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Initiate at least one clinical trial for primary prevention of AD and AD-related dementias among high risk individuals in midlife including a non-pharmacological treatment arm.
2030 RFA-AG-23-034 Mechanism-Focused Research to Promote Adherence to Healthful Behaviors to Prevent Mild Cognitive Impairment (MCI) and Alzheimer’s Disease (AD) and AD-Related Dementias (ADRD) (R61/R33 Clinical Trial Required) (Reissue of RFA-AG-22-016) RFA-AG-24-007: Roybal Centers for Translational Behavioral Research on Dementia Care, Caregiver Support, and Prevention of Alzheimer’s Disease and Related Dementias (AD/ADRD) (P30 Clinical Trial Required) (Reissue of RFA-AG-19-007) RFA-AG-25-005 Open Measurement Coordinating Network for Non-Pharmacological Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) Primary Prevention Trials (U24 Clinical Trail Not Allowed) RFA-AG-25-005: Open Measurement Coordinating Network for Non-Pharmacological Alzheimer's Disease (AD) and AD-Related Dementias (ADRD)Primary Prevention Trials (U24 Clinical Trial Optional) 8.D In Progress Initiate at least one clinical trial for primary prevention of AD and AD-related dementias among high risk individuals... DN 2012 AD Summit: 5E 2015 AD Summit: 3B, and 3D Workshop: NASEM Expert Meeting—Incorporating the Experimental Medicine Approach in the Development of Primary Prevention Trials for Alzheimer’s disease Workshop: The Landscape of Early (Neuro)Psychological Changes in AD/ADRD Project Workshop: Leveraging Technology-based Adaptive Interventions for AD-ADRD Non-Pharmacological Interventions Long-term Impact of Random Assignment to Intensive Lifestyle Intervention on Alzheimer’s Disease and Related Dementias: The Action for Health in Diabetes ADRD Study (Look AHEAD-MIND) Projects funded under RFA-AG-22-016 2021
Completion of at least one Phase II primary prevention trial for non-pharmacological interventions in midlife. Successful trials will provide evidence for potential therapeutic mechanisms and include the collection of biomarker data for future validation and longitudinal follow-up within the trial cohort.
Summary of Key Accomplishments
Establishment of effective primary prevention trials of non-pharmacological interventions for AD/ADRD has been complicated by a dearth of evidence that would inform the design of such trials. In 2024, NIA announced a funding initiative aimed at launching a national Open Measurement Coordinating Network for Non-Pharmacological AD/ADRD Primary Prevention Trials. NIA awarded the Open Measurement Network Initiative (OMNI AD/ADRD; U24AG092760-01) to (1) build an inventory of cognitive and functional measures and evaluate them against tiered criteria; (2) develop, adapt, and validate measures to fill critical gaps; (3) create an open multi-provider measurement infrastructure deployable across platforms; and (4) partner with stakeholders to ensure measures are widely adopted and used in AD/ADRD primary prevention trials that incorporate new targets for intervention.
The key accomplishments summary is current as of September 2025.