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

NCT ID: NCT02565511

Last Updated: 2021-07-08

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2020-04-30

Brief Summary

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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.

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Detailed Description

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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

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Alzheimers Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort I (CAD106)

CAD106 (450 µg) + Alum (450 µg) intra-muscular injection at Weeks 1, 7, 13 and every 13 weeks thereafter

Group Type EXPERIMENTAL

CAD106 Immunotherapy

Intervention Type BIOLOGICAL

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.

Alum

Intervention Type OTHER

Alum was mixed with reconstituted CAD106 as adjuvant therapy to maximize the effectiveness of CAD106

Cohort I (CAD106 Placebo)

Placebo to CAD106 + Alum (450 µg) intra-muscular injection at Weeks 1, 7, 13 and every 13 weeks thereafter

Group Type PLACEBO_COMPARATOR

Placebo to CAD106

Intervention Type OTHER

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.

Alum

Intervention Type OTHER

Alum was mixed with reconstituted CAD106 as adjuvant therapy to maximize the effectiveness of CAD106

Cohort II (CNP520)

CNP520 (50 mg) capsules taken orally once daily

Group Type EXPERIMENTAL

CNP520

Intervention Type DRUG

CNP520 50 mg capsule p.o. for the duration of the Treatment Epoch.

Cohort II (CNP520 Placebo)

Matching Placebo to CNP520 capsules taken orally once daily

Group Type PLACEBO_COMPARATOR

Placebo to CNP520

Intervention Type OTHER

Placebo to CNP520 p.o. for the duration of the Treatment Epoch

Interventions

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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.

Intervention Type BIOLOGICAL

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.

Intervention Type OTHER

CNP520

CNP520 50 mg capsule p.o. for the duration of the Treatment Epoch.

Intervention Type DRUG

Placebo to CNP520

Placebo to CNP520 p.o. for the duration of the Treatment Epoch

Intervention Type OTHER

Alum

Alum was mixed with reconstituted CAD106 as adjuvant therapy to maximize the effectiveness of CAD106

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Consented to receive disclosure of their risk estimates to develop clinical symptoms of 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 as evaluated by memory tests
* Homozygous APOE4 genotype.
* Participant willing to have a study partner.

Exclusion Criteria

* Any disability that prevented the participant from completing all study requirements.
* Current medical or neurological condition that could have impacted cognition or performance on cognitive assessments.
* Advanced, severe progressive or unstable disease that may have interfered with the safety, tolerability and study assessments, or put the participant at special risk.
* History of malignancy of any organ system, treated or untreated, within 60 months prior 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 radio ligands).
* Brain MRI results showing findings unrelated to AD that, in the opinion of the Investigator could have been a leading cause to future cognitive decline, pose a risk to 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 due to drug abuse.
* Significantly abnormal laboratory results at Screening, or infection not as a result of a temporary condition.
* Current clinically significant ECG findings. For Cohort - I only: Participants with previous organ transplantation or stem cell transplantation, or indication for treatment 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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Banner Alzheimer's Institute

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Amgen

INDUSTRY

Sponsor Role collaborator

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Banner Alzheimer's Institute

Phoenix, Arizona, United States

Site Status

Novartis Investigative Site

Phoenix, Arizona, United States

Site Status

Novartis Investigative Site

Scottsdale, Arizona, United States

Site Status

Banner Sun City Research Institute

Sun City, Arizona, United States

Site Status

ATP Clinical Research, Inc.

Costa Mesa, California, United States

Site Status

Irvine Center for Clinical Research

Irvine, California, United States

Site Status

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

Los Angeles, California, United States

Site Status

Novartis Investigative Site

Palo Alto, California, United States

Site Status

Novartis Investigative Site

San Diego, California, United States

Site Status

Syrentis Clinical Research

Santa Ana, California, United States

Site Status

Novartis Investigative Site

Sebastopol, California, United States

Site Status

California Neuroscience Research Medical Group, Inc.

