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.
Study Type
OBSERVATIONAL
Enrollment
3,000
Amyloid PET imaging with NAV4694 injection
University of Alabama, Birmingham
Birmingham, Alabama, United States
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
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.
Time frame: 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
Time frame: Baseline, Month 12, Month 24, Month 36, Month 48, Month 60, and Month 72
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.
Time frame: 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.
Time frame: Baseline, Month 12, Month 24, Month 36, Month 48, Month 60, and Month 72
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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
...and 46 more locations