NCT05617014

Alzheimer's Disease Neuroimaging Initiative 4

Alzheimer's Disease Neuroimaging Initiative 4 (ADNI4)

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Accepted

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.

Detailed description

Since its launch in 2004, the Alzheimer's Disease Neuroimaging Initiative (ADNI) has been a landmark public-private partnership focused on developing and validating biomarkers for Alzheimer's disease (AD) and improving clinical trial design. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3 studies and integrates clinical, cognitive, imaging, genetic, and biochemical biomarker data to characterize the full spectrum of Alzheimer's disease, from normal cognition through dementia. The ADNI4 study is a multi-center, non-randomized, longitudinal, natural history, non-treatment study. Approximately 1,500 participants will be enrolled across three cohorts: cognitively normal (CN), mild cognitive impairment (MCI), and dementia (DEM). Participants between the ages of 55 and 90 years will be enrolled at sites across the United States and Canada. Approximately 750 participants will be newly enrolled into ADNI4, and approximately 750 participants will be rollover participants continuing from prior ADNI studies. Clinical, cognitive, imaging, biomarker, and genetic characteristics will be assessed longitudinally across the three cohorts. Participants enrolled in ADNI4 will undergo longitudinal clinical and cognitive assessments, computerized cognitive batteries, biomarker and genetic testing, positron emission tomography (PET) imaging for amyloid and tau, magnetic resonance imaging (MRI), and collection of cerebrospinal fluid (CSF) for up to five years. ADNI4 incorporates both in-clinic and remote approaches, including web-based cognitive assessments and blood-based biomarkers, to support scalable identification and longitudinal monitoring of individuals across the disease continuum and to inform future clinical trial design. ADNI4 also includes the Together Exploring Aging Minds (TEAM-ADNI) cohort, a small complementary sub-cohort that evaluates community-based recruitment and flexible approaches to participant identification, enrollment, and longitudinal data collection. Across cohorts, ADNI4 aims to validate imaging and fluid biomarkers, improve clinical trial design, characterize longitudinal cognitive and biomarker changes, and identify predictors of disease progression. For more information, please visit the ADNI4 Study website: https://www.adni4.org/

Conditions

• Mild Cognitive Impairment
• Alzheimer Disease
• Dementia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-06-09
• Primary completion: 2027-07-31
• Completion: 2027-07-31
• First posted: 2022-11-15
• Last updated: 2026-03-25

Locations

62 sites across 2 countries: United States, Canada