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ACTIVE NOT RECRUITING
NCT06416072

Alzheimer's Plasma Extension

Sponsor: University of Southern California

View on ClinicalTrials.gov

Summary

The APEX study is a multicenter, observational study designed to capture longitudinal follow-up of plasma biomarkers and cognitive and functional assessments on individuals who screen failed in the AHEAD study over approximately 4 years. 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)

Key Details

Gender

All

Age Range

55 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2023-09-21

Completion Date

2028-06

Last Updated

2025-06-10

Healthy Volunteers

Yes

Interventions

RADIATION

NAV4694

Amyloid PET imaging with NAV4694 injection

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