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ACTIVE NOT RECRUITING
NCT04784416
PHASE2

Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD)

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

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

DEVICE

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).

DEVICE

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).

DRUG

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