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

Last updated: July 7, 2021
Sponsor: Novartis Pharmaceuticals
Overall Status: Terminated

Phase

2/3

Condition

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT02565511
CAPI015A2201J
1UF1AG046150-01
2015-002715-15
  • Ages 60-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Consented to receive disclosure of their risk estimates to develop clinical symptomsof AD based on their APOE genotype.
  • Male or female, age 60 to 75 years inclusive. Females were to be post-menopausal.
  • Mini-Mental State Examination (MMSE) total score ≥ 24 and cognitively unimpaired asevaluated by memory tests
  • Homozygous APOE4 genotype.
  • Participant willing to have a study partner.

Exclusion

Key Exclusion Criteria:

  • Any disability that prevented the participant from completing all study requirements.
  • Current medical or neurological condition that could have impacted cognition orperformance on cognitive assessments.
  • Advanced, severe progressive or unstable disease that may have interfered with thesafety, tolerability and study assessments, or put the participant at special risk.
  • History of malignancy of any organ system, treated or untreated, within 60 monthsprior to screening.
  • History of hypersensitivity to any of the investigational drugs or their excipients /adjuvant or to drugs of similar chemical classes.
  • Indication or on current treatment with ChEIs and/or another AD treatment (e.g.memantine).
  • Contraindication or intolerance to MRI or PET investigations (with fluorinated radioligands).
  • Brain MRI results showing findings unrelated to AD that, in the opinion of theInvestigator could have been a leading cause to future cognitive decline, pose a riskto the participant, or prevent a satisfactory MRI assessment for safety monitoring.
  • Suicidal Ideation in the past six months or Suicidal Behavior in the past two years,prior to screening.
  • A positive drug screen at Screening, if, in the Investigator's opinion, this was dueto drug abuse.
  • Significantly abnormal laboratory results at Screening, or infection not as a resultof a temporary condition.
  • Current clinically significant ECG findings. For Cohort - I only: Participants withprevious organ transplantation or stem cell transplantation, or indication fortreatment with anti-coagulants. For Cohort - II only: Participants with depigmenting or hypopigmenting conditions (e.g.albinism vitiligo) or active / history of chronic urticarial in the past year.

Study Design

Total Participants: 480
Study Start date:
November 30, 2015
Estimated Completion Date:
April 30, 2020

Study 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.

Connect with a study center

  • Novartis Investigative Site

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Novartis Investigative Site

    Heidelberg Heights, Victoria 3081
    Australia

    Site Not Available

  • Novartis Investigative Site

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Novartis Investigative Site

    Gent, 9000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Leuven, 3000
    Belgium

    Site Not Available

  • Okanagan Clinical Trials

    Kelowna, British Columbia V1Y1Z9
    Canada

    Site Not Available

  • Novartis Investigative Site

    Kentville, Nova Scota B4N 4K9
    Canada

    Site Not Available

  • Novartis Investigative Site

    Halifax, Nova Scotia B3S 1M7
    Canada

    Site Not Available

  • Novartis Investigative Site

    London, Ontario N6C 0A7
    Canada

    Site Not Available

  • Novartis Investigative Site

    Ottawa, Ontario K1G 1Z3
    Canada

    Site Not Available

  • Novartis Investigative Site

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • The Centre for Memory and Aging

    Toronto, Ontario M4G 3E8
    Canada

    Site Not Available

  • Toronto Memory Program

    Toronto, Ontario M3B 2S7
    Canada

    Site Not Available

  • The Centre for Memory and Aging

    Totonto, Ontario M4G 3E8
    Canada

    Site Not Available

  • Novartis Investigative Site

    Gatineau, Quebec J8T 8J1
    Canada

    Site Not Available

  • Novartis Investigative Site

    Montreal, Quebec H3A 2BA
    Canada

    Site Not Available

  • Novartis Investigative Site

    Sherbrooke, Quebec J1H 5N4
    Canada

    Site Not Available

  • Novartis Investigative Site

    Quebec, G1J 1Z4
    Canada

    Site Not Available

  • Novartis Investigative Site

    Turku, 20520
    Finland

    Site Not Available

  • Novartis Investigative Site

    Bayreuth, 95445
    Germany

    Site Not Available

  • Novartis Investigative Site

    Berlin, 13353
    Germany

    Site Not Available

  • Novartis Investigative Site

    Boblingen, 71032
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bochum, 44791
    Germany

