Forehead photobiomodulation for people with mild Alzheimer's-related memory problems

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with mild cognitive impairment or mild dementia due to probable Alzheimer's will receive repeated sessions of transcranial photobiomodulation (tPBM) applied to the forehead using an FDA-cleared device used off-label. Cognitive testing focused on executive function will be done before and after treatment, and blood samples will be collected to measure inflammatory and neurodegeneration-related biomarkers. The protocol requires weekly in-person visits at Cedars-Sinai and stable doses of any Alzheimer's medications prior to enrollment. Safety and tolerability of the device will also be monitored throughout the course of treatment.

Why it matters

Who can join: the full rules

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 it's running

• Csmc
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Golnaz Yadollahikhales, MD — Cedars Siinai Medical Center Department of Neurology
• Study coordinator: Enrique Vargas Vargas, MD
• Email: enrique.vargas@cshs.org
• Phone: 972-281-7187

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.