Recruiting

Photobiomodulation

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT07224607

Conditions

Alzheimer's Disease

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Photobiomodulation

Study Details

Brief 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

Study ID

NCT07224607

Start date

Dec 25, 2025

Status verified date

Nov, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Aug 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Presence of significant neurological conditions other than AD (e.g., epilepsy, Parkinson, etc.)
  • History of Seizures
  • If patient holds neuroimaging showing space-occupying lesions
  • If patient holds imaging with Fazekas greater than or equal to 3, more than 2 lacunar infarcts, and/or more than 5 microhemorrhages
  • Current pregnancy or lactation (although unlikely in this population)
  • Participation in another clinical trial or investigational drug within the past 30 days
  • Active use of illicit substances or non-prescribed psychoactive drugs within the past 30 days.
  • Severe dementia due to Alzheimer's disease or another etiology
  • Physical or mental impairment that prevents the participant from complying with the cognitive testing battery.

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Photobiomodulation

1064nm transcranial photobiomodulation

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 and Locations

Central contacts

Enrique Vargas Vargas, MD

972-281-7187enrique.vargas@cshs.org

Golnaz Yadollahikhales, MD

310-385-6016Golnaz.Yadollahikhales@cshs.org

Locations

CSMC

Recruiting

Los Angeles, California, United States, 90048

Contacts

Enrique Vargas, MD

972-281-7187enrique.vargas@cshs.org

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Nov 19, 2025

Last verified

Nov, 2025

Keywords

  • photobiomodulation
  • PBM
  • Alzheimer's Disease
  • Dementia
  • Mild cognitive impairment
  • MCI
  • 1064nm

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2025-11-19.