NCT04784416

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Mild Cognitive Impairment
• Alzheimer Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-04-27
• Primary completion: 2025-10-30
• Completion: 2026-01-31
• First posted: 2021-03-05
• Last updated: 2025-12-09

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study