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Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD)
Sponsor: NYU Langone Health
Summary
This multi-site study will be the first to evaluate the dose-dependent effects of t-PBM in amnestic Mild Cognitive Impairment (aMCI) and early Alzheimer's Disease (AD) (CDR of 0.5-1, FAST 1-4; age 65-85) in a randomized clinical trial of 8 weeks of t-PBM vs. sham. At baseline, all subjects will complete initial neuropsychological testing. To elucidate mechanisms of action of t-PBM, prior to treatment, subjects will undergo neuroimaging related to critical features of AD: tau 18F MK-6240 load (PET), measures of brain bioenergetics (31P-MRS), and functional connectivity (rs-fMRI). After undergoing target engagement testing (t-PBM session performed during fMRI to detect BOLD changes with active t-PBM), subjects will then be randomized to t-PBM/sham and complete 24 t-PBM/sham treatments, \~11 min per day, 3 days per week, for 8 weeks. t-PBM will be administered via continuous, 808 nm wavelength laser delivery to the forehead bilaterally (at standard EEG electrode positions F4, F3).
Key Details
Gender
All
Age Range
65 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
196
Start Date
2021-04-27
Completion Date
2026-01-31
Last Updated
2025-12-09
Healthy Volunteers
No
Interventions
Active tPBM-2.0
The NIR continuous wave (average irradiance = 300 mW/cm2) will be used. The duration or irradiation will be for \~11 minutes (666 seconds).
Sham tPBM-2.0
The sham mode (0 mW/cm2) will be used. The duration or sham "irradiation" will be for \~11 minutes (666 seconds).
18F-MK-6240
PET tracer to be injected prior to PET imaging session, which will occur during baseline assessments
Locations (3)
Massachusetts General Hospital
Boston, Massachusetts, United States
NYU Langone Health
New York, New York, United States
Nathan Kline Institute
Orangeburg, New York, United States