Transcranial Photobiomodulation (tPBM) in Alzheimer's Disease Study

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT07224607
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Photobiomodulation — DEVICE
    1064nm transcranial photobiomodulation

Study Details

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.

Key Dates

Start date
Dec 25, 2025
Status verified
Nov 2025
Primary completion
Aug 28, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

NIH Toolbox [ Time Frame: Baseline measurements will be performed prior to intervention, post-treatment (week 5), and lastly at the 3-month follow-up visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
CSMCLos AngelesCalifornia90048
Enrique Vargas, MD
[email protected]
972-281-7187

Find similar trials in Los Angeles, CA

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
CSMC· Los Angeles, CA

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