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
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 89
Healthy Volunteers: f
View:

• Signed and dated informed consent form (either by subject or LAR)

• Willingness and ability to comply with all study procedures

• Age 55 to 89 years, inclusive

• Clinical diagnosis of Mild Cognitive Impairment or mild dementia (CDR Global = 0-1; MoCA 16-25) due to probable Alzheimer's disease diagnosis

• Ability to attend in-person sessions at Cedars-Sinai and adhere to weekly visits

• Stable dose of Alzheimer's disease medications (e.g., donepezil, rivastigmine, memantine, galantamine) for at least 4 weeks prior to enrollment, if applicable

Locations
United States
California
CSMC
RECRUITING
Los Angeles
Contact Information
Primary
Enrique Vargas Vargas, MD
enrique.vargas@cshs.org
972-281-7187
Backup
Golnaz Yadollahikhales, MD
Golnaz.Yadollahikhales@cshs.org
310-385-6016
Time Frame
Start Date: 2025-12-25
Estimated Completion Date: 2026-10
Participants
Target number of participants: 45
Treatments
Experimental: Active photobiomodulation
1064nm photobiomodulation to be applied for 8 minutes total each session
Sham_comparator: Sham
only 5 seconds of photobiomodulation, to account for small amount of participants who reported an initial warm sensation upon stimulation
Sponsors
Leads: Cedars-Sinai Medical Center

This content was sourced from clinicaltrials.gov