Sherman Oaks, California, United States

Site Status

Novartis Investigative Site

Temecula, California, United States

Site Status

Novartis Investigative Site

Basalt, Colorado, United States

Site Status

Yale University Alzheimer's Disease Research Unit

New Haven, Connecticut, United States

Site Status

New England Institute for Clinical Research

Stamford, Connecticut, United States

Site Status

Georgetown University

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

Site Status

Novartis Investigative Site

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

Site Status

JEM Research Institute

Atlantis, Florida, United States

Site Status

Florida Atlantic University, Clinical Translational Research Unit

Boca Raton, Florida, United States

Site Status

Brain Matters Research

Delray Beach, Florida, United States

Site Status

Novartis Investigative Site

Jacksonville, Florida, United States

Site Status

Meridien Research

Maitland, Florida, United States

Site Status

Merritt Island Medical Research

Merritt Island, Florida, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Mount Sinai Medical Center - The Wien Center

Miami Beach, Florida, United States

Site Status

Novartis Investigative Site

Orlando, Florida, United States

Site Status

Compass Research

Orlando, Florida, United States

Site Status

Progressive Medical Research

Port Orange, Florida, United States

Site Status

USF Health Byrd Alzheimer's Institute

Tampa, Florida, United States

Site Status

Novartis Investigative Site

Atlanta, Georgia, United States

Site Status

Medical Research & Health Education Foundation, Inc.

Columbus, Georgia, United States

Site Status

NeuroStudies

Decatur, Georgia, United States

Site Status

Advanced Clinical Research

Meridian, Idaho, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Great Lakes Clinical Trials

