NCT07224607

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 55 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DEVICE	Photobiomodulation	1064nm transcranial photobiomodulation

Timeline

• Start date: 2025-12-25
• Primary completion: 2026-08-28
• Completion: 2026-10-01
• First posted: 2025-11-04
• Last updated: 2025-11-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study