Using light therapy to improve memory in people with mild cognitive impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of a photobiomodulation device, the Vielight Neuro RX Gamma, to enhance mitochondrial function in patients with amnestic mild cognitive impairment (aMCI). Participants will receive daily 20-minute sessions of either the active device or a sham device over six weeks, with assessments conducted at baseline and after treatment to evaluate cognitive function and safety. The study aims to determine the effectiveness of this noninvasive therapy in improving memory and overall cognitive health in individuals at risk for Alzheimer's disease.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age is greater than or equal to 50 years old.
* Meets the National Institute on Aging and Alzheimer's Association (NIA-AA) criteria for MCI due to Alzheimer's disease.
* Essentially normal functional activities as derived from the CDR.
* If receiving ongoing cholinesterase inhibitor therapy and/or memantine, must be on a stable dosage for at least the prior 3 months.
* MoCA score between 19 and 25 at screening assessment and impairment in learning and memory domain.

Exclusion Criteria:

* Cannot tolerate blood draws.
* Claustrophobia (fear of small or enclosed spaces), that cannot tolerate MRI scanners.
* A pace-maker or other metal implants that would preclude safe use of MRI.
* DSM 5 diagnosis of alcohol or other substance use disorders within the past 12 months.
* Unstable medical illness, (e.g., uncontrolled diabetes mellitus or hypertension).
* Any history of stroke, seizures, MS, light sensitivity or Lyme disease.
* Any issues with ambulation, vision, or hearing which could, in the opinion of the investigator, interfere with their ability to complete assessments.
* Participant or caregiver does not speak English at a level necessary for the completion of the assessments.
* Has not completed at least a grade eight education, as necessary for the completion of the assessments.
* Currently participating in another clinical research study involving an investigational product.
* History of significant agitation and/or aggression, epileptic seizures.
* Current neurologic disease affecting cognition other than Alzheimer's disease.
* Photosensitivity reactions to sunlight or visible light (polymorphous light eruption, solar urticaria, persistent light reactivity).
* History of recurrent epistaxis within the last 24 weeks or currently taking major anti-coagulants (including warfarin, low molecular weight heparin)
* Increased skin sensitivity at the treatment site including active herpes simplex in the treatment area, history of keloid formation, or history of retinoid use in the past month.
* Pregnant or lactating or planning to become pregnant.
* Currently undergoing light therapy treatment.
* Any reason that, in the opinion of the investigator, might place a participant at unacceptable risk for participation in the trial.

Where it's running

• St Michael's Hospital
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Corinne Fischer, MD — Unity Health Toronto
• Study coordinator: Corinne Fischer, MD
• Email: Corinne.Fischer@unityhealth.to
• Phone: 416-864-5320

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.