No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
55 – 89
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
45 (estimated)
Sponsor
Cedars-Sinai Medical Center · Other
Who this trial is looking for
This trial is looking for people aged 55 to 89 with memory problems related to Alzheimer's disease. Participants will receive a special light treatment on their forehead and undergo cognitive tests and blood sample collection before and after the treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I can attend in-person sessions at Cedars-Sinai every week.
I am between 55 and 89 years old.
I have been diagnosed with Mild Cognitive Impairment or mild dementia due to probable Alzheimer's disease.
I have signed an informed consent form.
I can comply with all study procedures.
I have been on a stable dose of Alzheimer's disease medications for at least 4 weeks, if applicable.
You may not be able to join if
I have a significant neurological condition other than Alzheimer's disease.
I have a history of seizures.
I have imaging results showing space-occupying lesions.
I have imaging with a Fazekas score greater than or equal to 3.
I am currently pregnant or breastfeeding.
I have participated in another clinical trial in the past 30 days.
I use illegal substances or non-prescribed psychoactive drugs.
I have severe dementia due to Alzheimer's disease or another cause.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 join…
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.
Trial Locations
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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 Alz…
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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