Actively Recruiting
Infrared Light for Memory Loss in Mild Cognitive Impairment (MCI)
Led by Unity Health Toronto · Updated on 2025-12-05
60
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Infrared Light for Memory Loss in Mild Cognitive Impairment (MCI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 years or older
- Diagnosis of mild cognitive impairment due to Alzheimer's disease according to National Institute on Aging and Alzheimer's Association criteria
- Cognitive concern reported by the participant, informant, or clinician
- Montreal Cognitive Assessment (MoCA) score between 19 and 25 with memory and learning impairment
- Essentially normal daily functioning based on Clinical Dementia Rating Scale
- Stable dose of cholinesterase inhibitors and/or memantine for at least 3 months if currently on these medications
- Ability to complete study assessments in English with at least eighth-grade education
You will not qualify if you...
- Unable to tolerate blood draws
- Claustrophobia preventing MRI use
- Presence of pacemaker or metal implants incompatible with MRI
- Alcohol or substance use disorder in past 12 months
- Unstable medical conditions such as uncontrolled diabetes or hypertension
- History of stroke, seizures, multiple sclerosis, or Lyme disease
- Problems with walking, vision, or hearing that interfere with assessments
- Insufficient English proficiency or less than eighth-grade education
- Current participation in another investigational clinical study
- History of severe agitation, aggression, epileptic seizures, or neurologic diseases other than Alzheimer's
- Sensitivity or reactions to sunlight or visible light
- Recent recurrent nosebleeds or use of major blood thinners
- Skin sensitivity or active herpes simplex at treatment site, history of keloids or recent retinoid use
- Pregnant, breastfeeding, or planning pregnancy
- Current infrared light therapy
- Any other condition posing unacceptable risk to participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
St. Michael's Hospital, Unity Health Toronto
Toronto, Ontario, Canada, M5B 1T8
Actively Recruiting
Research Team
C
Corinne Fischer, MD, FRCP(C)
CONTACT
N
Neda Rashidi, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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