45 Participants Needed

Photobiomodulation for Alzheimer's Disease

EV
GY
Overseen ByGolnaz Yadollahikhales, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Cedars-Sinai Medical Center
Must be taking: Alzheimer's medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a special light treatment, called photobiomodulation, can aid those with memory problems due to Mild Cognitive Impairment or Mild Dementia from Alzheimer's disease. The treatment involves applying light to the forehead to determine if it improves thinking skills and affects blood signals related to inflammation and brain health. Participants will undergo cognitive tests and provide blood samples before and after the treatment. Individuals with Alzheimer's who can attend in-person sessions and are on stable medication may be suitable candidates.

As an unphased trial, this study provides a unique opportunity to explore a novel treatment approach for memory issues.

Do I need to stop my current medications for the trial?

The trial requires that you have been on a stable dose of Alzheimer's medications for at least 4 weeks before joining. It doesn't specify stopping other medications, so you may not need to stop them.

What prior data suggests that this photobiomodulation device is safe for use on the forehead?

Research has shown that photobiomodulation, a type of light therapy, is generally safe. Studies have found that this treatment can reduce swelling and improve blood flow in the brain, which might benefit those with memory problems, such as Alzheimer's disease.

One study suggested that photobiomodulation is safe and may aid some aspects of thinking and memory. However, this study included only a small number of participants. The FDA has approved the device used in this therapy for other purposes, such as pain relief and improved blood flow, but it is being applied in a new way for this study.

Overall, while the treatment appears well-tolerated, more research is needed to fully understand its safety and effectiveness for memory issues related to Alzheimer's.12345

Why are researchers excited about this trial?

Researchers are excited about photobiomodulation for Alzheimer's disease because it offers a novel approach compared to existing treatments. Unlike standard therapies that often rely on drugs to manage symptoms, photobiomodulation uses a specific wavelength of light (1064nm) to potentially influence brain activity and reduce the effects of Alzheimer's. This non-invasive method could provide a new avenue for treatment with fewer side effects and a different mechanism of action by potentially promoting cellular repair and reducing inflammation in the brain. This innovative technique could offer hope for better management of Alzheimer's symptoms.

What evidence suggests that photobiomodulation might be an effective treatment for Alzheimer's disease?

Research has shown that photobiomodulation therapy (PBMT) might help reduce the buildup of beta-amyloid in the brain, often linked to Alzheimer's disease. Some studies suggest this therapy could also address related brain issues in Alzheimer's treatment. While not all research indicates major improvements in symptoms like anxiety, evidence suggests PBMT could be a safe and effective treatment option for Alzheimer's. In this trial, participants will receive either active photobiomodulation or a sham treatment. The active treatment uses a special light on the forehead, possibly improving memory and thinking skills. Overall, early findings suggest PBMT could be a promising non-invasive therapy for Alzheimer's.36789

Who Is on the Research Team?

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Golnaz Yadollahikhales, MD

Principal Investigator

Cedars Siinai Medical Center Department of Neurology

Are You a Good Fit for This Trial?

This trial is for individuals with memory issues due to Mild Cognitive Impairment or Mild Dementia from Alzheimer's. Participants should be comfortable with using an off-label medical device on their forehead and providing blood samples before and after treatment.

Inclusion Criteria

Ability to attend in-person sessions at Cedars-Sinai and adhere to weekly visits
Signed and dated informed consent form (either by subject or LAR)
My Alzheimer's medication dose has been stable for at least 4 weeks.
See 3 more

Exclusion Criteria

Physical or mental impairment that prevents the participant from complying with the cognitive testing battery
Neuroimaging showing space-occupying lesions
Imaging with Fazekas greater than or equal to 3, more than 2 lacunar infarcts, and/or more than 5 microhemorrhages
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive photobiomodulation treatment applied to the forehead using an FDA-cleared medical device

5 weeks
Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including cognitive tests and biomarker analysis

3 months
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Photobiomodulation
Trial Overview The study tests if photobiomodulation, a special light treatment applied to the forehead, can improve executive function in people with cognitive impairments. It also examines changes in inflammatory and neurodegeneration markers in the blood.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active photobiomodulationExperimental Treatment1 Intervention
Group II: ShamPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials
523
Recruited
165,000+

Citations

an overview of photobiomodulation for Alzheimer's treatmentPhotobiomodulation therapy (PBMT) was found to reduce the deposition and overload of beta-amyloid in the brain, especially in Alzheimer's disease (AD).
Photobiomodulation in experimental models of Alzheimer's ...In this review, we discuss the potential of photobiomodulation (PBM) for preventing and alleviating AD-associated pathologies, with a focus on the biological ...
Photobiomodulation's potential as a non-invasive therapy ...In contrast to the majority of prior research, our study did not find a significant improvement in anxiety levels among Alzheimer's patients undergoing PBM ...
A randomized, blinded study of photobiomodulation in ...We aimed to evaluate the potential beneficial effect of PBM on Alzheimer's disease (AD) using behavioral and histological readouts from a well-established ...
Photobiomodulation as a Potential Treatment for ...Conclusions: The findings underscore the significant potential of PBM as a safe and effective alternative treatment for Alzheimer's disease, ...
Photobiomodulation for Alzheimer's Disease - PubMed CentralThis review covers the mechanistic action of photobiomodulation therapy against Alzheimer's disease at a cellular level. Safe and effective ...
a potential treatment in Alzheimer's and Parkinson's diseasesBrain photobiomodulation (bPBM) reduces oxidative stress and inflammation, increases cerebral blood flow and enhance neurogenesis and synaptogenesis.
Photobiomodulation for Improving Brain Function in ...Photobiomodulation (PBM) describes a kind of light therapy that uses red or near-infrared light to stimulate, heal, regenerate, and protect tissue that has ...
Light therapy and dementiaA further study in 2018 also suggested that the device is safe and may improve some measures of cognitive function. The very small number of participants and ...
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