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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years to 89 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "We will also collect blood samples before and after treatment."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether light applied to the forehead can help people ages 55–89 with mild memory or thinking problems due to likely Alzheimer's disease. It looks at planning and thinking skills and blood signs of swelling and nerve cell damage. The device is FDA-cleared for heat treatment to relieve pain, but not for this study's use.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You or your legally authorized representative must sign and date a consent form.
  • You must be willing and able to follow all study steps.
  • You must be 55–89 years old.
  • You must have mild cognitive impairment (mild memory or thinking problems) or mild dementia due to likely Alzheimer's disease, with required test scores: CDR 0–1 and MoCA 16–25.
  • You must be able to attend weekly visits in person at Cedars-Sinai.
  • If you take Alzheimer's medicines, your dose must be unchanged for at least 4 weeks before joining.

Who can't join

  • You have a major brain or nerve condition other than Alzheimer's disease, such as Parkinson's disease, or a history of seizures.
  • Your brain scans show a growth or other area taking up space in the brain.
  • Your brain scans show severe changes in the brain's white matter (Fazekas score of 3 or higher), more than 2 small strokes, or more than 5 tiny areas of bleeding.
  • You are pregnant or breastfeeding.
  • You took part in another clinical trial or used an experimental drug within the past 30 days.
  • You used illegal substances or non-prescribed drugs that affect mood or thinking within the past 30 days.
  • You have severe dementia from Alzheimer's disease or another cause.
  • A physical or mental condition keeps you from completing the thinking and memory tests.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

CA