This is an observational study that requires participants to undergo a variety of exams (such as cognitive assessments, MRIs, PET scans, and optional lumbar punctures) over the course of five years. Some procedures will be in person and others may be remotely. Approximately 1,500 participants and their study partners will be enrolled at 65 sites throughout the United States and Canada, including participants who may have previously been enrolled in ADNI-3. Participants will represent three cohorts: individuals who are cognitively normal, those with mild cognitive impairment, and those who have mild Alzheimer’s disease.
What is the purpose of the ADNI-4 Study?
ADNI-4 continues the previous ADNI-1, ADNI-GO, ADNI-2 and ADNI-3 collaborative efforts to determine the relationships between clinical, cognitive, imaging, genetic and biomarker characteristics of the entire spectrum of Alzheimer’s disease. ADNI-4 will continue to discover, optimize, standardize and validate clinical trial measures and biomarkers used in Alzheimer’s research. The data collected in this trial, along with previous ADNI studies, play a central role in improving the design of current and future Alzheimer’s disease treatment trials. Participants will be able to learn the results of their amyloid PET scan if they wish.
Men and women ages 55 to 90 years old with no memory impairment, a diagnosis of mild cognitive impairment, or a diagnosis of mild Alzheimer’s disease may be eligible. A study partner is also required.
All participants meeting the inclusion and exclusion criteria standards will be enrolled, regardless of gender or race, but every effort will be made to actively recruit women and persons from Underrepresented Populations (URPs) who have been historically under-included in research, including Black or African American, Latino/a/x, Asian, Native Hawaiian/Other Pacific Islander, American Indian/Alaska Native adults, persons with less than 12 years of education, and people who live in rural areas. The study is working to include at least 50-60% (e.g., Black, Latinx, persons with less than 12 years of education) of newly enrolled participants from URPs.
If you are interested in learning more about the ADNI-4 study, please call (401) 455-6402 or send an e-mail to firstname.lastname@example.org. Ask about the “ADNI-4 Trial.”
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