Transcranial Photobiomodulation (tPBM) in Alzheimer's Disease Study

NCT07224607 | Recruiting FDA Device

• 1 other identifier: STUDY00004349
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• NIH Toolbox

  Three validated NIH Toolbox tasks: 1. Dimensional Change Card Sort Task (measure of cognitive flexibility) 2. Flanker Inhibitory Control and Attention Test (a measure of inhibitory control and selective attention), 3. Visual Reasoning Test (non-verbal and visual reasoning)

  Baseline measurements will be performed prior to intervention, post-treatment (week 5), and lastly at the 3-month follow-up visit

Secondary Outcomes (6)

• Glial Fibrillary Acidic Protein (GFAP)

  Will be performed at baseline and at 3 month follow up

• Neurofilament Light Chain (NfL)

  Baseline and 3-month follow up

• Total Tau

  Baseline and 3-month follow up

• Interferon-γ (IFN-γ)

  Baseline and 3-month follow up

• Interleukin-1β (IL-1β)

  Baseline and 3-month follow up

Study Arms (2)

Active photobiomodulation

EXPERIMENTAL

1064nm photobiomodulation to be applied for 8 minutes total each session

Device: Photobiomodulation

Sham

SHAM COMPARATOR

only 5 seconds of photobiomodulation, to account for small amount of participants who reported an initial warm sensation upon stimulation

Device: Photobiomodulation

Interventions

Photobiomodulation DEVICE

1064nm transcranial photobiomodulation

Active photobiomodulation; Sham

Eligibility Criteria

• Age: 55 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

CSMC

Los Angeles, California, 90048, United States

RECRUITING

Related Publications (7)

• Zhu G, Tong Q, Ye X, Li J, Zhou L, Sun P, Liang F, Zhong S, Cheng R, Zhang J. Phototherapy for Cognitive Function in Patients With Dementia: A Systematic Review and Meta-Analysis. Front Aging Neurosci. 2022 Jun 30;14:936489. doi: 10.3389/fnagi.2022.936489. eCollection 2022.

  PMID: 35847661 BACKGROUND

• Luo G, Zhang J, Song Z, Wang Y, Wang X, Qu H, Wang F, Liu C, Gao F. Effectiveness of non-pharmacological therapies on cognitive function in patients with dementia-A network meta-analysis of randomized controlled trials. Front Aging Neurosci. 2023 Mar 2;15:1131744. doi: 10.3389/fnagi.2023.1131744. eCollection 2023.

  PMID: 36967820 BACKGROUND

• Chan AS, Lee TL, Yeung MK, Hamblin MR. Photobiomodulation improves the frontal cognitive function of older adults. Int J Geriatr Psychiatry. 2019 Feb;34(2):369-377. doi: 10.1002/gps.5039. Epub 2018 Dec 10.

  PMID: 30474306 BACKGROUND

• Su M, Nizamutdinov D, Liu H, Huang JH. Recent Mechanisms of Neurodegeneration and Photobiomodulation in the Context of Alzheimer's Disease. Int J Mol Sci. 2023 May 25;24(11):9272. doi: 10.3390/ijms24119272.

  PMID: 37298224 BACKGROUND

• Gonzalez-Lima, F. (2021). Neuroprotection and Neurocognitive Augmentation by Photobiomodulation. In: Opris, I., A. Lebedev, M., F. Casanova, M. (eds) Modern Approaches to Augmentation of Brain Function. Contemporary Clinical Neuroscience. Springer, Cham. https://doi.org/10.1007/978-3-030-54564-2_9

  BACKGROUND

• Vargas E, Barrett DW, Saucedo CL, Huang LD, Abraham JA, Tanaka H, Haley AP, Gonzalez-Lima F. Beneficial neurocognitive effects of transcranial laser in older adults. Lasers Med Sci. 2017 Jul;32(5):1153-1162. doi: 10.1007/s10103-017-2221-y. Epub 2017 May 2.

  PMID: 28466195 BACKGROUND

• Boyer D, Hu A, Warrow D, Xavier S, Gonzalez V, Lad E, Rosen RB, Do D, Schneiderman T, Ho A, Munk MR, Jaffe G, Tedford SE, Croissant CL, Walker M, Ruckert R, Tedford CE. LIGHTSITE III: 13-Month Efficacy and Safety Evaluation of Multiwavelength Photobiomodulation in Nonexudative (Dry) Age-Related Macular Degeneration Using the Lumithera Valeda Light Delivery System. Retina. 2024 Mar 1;44(3):487-497. doi: 10.1097/IAE.0000000000003980.

  PMID: 37972955 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Cognitive Dysfunction

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Golnaz Yadollahikhales, MD

  Cedars Siinai Medical Center Department of Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrique Vargas Vargas, MD

CONTACT

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

Golnaz Yadollahikhales, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 1, 2025
• First Posted: November 4, 2025
• Study Start: December 25, 2025
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 6 months after publication all IPD and supporting information will be made available
• Access Criteria: All information regarding participants' data on primary and secondary outcome measures that will be used in publication

Locations

US (1)