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NCT04784416 · ClinicalTrials.gov registry record · Phase 2
Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD)
A Phase 2 study of Alzheimer Disease and Mild Cognitive Impairment, sponsored by NYU Langone Health.
- Active
- Registry status
- Phase 2
- Development phase
- 196
- Enrollment target
- 3
- Study locations
NCT04784416 is a Phase 2 study of Alzheimer Disease and Mild Cognitive Impairment that is active but no longer recruiting, run by NYU Langone Health. The registered enrollment target is 196 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (93% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT04784416, a Phase 2 study of Alzheimer Disease and Mild Cognitive Impairment, is active but no longer recruiting, sponsored by NYU Langone Health.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 196 participants
- Enrollment target
- 3
- Study locations
Study 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 Studied
Interventions
- DRUG 18F-MK-6240
- DEVICE Active tPBM-2.0
- DEVICE Sham tPBM-2.0
Study Locations (3)
New York
- NYU Langone Health - New York
- Nathan Kline Institute - Orangeburg
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2021-04-27 |
| Est. Completion | 2026-01-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04784416
The ClinicalTrials.gov registry entry for NCT04784416 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 196 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (93% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 3 interventions - of which 18F-MK-6240 is the first listed.
NCT04784416 reports 3 study locations spanning 2 distinct geographic areas - top geographies include New York, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04784416 about?
NCT04784416 is a clinical study titled "Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD)". 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 comp...
What is the current status of trial NCT04784416?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 196 participants. The study started on 2021-04-27. Estimated completion is 2026-01-31.
What conditions does trial NCT04784416 study?
This clinical trial studies the following conditions: Alzheimer Disease, Mild Cognitive Impairment.
What interventions are being tested in trial NCT04784416?
The interventions under investigation include: 18F-MK-6240 (DRUG), Active tPBM-2.0 (DEVICE), Sham tPBM-2.0 (DEVICE).
Who is sponsoring clinical trial NCT04784416?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04784416 being conducted?
This trial has 3 study locations across Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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