Neuro RX Gamma for Mild Cognitive Impairment

Overseen By Neda Art Rashidi-Ranjbar, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new, non-invasive light therapy called Photobiomodulation (PBM) that might improve brain function in people with early memory problems related to Alzheimer's disease. The goal is to determine if PBM can boost brain health by enhancing the function of mitochondria, which act as tiny power plants in cells and can be affected in Alzheimer's. Participants will use a device called Neuro RX Gamma at home for 20 minutes a day, six days a week, over six weeks. This trial suits individuals with mild memory issues who are stable on current Alzheimer's medications. As an Early Phase 1 trial, this research focuses on understanding how PBM works in people, offering participants the opportunity to be among the first to experience this innovative treatment.

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.

What prior data suggests that the Neuro RX Gamma device is safe for individuals with mild cognitive impairment?

Research shows that photobiomodulation (PBM), like the treatment used in the Neuro RX Gamma device, has undergone testing before. Studies have found that PBM is generally well-tolerated. For instance, in past trials for conditions such as post-COVID cognitive impairment, participants usually did not experience serious side effects. This technique is non-invasive, avoiding surgery or anesthesia, which reduces the risk of complications.

While researchers continue to study the treatment, its use of light to improve brain function suggests it might be safe. As this is an early phase trial, the primary focus is on ensuring safety. Previous research and the nature of the treatment provide some reassurance about its safety in humans. However, as with any trial, participants should stay informed and discuss any concerns with the research team. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Neuro RX Gamma because it uses light therapy, a novel approach for treating mild cognitive impairment. Unlike current treatments that often rely on medications to manage symptoms, Neuro RX Gamma delivers light directly to the brain in short, 20-minute sessions. This non-invasive technique is believed to stimulate brain activity and improve cognitive function without the side effects associated with drugs. The potential for rapid and safe cognitive enhancement makes this treatment particularly promising.

What evidence suggests that the Neuro RX Gamma device is effective for mild cognitive impairment?

Research suggests that light therapy, known as photobiomodulation (PBM), might enhance brain function in people with mild cognitive impairment (MCI). Studies have shown that PBM, using the Neuro RX Gamma device, can boost thinking skills and brain connections. This trial will compare the effects of an active Neuro RX Gamma device, which delivers light during the session, with a sham device that does not. PBM may improve mitochondrial health, enhancing energy production in cells. By applying near-infrared light to the brain, PBM might reduce damage from harmful molecules and increase cellular energy production. Although direct human trials remain limited, early results show promise for those experiencing cognitive decline. ^{1 4 5 6 7}

Who Is on the Research Team?

Corinne Fischer, MD

Principal Investigator

Unity Health Toronto

Are You a Good Fit for This Trial?

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

Has not completed at least a grade eight education, as necessary for the completion of the assessments

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05563298

NCT05563298 | Neuro RX Gamma for Amnestic Mild ... This study offers a unique opportunity to investigate whether PBM can modulate mitochondrial and neural processes associated with cognitive decline in aMCI.

2. vielight.com vielight.com/blog/mci-brain-photobiomodulation-vielight-neuro-results/?srsltid=AfmBOoqkcimUHrIiTz1j1ANbV8yrgfqBZO7Inv00nlLHOQ-AwWWXPUSD

MCI and Brain Photobiomodulation | Clinical Results with ... The findings suggest that tPBM, delivered via the Vielight Neuro RX Gamma, may improve executive function, brain connectivity, and mitochondrial health while ...

3. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/537216

Infrared Light for Memory Loss in Mild Cognitive ... 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12321612/

Brain photobiomodulation: a potential treatment in Alzheimer's ... This emergent therapy relies on the discovery that several neurological disorders involve changes in gamma oscillations (20–50 Hz) [46]. However ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06618807

NCT06618807 | Infrared Light for Memory Loss in Mild ... 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 ...

6. vielight.com vielight.com/research/?srsltid=AfmBOoqrrEXGhFHLOVFEZ8_gqmPktK4etHwF0TH_R24Gw0UqLwGB7vnz

Photobiomodulation and Neuro Research: Clinical Studies Neuro RX Gamma. Evaluating the Efficacy of the Vielight Neuro RX Gamma in the Treatment of Post COVID-19 Cognitive Impairment. Long COVID can cause long-term ...

7. reaganudall.org reaganudall.org/clinical-trial/pilot-study-evaluating-efficacy-vielight-neuro-rx-gamma-treatment-post-covid-19

A Pilot Study Evaluating the Efficacy of the Vielight Neuro It is a double blindrandomized controlled trial that is expected to involve 36 participants who are confirmedto have Post- COVID cognitive impairment.