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Milestone 8.B

Increase investment in clinical trials that robustly test a variety of lifestyle and other non-pharmacological interventions. Employ precision medicine research principles in non-pharmacologic intervention studies by incorporating deep molecular profiling and digital/wearable technologies for tracking responsiveness to the intervention.


Success Criteria

  • Initiate clinical trials for at least 3 non- pharmacological interventions aimed at AD and ADRD treatment and/or prevention. Ensure that the trials are designed to robustly test the therapeutic mechanism and to enable comprehensive success/failure analysis upon the trial completion.
  • Incorporate digital health devices and/or deep multi-omic profiling in at least six (6) non-pharmacologic intervention studies to:
    • Track adherence to treatment and treatment response; 
    • Understand mechanisms of action and person-specific trajectories of response; 
    • Identify optimal ways to integrate digital technologies and optimize the analysis and interpretation of the collected data. 
  • Support a systematic effort to provide evidence-based guidelines for the development of protocols for the design and delivery of non-pharmacologic interventions.
  • Support research focused on identifying effective strategies to modify behavior to increase adherence and compliance in trials and best ways to support and maintain behavior modification and participant engagement across diverse populations, after the trial is complete.
  • Employ engaged research models for stakeholder involvement as research partners, including centers and other research networks.

Summary of Key Accomplishments

NIA has funded more than 20 early- and late-stage clinical trials focused on lifestyle, cognitive training, or brain stimulation interventions. One example is a trial examining whether a simple sleep intervention improves cognitive performance and reduces abnormal brain activity due to AD. Another promising example is a trial studying whether a specific cognitive training exercise reduces dementia risk. Four trials testing various lifestyle interventions (individually or in combination) for AD treatment and prevention have been enhanced with biomarker data to assess responsiveness to treatment and inform the design of individualized interventions.

This information is current as of July 2022.


Research Implementation Area
Non-Pharmacological Interventions
Timeline
2017–2024
Status
In Progress

Accomplishments/Implementation Activities

Funding Initiatives

Research Programs and Resources

Research Highlights

Relevant Recommendations

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An official website of the National Institutes of Health