Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD)
Status:
Recruiting
Trial end date:
2025-11-30
Target enrollment:
Participant gender:
Summary
This study will be the first to evaluate the dose-dependent effects of t-PBM in amnestic Mild
Cognitive Impairment (aMCI) (CDR of 0.5-1, FAST 1-3; age 65-85) in a randomized clinical
trial of 8 weeks of t-PBM vs. sham. At screening, 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).
Subjects will also undergo an open label t-PBM session performed during fMRI to detect BOLD
changes with t-PBM. Subjects will then be randomized to t-PBM/sham and complete treatments in
two participating centers (NYU/NKI acting as a single center, and MGH), ~10 min per day, 3
days per week, for 8 weeks. t-PBM will be administered via pulsed, 808nm wavelength laser
delivery to the forehead bilaterally (at standard EEG electrode positions F4, F3).
Phase:
Phase 2
Details
Lead Sponsor:
NYU Langone Health
Collaborators:
Alzheimer's Association LiteCure LLC National Institutes of Health (NIH)