Transcranial Photobiomodulation (tPBM) for Alzheimer's Disease

This study is looking into whether a special light treatment called transcranial photobiomodulation (tPBM) can help people with memory problems like Mild Cognitive Impairment or mild dementia due to Alzheimer's disease. The treatment uses a device that shines 1064nm light on the forehead. This device is FDA-cleared for other uses, but in this study, it's being used in a new way to see if it can improve memory. You may be able to join if you are between 55 and 89 years old, have a diagnosis of Mild Cognitive Impairment or mild dementia due to probable Alzheimer's disease, and can attend in-person sessions. The study will measure changes in your cognitive abilities using the NIH Toolbox to see if the treatment is successful. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 45 participants. The study will test the effects of transcranial photobiomodulation (tPBM).
What's involved
You would have measurements taken before the treatment, after 5 weeks of treatment, and then again at a 3-month follow-up visit. You must be able to attend in-person sessions at Cedars-Sinai.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a follow-up visit 3 months after the treatment ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07224607

Transcranial Photobiomodulation (tPBM) in Alzheimer's Disease Study

Recruiting
NAAges 55–89InterventionalTreatment
Cedars-Sinai Medical Center
~45 participants
Updated 2025-11-19 on ClinicalTrials.gov
What's tested:Photobiomodulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
NIH Toolbox
Measured over Baseline measurements will be performed prior to intervention, post-treatment (week 5), and lastly at the 3-month follow-up visit
Alzheimer's Disease
1 sites across 1 states
California1
  • Golnaz Yadollahikhales, MD · PRINCIPAL_INVESTIGATOR · Cedars Siinai Medical Center Department of Neurology

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Eligibility criteria

Inclusion

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

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.
  • NIH ToolboxBaseline 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: 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)