Neuro RX Gamma for Mild Cognitive Impairment
Recruiting in Palo Alto (17 mi)
Overseen byCorinne Fischer, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
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
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.
12345Eligibility 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
+2 more
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.
+15 more
Trial 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)
Participant Groups
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.
2Treatment groups
Active Control
Placebo Group
Group I: Active Neuro Rx DeviceActive Control1 Intervention
The active device will deliver light for the 20 minutes session duration.
Group II: Sham Neuro Rx DevicePlacebo Group1 Intervention
The Sham device is indistinguishable from the active device. The sham device will not deliver light for the 20 minutes session duration.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
St Michael's HospitalToronto, Canada
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Who Is Running the Clinical Trial?
Unity Health TorontoLead Sponsor
References
Safety and efficacy of galantamine in subjects with mild cognitive impairment. [2022]To assess the safety of galantamine in subjects with mild cognitive impairment (MCI), the ability of galantamine to benefit cognition and global functioning in subjects with MCI, and the ability of galantamine to delay conversion to dementia.
Effects of electroacupuncture combined with computer-based cognitive rehabilitation on mild cognitive impairment: study protocol for a pilot randomized controlled trial. [2020]Mild cognitive impairment (MCI) is defined as an intermediate stage between normal aging and Alzheimer's disease (AD), and early and easily available interventions to delay the progress of MCI to AD are necessary. Feasible complementary and alternative therapies such as electroacupuncture (EA), exercise, and cognitive training have shown some beneficial effects on MCI and AD. Here we report the protocol for a randomized controlled trial of the efficacy and safety of EA combined with computer-based cognitive rehabilitation (EA-CCR) for the treatment of MCI.
The Efficacy of Cocoa Polyphenols in the Treatment of Mild Cognitive Impairment: A Retrospective Study. [2023]Background: Mild cognitive impairment (MCI) is characterized by cognition impairment that does not interfere with the usual activities of daily living. It is considered to be a transitional stage between normal aging and dementia. No treatment is available for MCI. Methods: This retrospective cohort study included 55 patients (29 males and 26 females, aged 56-75 years) with a diagnosis of amnestic MCI who attended the Center for Cognitive Disorder and Dementia of the IRCCS Centro Neurolesi Bonino Pulejo (Messina, Italy) between January and December of 2017. As we aimed to evaluate the effect of cocoa polyphenols on cognition, the study population was separated into two groups depending on the change in their Mini-Mental State Examination (MMSE) score at a one-year follow-up. Results: Compared to G2 (i.e., patients with a worsening in cognitive functions), the rate of polyphenol intake was significantly higher in patients without a worsening in cognition (i.e., G1) (χ2 = 13.79, df = 1, p-value < 0.001). By subdividing G1 patients based on whether they improved or were stable at follow-up, we found that 46.2% of those who had improved were treated with polyphenols. Conclusions: Dietary supplementation of cocoa flavonoids seems to reduce the progression of MCI to dementia. Further prospective studies with larger sample volumes are required to confirm these promising findings.
Efficacy and Safety of MLC601 in the Treatment of Mild Cognitive Impairment: A Pilot, Randomized, Double-Blind, Placebo-Controlled Study. [2022]Mild cognitive impairment (MCI) is characterized by declined cognitive function greater than that expected for a person's age. The clinical significance of this condition is its possible progression to dementia. MLC601 is a natural neuroprotective medication that has shown promising effects in Alzheimer disease. Accordingly, we conducted this randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of MLC601 in MCI patients.
[The use of cereton in patients with chronic brain ischemia and moderate cognitive impairment]. [2017]To study the efficacy and safety of cereton in the treatment of patients with chronic brain ischemia and moderate cognitive impairment.