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ENROLLING BY INVITATION

NCT06416072

Alzheimer's Plasma Extension

Sponsor: University of Southern California

View on ClinicalTrials.gov

Summary

The goal of this observational study is to learn how Alzheimer's disease-related blood biomarkers, brain amyloid, and memory and thinking abilities change over time. The study will include up to 3,000 people who previously did not qualify for an anti-amyloid Alzheimer's disease prevention trial based on their amyloid eligibility. Participants may have previously screened for the AHEAD 3-45 Study, A4 Study, or another anti-amyloid Alzheimer's disease prevention trial. The main questions this study aims to answer are: * Can Alzheimer's disease-related blood tests help predict future buildup of amyloid in the brain? * How are changes in Alzheimer's disease-related blood biomarkers related to changes in brain amyloid, memory, thinking, and self-reported cognitive function? * Do these changes differ based on factors such as sex, APOE genetic status, race, ethnicity, socioeconomic status, or social factors? Participants will be followed for about 6 years. They will complete memory and thinking assessments and questionnaires and provide blood samples. Some participants may also be asked to take part in optional activities, including brain imaging with positron emission tomography (PET) or magnetic resonance imaging (MRI), digital cognitive assessments, and questionnaires about habits and social factors.

Key Details

Gender

All

Age Range

55 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

3000

Start Date

2023-09-21

Completion Date

2028-06

Last Updated

2026-08-18

Healthy Volunteers

Yes

Conditions

Preclinical Alzheimer's Disease Alzheimer's Disease (AD)

Interventions

RADIATION

NAV4694

Amyloid PET imaging with NAV4694 injection

Inclusion Criteria: 1. Documentation of the participant's informed consent to study procedures and for the use of protected health information (HIPAA Authorization, or local, regional or country-specific equivalent). Informed consent processes and documentation must adhere to state laws/local requirements, including consent provided by the participant's legally authorized representative (LAR), responsible next of kin, surrogate consent with assent, etc. 2. Previously consented to participate in an anti-amyloid preclinical AD study (e.g., AHEAD 3-45, A4 or other anti-amyloid preclinical AD study). 3. Has screening results that did not meet amyloid eligibility criteria for an anti-amyloid preclinical AD trial (e.g., AHEAD 3-45, A4, or other anti-amyloid preclinical AD study). 4. 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. For participants who screen failed from the AHEAD 3-45 Study: 5. Has AHEAD 3-45 screening plasma biomarker results required for determining eligibility to participate in the AHEAD 3-45 Study. Exclusion Criteria: 1. Current treatment with an FDA approved medication for Alzheimer's disease, including prior or current treatment with a prohibited medication. 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. 3. Screen failed from an anti-amyloid preclinical AD trial (e.g. AHEAD 3-45, A4 or other anti-amyloid preclinical AD trial) due to not meeting basic inclusion criteria (i.e., age requirement; current diagnosis of AD dementia). For participants participating in the optional amyloid PET imaging sub-study: 4. Is pregnant or breastfeeding.

Locations (56)

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