Neuro RX Gamma for Mild Cognitive Impairment

Overseen By Neda Art Rashidi-Ranjbar, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Unity Health Toronto

Must be taking: Cholinesterase inhibitors, Memantine

Must not be taking: Major anti-coagulants

Disqualifiers: Stroke, Seizures, Uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

20 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

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.

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

MoCA score between 19 and 25 at screening assessment and impairment in learning and memory domain

Essentially normal functional activities as derived from the CDR

Meets the National Institute on Aging and Alzheimer's Association (NIA-AA) criteria for MCI due to Alzheimer's disease

Exclusion Criteria

Cannot tolerate blood draws

Claustrophobia (fear of small or enclosed spaces) that cannot tolerate MRI scanners

I have a history of stroke, seizures, MS, light sensitivity, or Lyme disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo a 6-week trial of home-used photobiomodulation using the Neuro Rx Gamma device, 6 days/week, 20 minutes per session

6 weeks

2 visits (in-person) at baseline and 6 weeks, 1 visit (remote or in-person) at week 3

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Neuro RX Gamma

Trial Overview The Neuro RX Gamma device uses near-infrared light therapy thought to improve brain function by enhancing mitochondrial activity. Participants will use this device at home for six weeks. The study includes clinical assessments and MRI scans before and after treatment to evaluate changes in cognition and brain activity.

Participant Groups

Group I: Active Neuro Rx Device Active Control 1 Intervention

The active device will deliver light for the 20 minutes session duration.

Group II: Sham Neuro Rx Device Placebo Group 1 Intervention

The Sham device is indistinguishable from the active device. The sham device will not deliver light for the 20 minutes session duration.

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+

Findings from Research

In a study involving 2,048 subjects with mild cognitive impairment, galantamine did not significantly reduce the rate of conversion to dementia compared to placebo over 24 months.

Galantamine was generally well tolerated, with nausea being the most common side effect, affecting 29% of participants, while the overall mortality rate was slightly higher in the galantamine group (1.4%) compared to placebo (0.3%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of galantamine in subjects with mild cognitive impairment. Winblad, B., Gauthier, S., Scinto, L., et al.[2022]

This study will evaluate the efficacy and safety of a combined treatment of electroacupuncture and computer-based cognitive rehabilitation (EA-CCR) for mild cognitive impairment (MCI) in a randomized controlled trial involving 36 participants over 8 weeks.

The primary outcome will be measured by improvements in cognitive function using the Alzheimer's Disease Assessment Scale, with additional assessments for depression and daily living activities, aiming to provide preliminary evidence for this innovative therapy approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of electroacupuncture combined with computer-based cognitive rehabilitation on mild cognitive impairment: study protocol for a pilot randomized controlled trial. Kim, JH., Han, JY., Park, GC., et al.[2020]

In a study of 55 patients with mild cognitive impairment (MCI), those who consumed higher amounts of cocoa polyphenols showed significantly less cognitive decline over one year compared to those who did not, suggesting a potential protective effect against worsening cognition.

Among patients who did not worsen, 46.2% experienced cognitive improvement and were treated with cocoa polyphenols, indicating that dietary supplementation may help in managing MCI and delaying progression to dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Cocoa Polyphenols in the Treatment of Mild Cognitive Impairment: A Retrospective Study. Calabrò, RS., De Cola, MC., Gervasi, G., et al.[2023]

In a study of 72 patients with mild cognitive impairment (MCI), MLC601 demonstrated significant improvements in cognitive function compared to placebo, as measured by the Mini-Mental State Examination (MMSE) and Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) scores.

MLC601 was well-tolerated, with only 14.7% of patients reporting minor adverse events, primarily gastrointestinal, and none leading to withdrawal from the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of MLC601 in the Treatment of Mild Cognitive Impairment: A Pilot, Randomized, Double-Blind, Placebo-Controlled Study. Pakdaman, H., Amini Harandi, A., Abbasi, M., et al.[2022]

In a study of 25 patients with chronic brain ischemia and moderate cognitive impairment, cereton demonstrated a significant positive effect on cognitive function, with noticeable improvements starting around day 5 and more stable effects by day 15.

Cereton was well-tolerated by patients and positively impacted their quality of life, with clinicians observing moderate to marked improvements in cognitive function by the end of the treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of cereton in patients with chronic brain ischemia and moderate cognitive impairment]. Pizova, NV.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of galantamine in subjects with mild cognitive impairment. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effects of electroacupuncture combined with computer-based cognitive rehabilitation on mild cognitive impairment: study protocol for a pilot randomized controlled trial. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Efficacy of Cocoa Polyphenols in the Treatment of Mild Cognitive Impairment: A Retrospective Study. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of MLC601 in the Treatment of Mild Cognitive Impairment: A Pilot, Randomized, Double-Blind, Placebo-Controlled Study. [2022]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The use of cereton in patients with chronic brain ischemia and moderate cognitive impairment]. [2017]