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Alzheimer's DiseaseNCT07224607

Transcranial Photobiomodulation (tPBM) in Alzheimer's Disease Study

A study testing Photobiomodulation in people with Alzheimer's Disease, run by Cedars-Sinai Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 89 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
Photobiomodulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
1 siteUnited States
Study dates
1 Sep 2026to 30 Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Enrique Vargas Vargas, MD contact

972-281-7187

enrique.vargas@cshs.org

Golnaz Yadollahikhales, MD contact

310-385-6016

Golnaz.Yadollahikhales@cshs.org

United States1 site, 1 recruiting

  • CSMC

    Los Angeles, California, 90048

    Enrique Vargas, MD, 972-281-7187, enrique.vargas@cshs.org

    Recruiting

Other trials in United States

About this study

Official 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

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.

Being tested
Photobiomodulation
Keywords
photobiomodulation, PBM, Alzheimer's Disease, Dementia, Mild cognitive impairment, MCI, 1064nm
Medical subject headings
Alzheimer Disease, Dementia, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PhotobiomodulationDevice

    1064nm transcranial photobiomodulation

Study groups in NCT07224607
Study groupRoleWhat they receive
Active photobiomodulationExperimental1064nm photobiomodulation to be applied for 8 minutes total each session
Receives: Device: Photobiomodulation
ShamSham comparatoronly 5 seconds of photobiomodulation, to account for small amount of participants who reported an initial warm sensation upon stimulation
Receives: Device: Photobiomodulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Secondary outcomes (6)

  1. Glial Fibrillary Acidic Protein (GFAP)

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

    Measured: Will be performed at baseline and at 3 month follow up

  2. Neurofilament Light Chain (NfL)

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

    Measured: Baseline and 3-month follow up

  3. Total Tau

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

    Measured: Baseline and 3-month follow up

  4. Interferon-γ (IFN-γ)

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

    Measured: Baseline and 3-month follow up

  5. Interleukin-1β (IL-1β)

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

    Measured: Baseline and 3-month follow up

  6. Tumor Necrosis Factor-α (TNF-α)

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

    Measured: Baseline and 3-month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2025
  2. Study start1 Sep 2026
  3. Primary completion28 Nov 2027 (estimated)
  4. Study completion30 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07224607
Sponsor's protocol ID
STUDY00004349
Status last verified
Nov 2025
First submitted
1 Nov 2025
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: All IPD that underlie results in a publication

Publications

  • 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.

    PubMed 35847661

  • 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.

    PubMed 36967820

  • 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.

    PubMed 30474306

  • 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.

    PubMed 37298224

  • 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

  • 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.

    PubMed 28466195

  • 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.

    PubMed 37972955

Questions about this trial

What is this clinical trial studying?

A study testing Photobiomodulation in people with Alzheimer's Disease, run by Cedars-Sinai Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Enrique Vargas Vargas, MD (972-281-7187, enrique.vargas@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07224607, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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