Using infrared light to improve memory in people with mild cognitive impairment
A Pilot Study Evaluating the Feasibility, Safety, and Efficacy of the Neuro RX Gamma (Version 2) for the Treatment of Mild Cognitive Impairment (MCI)
This study is testing if using infrared light therapy can help improve memory in people with mild cognitive impairment from Alzheimer's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Unity Health Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06618807 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of photobiomodulation (PBM) therapy on individuals with mild cognitive impairment (MCI) due to Alzheimer's disease. Approximately 60 participants will be recruited to undergo treatment with either an active or sham Neuro RX gamma device over a 12-week period. The device includes a headset and nasal applicator that deliver low-level light therapy aimed at enhancing cognitive function. The study aims to provide a non-invasive alternative to current pharmacological treatments for MCI.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 and older who meet the criteria for MCI and have a Montreal Cognitive Assessment (MoCA) score between 19-25.
Not a fit: Patients with severe cognitive impairment or those unable to tolerate blood draws or the device's application may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a safer, non-invasive option for improving memory and cognitive function in patients with mild cognitive impairment.
How similar studies have performed: While photobiomodulation therapy is a relatively novel approach, preliminary studies have shown promise in similar applications, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 assessments. Participant 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 infrared light therapy treatment. Any reason that, in the opinion of the investigator, might place a participant at unacceptable risk for participation in the trial. Note: \*Participants with contraindications for MRI can still enroll in the trial and participate without undergoing the MRI procedure. However, if participants do not have contraindications, undergoing the MRI is required as part of the trial.
Where this trial is running
Toronto, Ontario
- St. Michael's Hospital, Unity Health Toronto — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Corinne Fischer, MD, FRCP(C)
- Email: Corinne.Fischer@unityhealth.to
- Phone: 416-360-4000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.