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Sponsor: University of Southern California
Conditions: Preclinical Alzheimer's Disease, Alzheimer's Disease (AD)
Interventions: NAV4694
Countries: United States
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.
Sex: ALL
Age: 55 Years to 80 Years
Healthy volunteers: Yes
Study type: OBSERVATIONAL
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.
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Sun City, Arizona, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Walnut Creek, California, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Washington D.C., District of Columbia, United States
- Delray Beach, Florida, United States
- Jacksonville, Florida, United States
- Lady Lake, Florida, United States
- Maitland, Florida, United States
- Miami, Florida, United States
- Miami Beach, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Fairway, Kansas, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Boston, Massachusetts, United States
- Plymouth, Massachusetts, United States
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