Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1000 participants
OBSERVATIONAL
2023-09-21
2028-06-30
Brief Summary
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Approximately 1000 participants will be enrolled across three groups:
* Group A: Approximately 500 participants who are discordant on screening (plasma positive / Positron Emission Tomography (PET) negative),
* Group B: Approximately 250 participants who are concordant on screening (plasma negative / PET negative), and
* Group C: Approximately 250 participants selected from the individuals who previously screen failed prior to PET for the AHEAD study with oversampling of racial and ethnic populations underrepresented in Alzheimer's disease (AD) clinical trials.
Primary Objectives:
* Collect longitudinal cognitive and functional assessments and blood-based biomarker data
* Evaluate, characterize, and compare the longitudinal cognitive and functional data between the three groups of participants
* Compare longitudinal change across race and ethnicity, sex, and Apolipoprotein E (ApoE) status
Exploratory Objectives:
• Collect baseline amyloid PET on participants without prior amyloid PET data (Group C)
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group A
Approximately 500 participants who screen failed from the AHEAD study that were plasma positive / PET negative
No interventions assigned to this group
Group B
Approximately 250 participants who screen failed from the AHEAD study that were plasma negative / PET negative
No interventions assigned to this group
Group C
Approximately 250 participants who screen failed prior to PET imaging will undergo amyloid PET imaging with NAV4694 injection.
NAV4694
Amyloid PET imaging with NAV4694 injection
Interventions
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NAV4694
Amyloid PET imaging with NAV4694 injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Previously consented to participate in A3-45 screening.
3. Has A3-45 screening plasma biomarker results required for determining eligibility to participate in the A3-45 trial.
4. If an amyloid PET scan was conducted in A3-45, the scan was determined to be below the 20 centiloid cutpoint required for eligibility into the treatment arms of the A3 or A45 trial.
5. As assessed by the site PI, participant is likely to be able to comply with the protocol, including completion of all required procedures for the duration of the study, and has adequate vision, hearing (hearing aid permitted), and literacy in English or Spanish sufficient for compliance with required testing procedures.
Exclusion Criteria
2. Enrollment in another investigational study, or intake of investigational drug, within 30 days prior to screening, or five half-lives of the investigational drug, whichever is longer, unless it can be documented that the participant was in the placebo treatment arm.
Participants enrolled in other observational studies may be permitted with Medical Monitor review and approval.
3. Screen failed from A3-45 due to not meeting basic inclusion criterion (i.e., age requirement; current diagnosis of AD dementia).
55 Years
80 Years
ALL
Yes
Sponsors
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Alzheimer's Clinical Trials Consortium (ACTC)
UNKNOWN
Alzheimer's Therapeutic Research Institute
OTHER
Alzheimer's Association
OTHER
University of Southern California
OTHER
Responsible Party
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Paul S. Aisen
Professor
Principal Investigators
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Paul Aisen, MD
Role: STUDY_DIRECTOR
University of Southern California (USC) Alzheimer's Therapeutic Research Institute (ATRI)
Reisa Sperling, MD
Role: STUDY_DIRECTOR
Brigham and Women's Hospital and Massachusetts General Hospital
Locations
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University of Alabama, Birmingham
Birmingham, Alabama, United States
Banner Alzheimer's Institute
Phoenix, Arizona, United States
Banner Sun Health Research Institute
Sun City, Arizona, United States
University of California, Irvine
Irvine, California, United States
University of Southern California
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
Sharp Neurocognitive Research Center
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
University of California, Davis
Walnut Creek, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Georgetown University
Washington D.C., District of Columbia, United States
Howard University
Washington D.C., District of Columbia, United States
Brain Matters Research
Delray Beach, Florida, United States
Mayo Clinic, Jacksonville
Jacksonville, Florida, United States
K2 Medical Research - The Villages
Lady Lake, Florida, United States
K2 Medical Research, LLC
Maitland, Florida, United States
Gonzalez MD & Aswad MD Health Services
Miami, Florida, United States
Wien Center for Clinical Research
Miami Beach, Florida, United States
Charter Research
Orlando, Florida, United States
University of South Florida - Health Byrd Alzheimer Institute
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Kansas
Fairway, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Johns Hopkins University
Baltimore, Maryland, United States
Boston University
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Headlands Eastern MA LLC
Plymouth, Massachusetts, United States
University of Michigan, Ann Arbor
Ann Arbor, Michigan, United States
Mayo Clinic, Rochester
Rochester, Minnesota, United States
Washington University, St. Louis
St Louis, Missouri, United States
Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas
Las Vegas, Nevada, United States
Mount Sinai School of Medicine
New York, New York, United States
Columbia University
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Case Western Reserve University
Beachwood, Ohio, United States
Cleveland Clinic Lou Ruvo Center for Brain Health, Ohio
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Central States Research, LLC
Tulsa, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Butler Hospital Memory and Aging Program
Providence, Rhode Island, United States
Ralph H. Johnson VA Health Care System
Charleston, South Carolina, United States
Vanderbilt University Medical Center Center for Cognitive Medicine
Nashville, Tennessee, United States
University of Texas, Southwestern MC at Dallas
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Methodist Neurological Institute
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Eastern Virginia Medical School at Old Dominion University
Norfolk, Virginia, United States
National Clinical Research Inc.
Richmond, Virginia, United States
University of Washington, Memory and Brain Wellness Center
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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Related Links
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Alzheimer's Clinical Trials Consortium
Alzheimer's Therapeutic Research Institute
APEX Study Home Page
Other Identifiers
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ATRI-013
Identifier Type: -
Identifier Source: org_study_id
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