Neuro RX Gamma for Mild Cognitive Impairment
Trial Summary
What is the purpose of this trial?
There are over 50 million people living with dementia, and by 2050, the number is expected to rise to 152 million worldwide. Mitochondrial dysfunction in the brain of MCI and AD patients is gaining prominence as a potential mechanism and thus treatment target. However, an effective therapy targeting mitochondrial function, is still missing. Photobiomodulation (PBM), is an innovative noninvasive technique that delivers transcranial near infrared light to the brain. PBM is thought to play a key role in enhancing mitochondrial function \[especially in tissues with a high number of mitochondria (e.g.,brain)\], by reducing oxidative stress and increasing ATP levels. PBM can be safely administered to awake outpatients and does not require general anesthesia or surgical implantation. Recent animal studies, and case studies suggest that PBM is a promising therapy for AD. However, due to the lack of placebo controls and objective blood and neuroimaging biomarkers, the effectiveness and mechanism of action of PBM (via enhancing mitochondrial function) in AD remains to be studied. Objectives: The investigators aim to evaluate cognitive changes and neural correlates associated with PBM in early amnestic MCI (aMCI) during a pilot feasibility study. Participants who meet study criteria will undergo a 6-week trial of home-used PBM using the Neuro Rx Gamma 6days/week, 20 minutes per session (n=20). All patients will undergo clinical and cognitive assessment, blood sample collection, and structural and resting state functional MRI scans in two timepoints; pre and post treatment. The longitudinal nature of the study will allow investigation of the PBM effect and its' neural correlates in aMCI via enhancement of mitochondrial function. The present study provides a unique opportunity to investigate the mitochondrial and neural mechanisms that may be involved in prevention or delay of cognitive decline in aMCI.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on cholinesterase inhibitors or memantine, you must have been on a stable dose for at least 3 months before joining the trial.
How is the treatment Neuro RX Gamma different from other treatments for mild cognitive impairment?
Neuro RX Gamma is unique because it uses light therapy, specifically near-infrared light, to stimulate brain activity, which is different from other treatments that often involve medications or supplements. This non-invasive approach aims to improve cognitive function by enhancing brain health directly through light exposure.12345
Research Team
Corinne Fischer, MD
Principal Investigator
Unity Health Toronto
Eligibility Criteria
This trial is for people over 50 with mild cognitive impairment due to Alzheimer's, who function normally in daily life and have a specific score range on the MoCA test. They must be stable on certain dementia medications if used, and have a caregiver to help with home treatments. Excluded are those with substance abuse issues, unstable illnesses, non-English speakers without grade eight education level, or involvement in other drug trials.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a 6-week trial of home-used photobiomodulation using the Neuro Rx Gamma device, 6 days/week, 20 minutes per session
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Neuro RX Gamma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Unity Health Toronto
Lead Sponsor