NCT07224607 · Cedars-Sinai Medical Center
Transcranial Photobiomodulation (tPBM) in Alzheimer's Disease Study
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Photobiomodulation
1064nm transcranial photobiomodulation
Primary outcome measures
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: 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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Los Angeles, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 19, 2025 · Source of record for eligibility and locations