Forehead photobiomodulation for people with mild Alzheimer's-related memory problems
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
This study will see if a forehead light treatment (photobiomodulation) can improve thinking and change blood markers in people aged 55–89 with mild cognitive impairment or mild dementia from Alzheimer's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 55 Years to 89 Years |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT07224607 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are people aged 55–89 with a clinical diagnosis of mild cognitive impairment or mild dementia due to probable Alzheimer's (MoCA 16–25, CDR global 0–1), who can attend weekly visits at Cedars-Sinai and are on stable Alzheimer's medications if applicable.
Not a fit: People with moderate to severe dementia, significant other neurological disorders (for example epilepsy or Parkinson disease), a history of seizures, major space-occupying brain lesions or extensive small-vessel disease on imaging, or those unable to attend regular in-person visits are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the treatment could improve executive function and produce favorable changes in blood markers, offering a noninvasive option to help people in early stages of Alzheimer's.
How similar studies have performed: Small pilot studies and preclinical work have reported promising cognitive and physiological effects from transcranial photobiomodulation, but larger randomized trials are still limited and results remain preliminary.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Los Angeles, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.