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NCT Number: NCT07224607

Transcranial Photobiomodulation (tPBM) in Alzheimer's Disease Study

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.

Recruiting

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CSMC

Los Angeles, California, 90048, United States

Location status: Recruiting

Location contact

Enrique Vargas, MD

CONTACT

[email protected]

972-281-7187

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Photobiomodulation

Device

1064nm transcranial photobiomodulation

Primary outcomes

  1. 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

    Three validated NIH Toolbox tasks:

    • Dimensional Change Card Sort Task (measure of cognitive flexibility)
    • Flanker Inhibitory Control and Attention Test (a measure of inhibitory control and selective attention),
    • Visual Reasoning Test (non-verbal and visual reasoning)

Secondary outcomes

  1. Glial Fibrillary Acidic Protein (GFAP)

    Time frame: Will be performed at baseline and at 3 month follow up

    Plasma GFAP concentration (pg/ml) measure using the S-PLEX Assay

  2. Neurofilament Light Chain (NfL)

    Time frame: Baseline and 3-month follow up

    Plasma Neurofilament Light Chain (NfL) concentration (pg/ml) measure using the S-PLEX Assay

  3. Total Tau

    Time frame: Baseline and 3-month follow up

    Plasma total tau concentration (pg/ml) measure using the S-PLEX Assay

  4. Interferon-γ (IFN-γ)

    Time frame: Baseline and 3-month follow up

    Plasma GFAP concentration (pg/ml) measure using the V-PLEX Assay

  5. Interleukin-1β (IL-1β)

    Time frame: Baseline and 3-month follow up

    Plasma IL-1β concentration measured using the V-PLEX assay

  6. Tumor Necrosis Factor-α (TNF-α)

    Time frame: Baseline and 3-month follow up

    Plasma TNF-α concentration (pg/ml) measured using the V-PLEX assay

Study contacts

Contact information is provided by the study sponsor or research team.

Enrique Vargas Vargas, MD

CONTACT

[email protected]

972-281-7187

Golnaz Yadollahikhales, MD

CONTACT

[email protected]

310-385-6016

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 4, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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