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

> **NIH NIH R01** · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · 2020 · $873,715

## Abstract

PROJECT SUMMARY
 The prevalence of Alzheimer disease (AD) is projected to increase as the population ages, and current
treatments are only minimally effective. Recently, emphasis has been placed on understanding and treating
the factors that influence early brain pathology in order to slow the ultimate clinical expression of AD.
Transcranial photobiomodulation (t-PBM) with near-infrared (NIR) light penetrates robustly into the cerebral
cortex, stimulating the mitochondrial respiratory chain, and also significantly increases cerebral blood flow
(CBF). Early data suggests t-PBM may be efficacious in improving cognitive deficits in early AD and in
amnestic mild cognitive impairment (aMCI). This project aims to test, in a randomized controlled trial, the
efficacy and safety of 24 sessions of t-PBM, delivered over 8 weeks and compared to sham, in improving
clinical symptoms of aMCI. Additionally, we will explore the brain mechanisms of t-PBM in aMCI, by testing
whether baseline tau burden (measured with 18F-MK6240), or changes in mitochondrial function measures
over 8 weeks (measured by 31P-MRSI) moderate the changes observed in cognitive functions after t-PBM
therapy. We will also use changes in fMRI blood-oxygenation-level dependent (BOLD) after a single treatment,
to demonstrate t-PBM-dependent increases in prefrontal cortex (PFC) cortical blood flow (CBF). The study will
be done in parallel at New York University, Nathan Kline Institute and at Massachusetts General Hospital. The
importance of this study is threefold: (1) it targets aMCI, an important prodromal stage of AD, which lacks
adequate approved treatments, (2) it evaluates the efficacy and safety of t-PBM, an innovative, non-invasive
technology which has a well-established safety profile, for improving brain function and cognition at the
prodromal AD stages, and, (3) explores the association of t-PBM treatment effects with important biomarkers
relevant for AD illness progression. If effects are confirmed, the present study will both support short-term
clinical development of an easy to scale device for the treatment of aMCI and AD, while also validating
biomarkers for the development of future, novel modulation strategies.

## Key facts

- **NIH application ID:** 10034447
- **Project number:** 1R01AG068248-01
- **Recipient organization:** NEW YORK UNIVERSITY SCHOOL OF MEDICINE
- **Principal Investigator:** PAOLO CASSANO
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $873,715
- **Award type:** 1
- **Project period:** 2020-09-15 → 2025-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10034447

## Citation

> US National Institutes of Health, RePORTER application 10034447, Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD) (1R01AG068248-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10034447. Licensed CC0.

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