raton, FL United States
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Westbruy On Trym, United Kingdom
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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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USF Health Byrd Alzheimer's Institute
Tampa, FL United States
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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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Spokane, WA United States
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Avon, United Kingdom
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London, United Kingdom
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San Diego, CA United States
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Haley Dunning

New England Institute for Clinical Research
Stamford, CT United States
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Oklahoma City, OK United States
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Knoxville, TN United States
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Universal Research Group
Tacoma, WA United States
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Phoenix, AZ United States
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Progressive Medical Research
Port Orange, FL United States
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Dundee, United Kingdom
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Manchester, United Kingdom
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Mount Sinai Medical Center - The Wien Center
Miami Beach, FL United States
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Columbus, OH United States
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Darlinghurst, Australia
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Heidelberg Heights, Australia
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Donostia-San Sebastian, Spain
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Houston Methodist Hospital
Houston, TX United States
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