RecruitingNot ApplicableNCT07224607

Transcranial Photobiomodulation (tPBM) in Alzheimer's Disease Study

A Longitudinal Study Investigating the Effects of Photobiomodulation (PBM) on Cognitive Function and Alzheimer's Disease (AD)-Related Biomarkers in Individuals With Mild Cognitive Impairment (MCI) or Dementia Due to AD


Sponsor

Cedars-Sinai Medical Center

Enrollment

45 participants

Start Date

Dec 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to see if a special light treatment, called photobiomodulation, can help people with memory problems such as Mild Cognitive Impairment or Mild Dementia due to Alzheimer's disease. The light is given to the forehead using an FDA-cleared medical device. This device is cleared to provide topical heating to elevate tissue temperature for temporary relief of muscle and joint pain, muscle spasm and stiffness associated with arthritis. It also increases blood circulation and relaxes muscle tissue. This device is being used "off-label," meaning it will be used in a way that is different than its cleared use. We want to learn whether this light treatment can improve executive function, and whether it changes certain inflammatory and neurodegeneration related signals in the blood. To do this, we will apply the photobiomodulation device to your forehead. We will also ask you questions and give you cognitive tests before and after light treatment. We will also collect blood samples before and after treatment.


Eligibility

Min Age: 55 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a device that delivers gentle light energy to the brain (transcranial photobiomodulation, or tPBM) to see whether it can improve memory and thinking in people with mild cognitive impairment or early Alzheimer's disease. Participants attend weekly in-person treatment sessions at Cedars-Sinai Medical Center. **You may be eligible if...** - You are between 55 and 89 years old - You have been diagnosed with mild cognitive impairment or mild dementia likely due to Alzheimer's disease - Your memory and thinking scores fall within a specific range on standard tests (MoCA 16–25; CDR Global 0–1) - If you take Alzheimer's medications (such as donepezil or memantine), you have been on a stable dose for at least 4 weeks - You are able to attend weekly in-person visits at Cedars-Sinai **You may NOT be eligible if...** - You have another significant brain condition (such as epilepsy, Parkinson's disease, or large brain lesions) - You have a history of seizures - You have significant brain scan findings such as extensive white matter changes or many brain bleeds - You are currently pregnant or breastfeeding - You have participated in another clinical trial within the past 30 days - You have severe dementia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPhotobiomodulation

1064nm transcranial photobiomodulation


Locations(1)

CSMC

Los Angeles, California, United States

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NCT07224607


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