Infrared Light for Memory Loss in Mild Cognitive Impairment (MCI) (NCT06618807) | Clinical Trial Compass
RecruitingNot Applicable
Infrared Light for Memory Loss in Mild Cognitive Impairment (MCI)
Canada60 participantsStarted 2025-01-10
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Individuals who meet the criteria for MCI of 1) cognitive concern by the subject, informant, or clinician; 2) Montreal Cognitive Assessment (MoCA) score between 19-25 and impairment in learning and memory domain; 3) essentially normal functional activities as derived from the Clinical Dementia Rating Scale (CDR) and 4) the National Institute on Aging and Alzheimer's Association (NIA-AA) criteria for MCI due to Alzheimer's disease. , 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, or Lyme disease. Any issues with ambulation, vision, or hearing which could, in the opinion of the investigator, interfere with their ability to complete…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is listed as 'Phase NA,' meaning it may be an early feasibility or device study rather than a late-stage efficacy trial, what does that mean for how much is already known about whether infrared light actually helps with memory loss?
2The trial is specifically for people with Mild Cognitive Impairment due to Alzheimer's disease — how would my doctor determine whether my diagnosis fits that specific definition, since MCI can have different underlying causes?
3The primary outcome being measured is cognition — what cognitive tests or tools would I be asked to do during the trial, and how much of my time and energy would that realistically require?
4Are there any known risks or side effects from the type of infrared light device being used in this study that I should weigh before deciding whether to discuss enrollment with my care team?
5Given that this is a recruiting trial with an emerging technology, would my doctor recommend first exploring or completing any standard-of-care treatments for MCI before considering whether this trial might be a fit for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cognition
Timeframe: Change from pre- to post-treatment (week 0, week 9)