Actively Recruiting
Transcranial Photobiomodulation (tPBM) in Alzheimer's Disease Study
Led by Cedars-Sinai Medical Center · Updated on 2025-11-19
45
Participants Needed
1
Research Sites
40 weeks
Total Duration
On this page
AI-Summary
What this Trial 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. 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
Official Title
Transcranial Photobiomodulation (tPBM) in Alzheimer's Disease Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form (either by subject or legal representative)
- 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
- Ability to attend in-person sessions at Cedars-Sinai and adhere to weekly visits
- Stable dose of Alzheimer's disease medications for at least 4 weeks prior to enrollment, if applicable
You will not qualify if you...
- Presence of significant neurological conditions other than Alzheimer's disease (e.g., epilepsy, Parkinson's disease)
- History of seizures
- Neuroimaging showing space-occupying lesions
- Imaging with Fazekas score ≥ 3, more than 2 lacunar infarcts, and/or more than 5 microhemorrhages
- Current pregnancy or lactation
- Participation in another clinical trial or investigational drug use 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 cause
- Physical or mental impairment preventing compliance with cognitive testing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CSMC
Los Angeles, California, United States, 90048
Actively Recruiting
Research Team
E
Enrique Vargas Vargas, MD
CONTACT
G
Golnaz Yadollahikhales, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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