NCT07224607Recruiting
Transcranial Photobiomodulation (tPBM) in Alzheimer's Disease Study
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 1 Nov 2025
- Start date
- Sept 2026
- Primary completion date
- Nov 2027
- Lead sponsor
- Cedars-Sinai Medical Center
- Diseases
- Alzheimer disease
- NCT number
- NCT07224607
What you commit to
- Study type: Interventional
- Planned participants: 45
- From Sept 2026 to the primary completion date, Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Presence of significant neurological conditions other than AD (e.g., epilepsy, Parkinson, etc.)
- History of Seizures
- 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.
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 55 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CSMC Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.