Assessing & Measuring Target Engagement: Mechanistic & Clinical Outcomes

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Assessing and Measuring Target Engagement: Mechanistic and Clinical Outcome Measures for Brain Disorders of Aging

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This is the second of three meetings that are part of Phase I of an NIH/Foundation for the National Institutes of Health (FNIH) project to develop evidence-based music therapies for brain disorders of aging.

This meeting will gather input from participants in the music therapy/music medicine, neuroscience, behavioral intervention development, clinical trial methodology, and patient advocacy/art organization communities. The NIH planning committee will assess, evaluate, and identify the most feasible and relevant functional outcome measures in domains relevant to brain disorders of aging: cognition, emotion, and motor and sensory functions. This core dataset of outcome measures will be used in future NIH-funded music-based intervention protocols.

Draft Agenda

1:00-1:10 p.m. | Welcome

  • Francis S. Collins, M.D., Ph.D., Director, National Institutes of Health (NIH)
  • Renée Fleming, Renowned Soprano, Arts and Health Advocate

1:10-1:15 p.m. | Setting the Stage: Music-Based Interventions (MBIs) for Brain Disorders of Aging

  • Coryse St. Hillaire-Clarke, Ph.D., Program Director, Sensory and Motor Disorders of Aging Program, Division of Neuroscience, National Institute on Aging

1:15-1:40 p.m. | Measurement Advances: Implications for the Sound Health Initiative

  • William T. Riley, Ph.D., Director, Office of Behavioral and Social Sciences Research

Presentation (20 minutes)

Question and Answer Session (5 minutes)

1:40-1:50 p.m. | Charge to Panelists and Thematic Group Discussion Setup

  • Emmeline Edwards, Ph.D., Director, Division of Extramural Research, National Center for Complementary and Integrative Health
  • Alan Weil, J.D., M.P.P., Editor-in-Chief, Health Affairs

1:50-2:10 p.m. | Question 1: When designing MBIs for brain disorders of aging, what are the most important functional domains to be considered (e.g., emotion, cognition, motor, sensory, interoception)?

2:10-2:30 p.m. | Question 2: What are the most useful outcome measures (physiological, behavioral, etc.) for Alzheimer’s disease and Alzheimer’s disease related dementias (AD/ADRD), Parkinson’s disease (PD), and stroke that can be used to assess target engagement? What are the key characteristics of useful outcome measures?

  • Functional imaging and functional connectivity measures
  • Electrophysiological measures
  • Social and behavioral measures
  • Psychological and physiological measures
  • Linguistic measures
  • Music-centered measures

2:30-2:40 p.m. | Break

2:40-3:10 p.m. | Question 3: What are the advantages and disadvantages to be considered when prioritizing clinical outcome measures for AD/ADRD, PD, and stroke (e.g., objective, performance-based, patient-reported, functional)?

  • Prioritization based on the intervention
  • Proximal vs. distal (i.e., short- and long-term) outcome measures
  • Primary vs. secondary outcome measures
  • Engaging participants and caregivers
  • Remotely collected measures (i.e., ecological momentary assessment [EMA])

3:10-3:25 p.m. | Question 4: How useful are existing tools and resources (e.g., the Patient-Reported Outcomes Measurement Information System [PROMIS], the NIH Toolbox, Quality of Life in Neurological Disorders [Neuro-QoL], Science of Behavior Change [SOBC]) for studying MBIs for brain disorders of aging?

What new tools or resources are needed?

3:25-3:55 p.m. | Broad Question and Answer Session

Videocast audience and Zoom meeting participants

3:55-4:00 p.m. | Wrap-Up and Next Steps

  • Robert Finkelstein, Ph.D., Director, Division of Extramural Activities, National Institute of Neurological Disorders and Stroke

Individuals who need reasonable accommodation to participate should contact or the Federal Relay, 1-800-877-8339, by Friday, June 11.

OMB No.: 0925-0740

Expiration Date: 07/31/2022

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