NYU Langone Health
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).
Mild Cognitive Impairment
Alzheimer Disease
Active tPBM-2.0
Sham tPBM-2.0
18F-MK-6240
PHASE2
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 125 participants |
Masking : | TRIPLE |
Primary Purpose : | TREATMENT |
Official Title : | Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD) |
Actual Study Start Date : | 2021-04-27 |
Estimated Primary Completion Date : | 2025-10-30 |
Estimated Study Completion Date : | 2026-01-31 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 65 Years to 85 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
RECRUITING
NYU Langone Health
New York, New York, United States, 10016
RECRUITING
Nathan Kline Institute
Orangeburg, New York, United States, 10962