Alzheimer's Disease Neuroimaging Initiative 4
NCT05617014 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 1500
Last updated 2026-05-13
Summary
The Alzheimer's Disease Neuroimaging Initiative 4 (ADNI4) is a non-randomized, longitudinal, natural history study designed to validate biomarkers, improve clinical trial design, and advance understanding of Alzheimer's disease across the full disease spectrum. Building on the success of ADNI1, ADNI-GO, ADNI2, and ADNI3, ADNI4 integrates clinical, cognitive, imaging, genetic, and fluid biomarker data to characterize disease progression and predict cognitive decline.
ADNI4 includes both in-clinic and remote cohorts and a small complementary sub-cohort, Together Exploring Aging Minds (TEAM-ADNI), which evaluates community-based recruitment and longitudinal data collection approaches.
Conditions
Interventions
- RADIATION
-
Neuraceq
Amyloid PET imaging with Florbetaben (Neuraceq) injection
- RADIATION
-
Amyvid
Amyloid PET imaging with Amyvid (Florbetapir) injection
- RADIATION
-
Tauvid
Tau PET imaging with Tauvid (Flortaucipir) injection
- RADIATION
-
MK-6240
Tau PET imaging with MK-6240 injection
- RADIATION
-
NAV4694
Amyloid PET imaging with NAV4694 injection
- RADIATION
-
PI-2620
Tau PET imaging with PI-2620 injection
Sponsors & Collaborators
-
Northern California Institute of Research and Education
collaborator OTHER -
National Institute on Aging (NIA)
collaborator NIH -
Alzheimer's Therapeutic Research Institute
collaborator OTHER -
University of Southern California
lead OTHER
Principal Investigators
-
Michael Weiner, MD · University of California, San Francisco
-
Paul Aisen, MD · USC Alzheimer's Therapeutic Research Institute (ATRI)
-
Ronald Petersen, MD, PHD · Mayo Clinic
Eligibility
- Min Age
- 55 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-06-09
- Primary Completion
- 2027-07-31
- Completion
- 2027-07-31
Countries
- United States
- Canada
Study Locations
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