Alzheimer's Plasma Extension

Running, not enrolling

Conditions studied: Preclinical Alzheimer's Disease, Early Preclinical Alzheimer's Disease

In brief

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 facts

Study ID

NCT06416072

Run by

University of Southern California

People needed

1000

Starts

2023-09-21

Expected to finish

2028-06-01

Last updated by the study team

2025-06-10

Who can join

Age: 55 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Documentation of the participant's informed consent to study procedures and for the use of protected health information (HIPAA Authorization, if applicable). 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 A3-45 screening.
• Has A3-45 screening plasma biomarker results required for determining eligibility to participate in the A3-45 trial.
• If an amyloid PET scan was conducted in A3-45, the scan was determined to be below the 20 centiloid cutpoint required for eligibility into the treatment arms of the A3 or A45 trial.
• 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.

You may not qualify if…

• 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.
• Participants enrolled in other observational studies may be permitted with Medical Monitor review and approval.
• Screen failed from A3-45 due to not meeting basic inclusion criterion (i.e., age requirement; current diagnosis of AD dementia).

Where it is running

• 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 Alabama, Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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