    Site Not Available

  • Novartis Investigative Site

    Gottingen, 37075
    Germany

    Site Not Available

  • Novartis Investigative Site

    Halle, 06120
    Germany

    Site Not Available

  • Novartis Investigative Site

    Kiel, 24105
    Germany

    Site Not Available

  • Novartis Investigative Site

    Koeln, 50937
    Germany

    Site Not Available

  • Novartis Investigative Site

    Leipzig, 04107
    Germany

    Site Not Available

  • Novartis Investigative Site

    Mannheim, 68159
    Germany

    Site Not Available

  • Novartis Investigative Site

    Münster, 48149
    Germany

    Site Not Available

  • Novartis Investigative Site

    Nuernberg, 90402
    Germany

    Site Not Available

  • Novartis Investigative Site

    Siegen, 57076
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ulm, 89073
    Germany

    Site Not Available

  • Novartis Investigative Site

    Wenzenbach, 93173
    Germany

    Site Not Available

  • Novartis Investigative Site

    Amsterdam, 1081 GN
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Terrassa, Barcelona 08221
    Spain

    Site Not Available

  • Novartis Investigative Site

    Pozuelo de Alarcon, Madrid 28223
    Spain

    Site Not Available

  • Novartis Investigative Site

    Barcelona, 08014
    Spain

    Site Not Available

  • Novartis Investigative Site

    Donostia-San Sebastian, 20009
    Spain

    Site Not Available

  • Novartis Investigative Site

    Basel, CH 4002
    Switzerland

    Site Not Available

  • Novartis Investigative Site

    Lausanne, CH-1011
    Switzerland

    Site Not Available

  • Novartis Investigative Site

    Westbruy On Trym, Bristol BS10 5NB
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Exeter, Devon EX2 5DW
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Plymouth, Devon PL6 8BT
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Guildford, Surrey GU27YD
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Avon, BA1 3NG
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Birmingham, B16 8QQ
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Dundee, DD1 9SY
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Glasgow, G20 0XA
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    London, W2 1PG
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Banner Alzheimer's Institute

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Novartis Investigative Site

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Novartis Investigative Site

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • Banner Sun City Research Institute

    Sun City, Arizona 85351
    United States

    Site Not Available

  • ATP Clinical Research, Inc.

    Costa Mesa, California 92626
    United States

    Site Not Available

  • Irvine Center for Clinical Research

    Irvine, California 92614
    United States

    Site Not Available

  • University of Southern California Keck School of Medicine Alzheimer Disease Research Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • Novartis Investigative Site

    Palo Alto, California 94304
    United States

    Site Not Available

  • Novartis Investigative Site

    San Diego, California 92103
    United States

    Site Not Available

  • Syrentis Clinical Research

    Santa Ana, California 92705
    United States

    Site Not Available

  • Novartis Investigative Site

    Sebastopol, California 95472
    United States

    Site Not Available

  • California Neuroscience Research Medical Group, Inc.

    Sherman Oaks, California 91316
    United States

    Site Not Available

  • Novartis Investigative Site

    Temecula, California 92591
    United States

    Site Not Available

  • Novartis Investigative Site

    Basalt, Colorado 81621
    United States

    Site Not Available

  • Yale University Alzheimer's Disease Research Unit

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • New England Institute for Clinical Research

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • Novartis Investigative Site

    District of Columbia, District of Columbia 20057
    United States

    Site Not Available

  • Georgetown University

    Washington, District of Columbia 20057
    United States

    Site Not Available

  • Novartis Investigative Site

    Washington, District of Columbia 20059
    United States

    Site Not Available

  • Georgetown University

    Washington, D.C., District of Columbia 20057
    United States

    Site Not Available

  • JEM Research Institute

    Atlantis, Florida 33462-6608
    United States

    Site Not Available

  • Florida Atlantic University, Clinical Translational Research Unit

    Boca Raton, Florida 33431
    United States

    Site Not Available

  • Brain Matters Research

    Delray Beach, Florida 33445
    United States

    Site Not Available

  • Novartis Investigative Site

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Meridien Research

    Maitland, Florida 32751
    United States

    Site Not Available

  • Merritt Island Medical Research

    Merritt Island, Florida 32952
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Mount Sinai Medical Center - The Wien Center

