The ADNI4 is multi-center, a non-randomized, natural history, non-treatment study. 1,150 participants will be enrolled across three cohorts: cognitively normal (CN), mild cognitive impairment (MCI) and dementia (DEM). Participants between the ages of 55-90 (inclusive) will be enrolled at 59 sites in the United States and Canada. Approximately, 750 participants will be newly enrolled into the ADNI4 study, while 750 participants will be rollover participants, continuing their participation from previous ADNI studies. Clinical/cognitive, imaging, biomarker, and genetic characteristics will be assessed across the three cohorts.~Participants enrolled in the ADNI4 study will undergo longitudinal clinical and cognitive assessments, computerized cognitive batteries, biomarker and genetic tests, PET (amyloid and tau) and MRI scans and cerebral spinal fluid (CSF) collection for up to 5 years.
Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) study has been to validate biomarkers for Alzheimer's disease (AD) clinical trials. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3 studies that have combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of AD.