Alzheimer’s Disease Neuroimaging Initiative 4 (ADNI 4)

At present, the development of drugs for patients with Alzheimer’s disease is costly and time consuming. The validation of suitable biomarkers that track the progression of the disease and reflect underlying pathology is critical to streamlining this process. This is a multi-center observational research study designed to look at the relationships between clinical, cognitive, imaging, genetic, and biomarker tests in order to understand the full spectrum of Alzheimer’s disease (AD) from its earliest stage.

It will enroll about 1500 participants ages 55 – 90 (inclusive) across three cohorts: cognitively normal, mild cognitive impairment, and mild AD dementia. Approximately 750 of those participants will have also been in the ADNI-3 study. At least 50-60% of newly enrolled participants will come from populations that have been underrepresented in earlier iterations of ADNI (e.g., Black, Latinx, and persons with less than 12 years of education) to enhance the generalizability of results.

Study participation will last for about 4-5 years based on cohort (up to 6 visits total). All subjects will undergo MRI scans and up to 8 PET scans and can participate in optional lumbar puncture procedures (up to 3 lumbar punctures). They will also have the option to participate in a brain donation program.

The study will enroll men and women aged 55-90 years across CN, MCI, and Dementia (DEM) participant groups, as specified in the entry criteria. Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the project director and ADNI coordinating center.