Transcranial Photobiomodulation (tPBM) in Alzheimer's Disease Study

NCT ID: NCT07224607

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-25
• Study Completion Date: 2026-10-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active photobiomodulation

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

Group Type: EXPERIMENTAL

Photobiomodulation

Intervention Type: DEVICE

1064nm transcranial photobiomodulation

Sham

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

Group Type: SHAM_COMPARATOR

Photobiomodulation

Intervention Type: DEVICE

1064nm transcranial photobiomodulation

Interventions

Photobiomodulation

1064nm transcranial photobiomodulation

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Golnaz Yadollahikhales

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Golnaz Yadollahikhales, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars Siinai Medical Center Department of Neurology

Locations

CSMC

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Enrique Vargas Vargas, MD

Role: CONTACT

enrique.vargas@cshs.org

972-281-7187

Golnaz Yadollahikhales, MD

Role: CONTACT

Golnaz.Yadollahikhales@cshs.org

310-385-6016

Facility Contacts

Enrique Vargas, MD

Role: primary

enrique.vargas@cshs.org

972-281-7187

References

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.

Reference Type: BACKGROUND

PMID: 35847661 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36967820 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30474306 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37298224 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 28466195 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37972955 (View on PubMed)

Other Identifiers

STUDY00004349

Identifier Type: -

Identifier Source: org_study_id