AzTrials
AzTrials

Preclinical Alzheimer's DiseaseAPEXNCT06416072

Alzheimer's Plasma Extension

An observational study of Preclinical Alzheimer's Disease and Alzheimer's Disease (AD), run by University of Southern California at 56 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 55 to 80 yearsHealthy volunteers can take part
What is being tested?
NAV4694
How many people
3,000 participants
Where
56 sitesUnited States
Study dates
21 Sep 2023to Jun 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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.
  • Previously consented to participate in an anti-amyloid preclinical AD study (e.g., AHEAD 3-45, A4 or other anti-amyloid preclinical AD study).
  • 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).
  • 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:
  • Has AHEAD 3-45 screening plasma biomarker results required for determining eligibility to participate in the AHEAD 3-45 Study.

Who cannot join

  • Current treatment with an FDA approved medication for Alzheimer's disease, including prior or current treatment with a prohibited medication.
  • 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.
  • 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:
  • Is pregnant or breastfeeding.

Trial locations and contacts

56 sites in 1 country. Contact the study team or a site near you to ask about taking part.

56 sites in 1 country

United States56 sites

  • University of Michigan, Ann Arbor

    Ann Arbor, Michigan, 48105

  • Emory University

    Atlanta, Georgia, 30322

  • Johns Hopkins University

    Baltimore, Maryland, 21224

  • Case Western Reserve University

    Beachwood, Ohio, 44122

  • University of Alabama, Birmingham

    Birmingham, Alabama, 35233

  • Boston University

    Boston, Massachusetts, 02215

  • Brigham and Women's Hospital

    Boston, Massachusetts, 21155

  • Ralph H. Johnson VA Health Care System

    Charleston, South Carolina, 29401

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Cleveland Clinic Lou Ruvo Center for Brain Health, Ohio

    Cleveland, Ohio, 44195

  • Ohio State University

    Columbus, Ohio, 43210

  • University of Texas, Southwestern MC at Dallas

    Dallas, Texas, 75390

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • University of Kansas

    Fairway, Kansas, 66205

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Houston Methodist Neurological Institute

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • University of California, Irvine

    Irvine, California, 92697

  • Mayo Clinic, Jacksonville

    Jacksonville, Florida, 32224

  • K2 Medical Research - The Villages

    Lady Lake, Florida, 32159

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

    Las Vegas, Nevada, 89101

  • University of Kentucky

    Lexington, Kentucky, 40504

  • University of Southern California

    Los Angeles, California, 90033

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • K2 Medical Research, LLC

    Maitland, Florida, 32751

  • Gonzalez MD & Aswad MD Health Services

    Miami, Florida, 33135

  • Wien Center for Clinical Research

    Miami Beach, Florida, 33140

  • Vanderbilt University Medical Center Center for Cognitive Medicine

    Nashville, Tennessee, 37212

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Columbia University

    New York, New York, 10032

  • Eastern Virginia Medical School at Old Dominion University

    Norfolk, Virginia, 23510

  • Charter Research

    Orlando, Florida, 32803

  • Stanford University

    Palo Alto, California, 94304

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Headlands Eastern MA LLC

    Plymouth, Massachusetts, 02360

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Butler Hospital Memory and Aging Program

    Providence, Rhode Island, 02906

  • National Clinical Research Inc.

    Richmond, Virginia, 23294

  • Mayo Clinic, Rochester

    Rochester, Minnesota, 55905

  • University of Rochester Medical Center

    Rochester, New York, 14620

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Sharp Neurocognitive Research Center

    San Diego, California, 92123

  • University of California, San Francisco

    San Francisco, California, 94158

  • University of Washington, Memory and Brain Wellness Center

    Seattle, Washington, 98195

  • Washington University, St. Louis

    St Louis, Missouri, 63108

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • University of South Florida - Health Byrd Alzheimer Institute

    Tampa, Florida, 33613

  • Central States Research, LLC

    Tulsa, Oklahoma, 74136

  • University of California, Davis

    Walnut Creek, California, 94598

  • Georgetown University

    Washington D.C., District of Columbia, 20007

  • Howard University

    Washington D.C., District of Columbia, 20060

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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:

Read more
  • 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.

