RecruitingNot ApplicableNCT06618807

Infrared Light for Memory Loss in Mild Cognitive Impairment (MCI)

A Pilot Study Evaluating the Feasibility, Safety, and Efficacy of the Neuro RX Gamma (Version 2) for the Treatment of Mild Cognitive Impairment (MCI)


Sponsor

Unity Health Toronto

Enrollment

60 participants

Start Date

Jan 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Mild cognitive impairment (MCI) is a transitional risk state that occurs between the normal aging process and Alzheimer's dementia (AD). On average 32% of patients with MCI will progress to dementia, 62% will stay stable, and about 6% will return to normal cognition at subsequent visits. Current treatment for MCI includes cholinesterase inhibitors (donepezil, galantamine and rivastigmine), and NMDA receptor antagonists (memantine) which delay or slow the worsening of symptoms and treat cognitive symptoms (memory loss, confusion, and problems with thinking and reasoning). Despite currently ongoing drug studies and modest clinical benefits of currently approved drug treatments, there continues to remain a need for treatments for long term symptomatic improvement of MCI with fewer and less severe side effects. Photobiomodulation (PBM) therapy also called low-level laser (or light) therapy (LLLT) is a safe, non-invasive, non-thermal (no significant heat is generated) method of therapy which uses either visible red or near-infrared (NIR) light to stimulate, heal and repair damaged or dying tissue cells. This study proposes to use the Neuro RX Gamma device (version 2) to deliver NIR light energy to particular brain regions which are dysfunctional in MCI participants.


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether infrared light therapy delivered to the head can improve memory and thinking in people with mild cognitive impairment (MCI) that is likely due to early Alzheimer's disease. Infrared light is thought to boost cellular energy in brain cells, potentially improving function. This is a non-invasive treatment. **You may be eligible if...** - You are 50 years of age or older - You have been diagnosed with mild cognitive impairment (MCI), with memory and learning problems but still mostly independent in daily activities - Your MCI meets the criteria for being caused by Alzheimer's disease (per NIA-AA guidelines) - Your cognitive score is in the 19–25 range on the Montreal Cognitive Assessment (MoCA) - If you take dementia medications (cholinesterase inhibitors or memantine), your dose has been stable for at least a set period **You may NOT be eligible if...** - Your memory problems are caused by something other than Alzheimer's - You have a history of significant head injury, stroke, or other neurological conditions - You have a serious psychiatric illness - You have a pacemaker or certain other implanted electronic devices near the head Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEActive tPBM device

The Neuro RX Gamma (version 2) delivers a synchronized pulse frequency of 40 Hz from all LED clusters. The gamma pulse frequency of 40 Hz has been demonstrated to attenuate amyloid beta proteins production in the hippocampus and modulate microglial activity resulting in increased scavenging of amyloid beta which may lead to improving cognition in MCI. Finally, the Vielight Neuro RX Gamma (version 2) has been designed to target the delivery of NIR energy to particular brain regions; specifically the default mode network (DMN). The active intervention device proceeds to deliver light to each LED at 40 Hz with a 50% duty cycle for 20 minutes and stops automatically. During the 20 minute treatment the power indicator LED on the controller flashes green at 40 Hz. The operator is notified that the treatment is finished when the power indicator LED on the controller stops flashing and the device beeps 2 times.

DEVICESham device

The sham device delivers infrared light for only a few seconds before stopping. The controller will still show a green light to maintain the study\'s blinding. If the headset is removed, the device will emit a beep and cease functioning.


Locations(1)

St. Michael's Hospital, Unity Health Toronto

Toronto, Ontario, Canada

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NCT06618807


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