Neuro RX Gamma for Amnestic Mild Cognitive Impairment (aMCI)
Key facts
- Who runs it
- Unity Health Toronto
- Where
- Canada1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Early phase 1
- People taking part
- 20 people enrolled
- Started
- 28 Mar 2023
- Ended
- 3 Feb 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Neuro RX Gamma device
- Sham Neuro RX Gamma device
- Record updated
- 24 July 2025
Who can take part
- Age
- 50 years to 95 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- 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
Who cannot take part
- A pace-maker or other metal implants that would preclude safe use of MRI
- Currently participating in another clinical research study involving an investigational product
- History of recurrent epistaxis within the last 24 weeks or currently taking major anti-coagulants (including warfarin, low molecular weight heparin)
- Currently undergoing light therapy treatment
- 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, light sensitivity or Lyme disease
- History of significant agitation and/or aggression, epileptic seizures
- Current neurologic disease affecting cognition other than Alzheimer's disease
- 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
- Cannot tolerate blood draws
- Claustrophobia (fear of small or enclosed spaces), that cannot tolerate MRI scanners
- Any issues with ambulation, vision, or hearing which could, in the opinion of the investigator, interfere with their ability to complete assessments
- Participant or caregiver 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
- Photosensitivity reactions to sunlight or visible light (polymorphous light eruption, solar urticaria, persistent light reactivity)
- Pregnant or lactating or planning to become pregnant
- Any reason that, in the opinion of the investigator, might place a participant at unacceptable risk for participation in the trial
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Over 50 million people worldwide are currently living with dementia-a number projected to rise to 152 million by 2050. Mitochondrial dysfunction in the brains of individuals with Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD) has gained increasing attention as a potential mechanism and therapeutic target. However, no effective treatment specifically targeting mitochondrial function is currently available.
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Photobiomodulation (PBM) is an innovative, non-invasive technique that delivers near-infrared light transcranially to the brain. PBM is believed to enhance mitochondrial function-particularly in tissues with high mitochondrial density such as the brain-by reducing oxidative stress and increasing ATP production. It can be safely administered to awake outpatients and does not require general anesthesia or surgical intervention. While preclinical and case studies suggest PBM may be beneficial in AD, the absence of placebo-controlled trials and objective biomarkers has limited understanding of its effectiveness and underlying mechanisms.
Objectives: This pilot feasibility study aims to assess cognitive outcomes and neural correlates associated with PBM in individuals with early amnestic MCI (aMCI). Participants who meet eligibility criteria (n = 20) will undergo a 6-week, home-based PBM intervention using the Neuro Rx Gamma device (6 days/week, 20 minutes/session). Clinical and cognitive assessments, blood sample collection, and structural and resting-state functional MRI scans will be conducted at two time points: baseline and post-treatment. These assessments will enable evaluation of PBM's effects on cognition and brain function, with particular focus on mitochondrial-related mechanisms.
This study offers a unique opportunity to investigate whether PBM can modulate mitochondrial and neural processes associated with cognitive decline in aMCI.
The 2 groups in the trial
- Active Neuro Rx DeviceExisting treatment, for comparison
The active device will deliver light for the 20 minutes session duration.
Treatment: Neuro RX Gamma device
- Sham Neuro Rx DeviceSham treatment, for comparison
The Sham device is indistinguishable from the active device. The sham device will not deliver light for the 20 minutes session duration.
Treatment: Sham Neuro RX Gamma device
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Pilot Study Evaluating the Feasibility, Safety, and Efficacy of the Vielight Neuro RX Gamma for the Treatment of Amnestic Mild Cognitive Impairment (aMCI)
- Record updated
- 24 July 2025