Being tested
NAV4694
Keywords
Preclinical Alzheimer Disease, Alzheimer Disease Biomarkers, Amyloid Beta, Blood-Based Biomarkers, Cognitive Decline, Alzheimer Disease Prevention
Medical subject headings
Alzheimer Disease, Plaque, Amyloid, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NAV4694Radiation

    Also called [18F]NAV4694

    Amyloid PET imaging with NAV4694 injection

Study groups in NCT06416072
Study groupRoleWhat they receive
Cohort 1: AHEAD 3-45 ParticipantsApproximately 1,500 participants who consented to participate in the AHEAD 3-45 Study and screen failed due to a negative amyloid PET scan or screen failed prior to PET imaging
Receives: Radiation: NAV4694
Cohort 2: Other Anti-Amyloid Prevention Trial ParticipantsApproximately 1,500 participants who previously screen failed from the A4 Study or another anti-amyloid prevention trial on the basis of amyloid eligibility.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of change from Baseline through Month 72 in plasma beta-amyloid (Aβ) 40 or 42 ratio

    Change in plasma Aβ42/Aβ40 ratio over the longitudinal follow-up period will be assessed using repeated blood-based biomarker measurements.

    Measured: Baseline, Month 12, Month 24, Month 36, Month 48, Month 60, and Month 72

  2. Rate of change from Baseline through Month 72 in plasma phosphorylated tau (ptau) 217

    Assess longitudinal changes from initial visit in plasma phosphorylated tau (ptau) 217 ratio using a proteomics assay

    Measured: Baseline, Month 12, Month 24, Month 36, Month 48, Month 60, and Month 72

Secondary outcomes (2)

  1. Rate of Change from Baseline through Month 72 as measured by the Preclinical Alzheimer Cognitive Composite 5 (PACC5)

    The Preclinical Alzheimer Cognitive Composite 5 (PACC5) is a composite measure of episodic memory, timed executive function, semantic memory, and global cognition. It includes: Free and Cued Selective Reminding Test (FCSRT), using the Free + Total Free and Cued Recall score (0-96, higher scores indicate better performance); delayed Paragraph Recall (0-25, higher scores indicate better recall); Digit Symbol Substitution Test (DSST), number correctly completed in 90 seconds (0-91, higher scores indicate better performance); Mini-Mental State Examination (MMSE) (0-30, higher scores indicate better performance); and Category Fluency, number of appropriate words generated, with higher scores indicating better performance.

    Measured: Baseline, Month 12, Month 24, Month 36, Month 48, Month 60, and Month 72

  2. Rate of Change from Baseline through Month 72 as measured Cognitive Function Index (CFI)

    The participant-reported Cognitive Function Index (CFI) assesses the participant's perceived ability to perform high-level functional tasks in daily life and overall cognitive functional ability. Only the participant-CFI portion will be administered. Participants rate their own abilities using 18 questions. The total participant-CFI score ranges from 0 (minimum) to 18 (maximum), with higher scores indicating greater impairment. The CFI may be self-administered or completed as an interview conducted by clinical site personnel in person or, if necessary, over the phone.

    Measured: Baseline, Month 12, Month 24, Month 36, Month 48, Month 60, and Month 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2024
  2. Study start21 Sep 2023
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06416072
Sponsor's protocol ID
ATRI-013
Other IDs
5R01AG054029
Acronym
APEX
Status last verified
Aug 2026
First submitted
21 Feb 2023
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Preclinical Alzheimer's Disease and Alzheimer's Disease (AD), run by University of Southern California at 56 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of change from Baseline through Month 72 in plasma beta-amyloid (Aβ) 40 or 42 ratio (time frame: Baseline, Month 12, Month 24, Month 36, Month 48, Month 60, and Month 72). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06416072.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in