Chicago, Illinois, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

University of Kansas Alzheimer's Disease Center

Fairway, Kansas, United States

Site Status

Via Christi Research

Wichita, Kansas, United States

Site Status

Sanders Brown Center on Aging, University of Kentucky

Lexington, Kentucky, United States

Site Status

Novartis Investigative Site

Bangor, Maine, United States

Site Status

Novartis Investigative Site

Boston, Massachusetts, United States

Site Status

Novartis Investigative Site

Boston, Massachusetts, United States

Site Status

Novartis Investigative Site

Kalamazoo, Michigan, United States

Site Status

Novartis Investigative Site

Saint Paul, Minnesota, United States

Site Status

Novartis Investigative Site

St Louis, Missouri, United States

Site Status

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

Omaha, Nebraska, United States

Site Status

Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas, Nevada, United States

Site Status

Memory Enhancement Center

Eatontown, New Jersey, United States

Site Status

The Memory Center of Northeastern New York

Latham, New York, United States

Site Status

NYU Langone Medical Center

New York, New York, United States

Site Status

The Nathan S. Kline Institute

Orangeburg, New York, United States

Site Status

University of Rochester Medical Center

Rochester, New York, United States

Site Status

Alzheimer's Memory Center

Charlotte, North Carolina, United States

Site Status

Duke University Medical center

Durham, North Carolina, United States

Site Status

Triad Clinical Trials, LLC

Greensboro, North Carolina, United States

Site Status

University Hospitals Cleveland Medical Center / Case Western Reserve University

Beachwood, Ohio, United States

Site Status

Novartis Investigative Site

Centerville, Ohio, United States

Site Status

Novartis Investigative Site

Columbus, Ohio, United States

Site Status

IPS Research Company

Oklahoma City, Oklahoma, United States

Site Status

Novartis Investigative Site

Oklahoma City, Oklahoma, United States

Site Status

Memory Health Center at Summit Research Network

Portland, Oregon, United States

Site Status

The Clinical Trial Center, LLC

Jenkintown, Pennsylvania, United States

Site Status

Novartis Investigative Site

Philadelphia, Pennsylvania, United States

Site Status

Abington Neurological Associates

Willow Grove, Pennsylvania, United States

Site Status

Butler Hospital Memory and Aging Program

Providence, Rhode Island, United States

Site Status

Roper St. Francis - CBRI

Charleston, South Carolina, United States

Site Status

Novartis Investigative Site

Knoxville, Tennessee, United States

Site Status

CNS Healthcare

Memphis, Tennessee, United States

Site Status

Novartis Investigative Site

Nashville, Tennessee, United States

Site Status

Senior Adults Specialty Research

Austin, Texas, United States

Site Status

Kerwin Research Center & Memory Care

Dallas, Texas, United States

Site Status

Houston Methodist Hospital

Houston, Texas, United States

Site Status

University of Texas Health Science Center, Houston

Houston, Texas, United States

Site Status

Clinical Trial Network

Houston, Texas, United States

Site Status

The Memory Clinic

Bennington, Vermont, United States

Site Status

Universal Research Group

Tacoma, Washington, United States

Site Status

The Medical College of WI

Milwaukee, Wisconsin, United States

Site Status

Novartis Investigative Site

Darlinghurst, New South Wales, Australia

Site Status

Novartis Investigative Site

Heidelberg Heights, Victoria, Australia

Site Status

Novartis Investigative Site

Nedlands, Western Australia, Australia

Site Status

Novartis Investigative Site

Ghent, , Belgium

Site Status

Novartis Investigative Site

Leuven, , Belgium

Site Status

Okanagan Clinical Trials

Kelowna, British Columbia, Canada

Site Status

Novartis Investigative Site

Kentville, Nova Scota, Canada

Site Status

Novartis Investigative Site

Halifax, Nova Scotia, Canada

Site Status

Novartis Investigative Site

London, Ontario, Canada

Site Status

Toronto Memory Program

Toronto, Ontario, Canada

Site Status

The Centre for Memory and Aging

Toronto, Ontario, Canada

Site Status

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status

Novartis Investigative Site

Gatineau, Quebec, Canada

Site Status

Novartis Investigative Site

Québec, Quebec, Canada

Site Status

Novartis Investigative Site

Sherbrooke, Quebec, Canada

Site Status

Novartis Investigative Site

Sherbrooke, Quebec, Canada

Site Status

Novartis Investigative Site

Turku, , Finland

Site Status

Novartis Investigative Site

Bayreuth, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Böblingen, , Germany

Site Status

Novartis Investigative Site

Cologne, , Germany

Site Status

Novartis Investigative Site

Göttingen, , Germany

Site Status

Novartis Investigative Site

Halle, , Germany

Site Status

Novartis Investigative Site

Kiel, , Germany

Site Status

Novartis Investigative Site

Leipzig, , Germany

Site Status

Novartis Investigative Site

Mannheim, , Germany

Site Status

Novartis Investigative Site

Münster, , Germany

Site Status

Novartis Investigative Site

Siegen, , Germany

Site Status

Novartis Investigative Site

Wenzenbach, , Germany

Site Status

Novartis Investigative Site

Amsterdam, , Netherlands

Site Status

Novartis Investigative Site

Terrassa, Barcelona, Spain

Site Status

Novartis Investigative Site

Pozuelo de Alarcón, Madrid, Spain

Site Status

Novartis Investigative Site

Barcelona, , Spain

Site Status

Novartis Investigative Site

Barcelona, , Spain

Site Status

Novartis Investigative Site

Donostia / San Sebastian, , Spain

Site Status

Novartis Investigative Site

Basel, CH, Switzerland

Site Status

Novartis Investigative Site

Westbruy on Trym, Bristol, United Kingdom

Site Status

Novartis Investigative Site

Exeter, Devon, United Kingdom

Site Status

Novartis Investigative Site

Plymouth, Devon, United Kingdom

Site Status

Novartis Investigative Site

Guildford, Surrey, United Kingdom

Site Status

Novartis Investigative Site

Avon, , United Kingdom

Site Status

Novartis Investigative Site

Birmingham, , United Kingdom

Site Status

Novartis Investigative Site

Dundee, , United Kingdom

Site Status

Novartis Investigative Site

Glasgow, , United Kingdom

Site Status

Novartis Investigative Site

Glasgow, , United Kingdom

Site Status

Novartis Investigative Site

London, , United Kingdom

Site Status

Novartis Investigative Site

London, , United Kingdom

Site Status

Novartis Investigative Site

London, , United Kingdom

Site Status

Novartis Investigative Site

London, , United Kingdom

Site Status

Novartis Investigative Site

London, , United Kingdom

Site Status

Novartis Investigative Site

Manchester, , United Kingdom

Site Status

Countries

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United States Australia Belgium Canada Finland Germany Netherlands Spain Switzerland United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2015-002715-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1UF1AG046150-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CAPI015A2201J

Identifier Type: -

Identifier Source: org_study_id

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