    Miami Beach, Florida 33140
    United States

    Site Not Available

  • Compass Research

    Orlando, Florida 32812
    United States

    Site Not Available

  • Novartis Investigative Site

    Orlando, Florida 32806
    United States

    Site Not Available

  • Progressive Medical Research

    Port Orange, Florida 32127
    United States

    Site Not Available

  • USF Health Byrd Alzheimer's Institute

    Tampa, Florida 33613
    United States

    Site Not Available

  • Compass Research

    The Villages, Florida 32162
    United States

    Site Not Available

  • Novartis Investigative Site

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Medical Research & Health Education Foundation, Inc.

    Columbus, Georgia 31909
    United States

    Site Not Available

  • NeuroStudies

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Advanced Clinical Research

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Great Lakes Clinical Trials

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • University of Kansas Alzheimer's Disease Center

    Fairway, Kansas 66205
    United States

    Site Not Available

  • Via Christi Research

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Sanders Brown Center on Aging, University of Kentucky

    Lexington, Kentucky 40504
    United States

    Site Not Available

  • Novartis Investigative Site

    Bangor, Maine 04401
    United States

    Site Not Available

  • Novartis Investigative Site

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • Novartis Investigative Site

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Novartis Investigative Site

    Kalamazoo, Michigan 49008
    United States

    Site Not Available

  • Novartis Investigative Site

    Saint Paul, Minnesota 55130
    United States

    Site Not Available

  • Novartis Investigative Site

    Saint Louis, Missouri 63104
    United States

    Site Not Available

  • Memory Disorders Program, Department of Neurological Sciences, University of Nebraska Medical Center

    Omaha, Nebraska 68198-7680
    United States

    Site Not Available

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Memory Enhancement Center

    Eatontown, New Jersey 07724
    United States

    Site Not Available

  • The Memory Center of Northeastern New York

    Latham, New York 12110
    United States

    Site Not Available

  • NYU Langone Medical Center

    New York, New York 10016
    United States

    Site Not Available

  • The Nathan S. Kline Institute

    Orangeburg, New York 10962
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14620
    United States

    Site Not Available

  • Alzheimer's Memory Center

    Charlotte, North Carolina 28270
    United States

    Site Not Available

  • Duke University Medical center

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Triad Clinical Trials, LLC

    Greensboro, North Carolina 27410
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center / Case Western Reserve University

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Novartis Investigative Site

    Centerville, Ohio 45459
    United States

    Site Not Available

  • Novartis Investigative Site

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Novartis Investigative Site

    Columbus, Ohio 43210
    United States

    Site Not Available

  • IPS Research Company

    Oklahoma City, Oklahoma 73103
    United States

    Site Not Available

  • Novartis Investigative Site

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Memory Health Center at Summit Research Network

    Portland, Oregon 97210
    United States

    Site Not Available

  • The Clinical Trial Center, LLC

    Jenkintown, Pennsylvania 19046
    United States

    Site Not Available

  • Novartis Investigative Site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Abington Neurological Associates

    Willow Grove, Pennsylvania 19090
    United States

    Site Not Available

  • Butler Hospital Memory and Aging Program

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • Roper St. Francis - CBRI

    Charleston, South Carolina 29401
    United States

    Site Not Available

  • Novartis Investigative Site

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • CNS Healthcare

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Novartis Investigative Site

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Senior Adults Specialty Research

    Austin, Texas 78757
    United States

    Site Not Available

  • Kerwin Research Center & Memory Care

    Dallas, Texas 75231
    United States

    Site Not Available

  • Clinical Trial Network

    Houston, Texas 77074
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas Health Science Center, Houston

    Houston, Texas 77054
    United States

    Site Not Available

  • The Memory Clinic

    Bennington, Vermont 05201
    United States

    Site Not Available

  • Novartis Investigative Site

    Spokane, Washington 99204
    United States

    Site Not Available

  • Universal Research Group

    Tacoma, Washington 98405
    United States

    Site Not Available

  • The Medical College of WI

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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