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Can a simple blood test predict Alzheimer's years before symptoms?

NCT ID NCT06416072

Knowledge-focused Sponsor: University of Southern California Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This observational study follows up to 3,000 people who were previously screened for anti-amyloid Alzheimer's prevention trials but did not qualify based on amyloid levels. Over about 6 years, researchers will track changes in blood biomarkers, brain amyloid (via PET imaging), and memory and thinking abilities. The goal is to understand how these measures relate to each other and whether blood tests can predict future amyloid buildup in the brain.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Amyloid PET imaging with NAV4694 injection
What this could lead to
If successful, this study could improve early detection of Alzheimer's disease using simple blood tests, potentially enabling earlier intervention and better monitoring of disease progression.
What could go wrong
This is an observational study, so it cannot prove cause and effect. Results may take years to emerge, and findings might not apply to all populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 3,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study will enroll up to 3,000 participants who previously screen failed from an anti-amyloid preclinical Alzheimer's disease (AD) trial based on amyloid eligibility. Up to 1,500 participants will have previously consented to the AHEAD 3-45 Study and screen failed due to a negative amyloid PET scan or prior to PET imaging. Up to 1,500 participants will have previously screen failed from the A4 Study or another anti-amyloid preclinical AD trial based on amyloid eligibility.

Ages

55 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction Plaque, Amyloid

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer's disease(AD) Preclinical Alzheimer's disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    56 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006, United States

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Boston University

    Boston, Massachusetts, 02215, United States

  • Brain Matters Research

    Delray Beach, Florida, 33445, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 21155, United States

  • Butler Hospital Memory and Aging Program

    Providence, Rhode Island, 02906, United States

  • Case Western Reserve University

    Beachwood, Ohio, 44122, United States

  • Central States Research, LLC

    Tulsa, Oklahoma, 74136, United States

  • Charter Research

    Orlando, Florida, 32803, United States

  • Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas

    Las Vegas, Nevada, 89101, United States

  • Cleveland Clinic Lou Ruvo Center for Brain Health, Ohio

    Cleveland, Ohio, 44195, United States

  • Columbia University

    New York, New York, 10032, United States

  • Eastern Virginia Medical School at Old Dominion University

    Norfolk, Virginia, 23510, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Georgetown University

    Washington D.C., District of Columbia, 20007, United States

  • Gonzalez MD & Aswad MD Health Services

    Miami, Florida, 33135, United States

  • Headlands Eastern MA LLC

    Plymouth, Massachusetts, 02360, United States

  • Houston Methodist Neurological Institute

    Houston, Texas, 77030, United States

  • Howard University

    Washington D.C., District of Columbia, 20060, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21224, United States

  • K2 Medical Research - The Villages

    Lady Lake, Florida, 32159, United States

  • K2 Medical Research, LLC

    Maitland, Florida, 32751, United States

  • Mayo Clinic, Jacksonville

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic, Rochester

    Rochester, Minnesota, 55905, United States

  • Mount Sinai School of Medicine

    New York, New York, 10029, United States

  • National Clinical Research Inc.

    Richmond, Virginia, 23294, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Ralph H. Johnson VA Health Care System

    Charleston, South Carolina, 29401, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Sharp Neurocognitive Research Center

    San Diego, California, 92123, United States

  • Stanford University

    Palo Alto, California, 94304, United States

  • University of Alabama, Birmingham

    Birmingham, Alabama, 35233, United States

  • University of California, Davis

    Walnut Creek, California, 94598, United States

  • University of California, Irvine

    Irvine, California, 92697, United States

  • University of California, San Francisco

    San Francisco, California, 94158, United States

  • University of Kansas

    Fairway, Kansas, 66205, United States

  • University of Kentucky

    Lexington, Kentucky, 40504, United States

  • University of Michigan, Ann Arbor

    Ann Arbor, Michigan, 48105, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Rochester Medical Center

    Rochester, New York, 14620, United States

  • University of South Florida - Health Byrd Alzheimer Institute

    Tampa, Florida, 33613, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229, United States

  • University of Texas, Southwestern MC at Dallas

    Dallas, Texas, 75390, United States

  • University of Washington, Memory and Brain Wellness Center

    Seattle, Washington, 98195, United States

  • University of Wisconsin

    Madison, Wisconsin, 53792, United States

  • Vanderbilt University Medical Center Center for Cognitive Medicine

    Nashville, Tennessee, 37212, United States

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157, United States

  • Washington University, St. Louis

    St Louis, Missouri, 63108, United States

  • Wien Center for Clinical Research

    Miami Beach, Florida, 33140, United States

  • Yale University School of Medicine

    New Haven, Connecticut, 06510, United States

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