Summary

Eligibility
for people ages 55-80 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California and other locations
Dates
study started
study ends around

Description

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 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:

  • 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.

Keywords

Preclinical Alzheimer's Disease, Alzheimer's Disease (AD), Preclinical Alzheimer Disease, Alzheimer Disease Biomarkers, Amyloid Beta, Blood-Based Biomarkers, Cognitive Decline, Alzheimer Disease Prevention, Alzheimer Disease, Amyloid Plaque, Cognitive Dysfunction, NAV4694

Eligibility

You can join if…

Open to people ages 55-80

  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.

You CAN'T join if...

  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.

Locations

  • UCSF
    San Francisco California 94158 United States
  • University of California, Davis
    Walnut Creek California 94598 United States
  • Stanford University
    Palo Alto California 94304 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
University of Southern California
Links
Alzheimer's Clinical Trials Consortium Alzheimer's Therapeutic Research Institute APEX Study Home Page
ID
NCT06416072
Study Type
Observational
Participants
Expecting 3000 study participants
Last Updated