What is the Purpose of this Study?
The purpose of this study is to determine whether a special light treatment called photobiomodulation can help people with memory problems due to Alzheimer’s disease. Researchers want to learn whether the light treatment can improve memory and thinking, as well as whether it changes certain signals in the blood that are related to brain degeneration. Participants will receive light applied to the forehead for a total of 8 minutes once a week for 5 light treatment sessions. Before and after receiving the light, participants will answer a questionnaire about their memory and thinking. Participants will provide blood samples at the first visit and again at a follow-up visit 3 months after the light treatment sessions are completed. The light given to the forehead uses a medical device that is approved by the U.S. Food and Drug Administration (FDA) for other conditions, but its use is considered experimental in this study.
Eligibility
- * 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
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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.
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Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
A longitudinal study investigating the effects of photobiomodulation on cognitive function and Alzheimer's Disease -related biomarkers in individuals with mild cognitive impairment or Mild Dementia due to AD.