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.
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
- Conditions the study is for
- Preclinical Alzheimer's Disease, Alzheimer's Disease (AD)
- What is being tested?
- NAV4694
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 3,000 participants
- Where
- 56 sitesUnited States
- Study dates
- 21 Sep 2023to Jun 2028
- Phase
- Observational
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
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 group | Role | What they receive |
|---|---|---|
| Cohort 1: AHEAD 3-45 Participants | Approximately 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 Participants | Approximately 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.
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
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)
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
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.
- First posted16 May 2024
- Study start21 Sep 2023
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preclinical Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Clinical Trials Consortium, Alzheimer's Therapeutic Research Institute, Alzheimer's Association, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Paul S. Aisen, University of Southern California
- Investigators
- Paul Aisen, MD, Study director, University of Southern California (USC) Alzheimer's Therapeutic Research Institute (ATRI)Reisa Sperling, MD, Study director, Brigham and Women's Hospital and Massachusetts General Hospital
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