Neuro RX Gamma for Amnestic Mild Cognitive Impairment (aMCI)

MCI Clinical Trial

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)

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

The experimental intervention will be the Vielight Neuro RX Gamma photobiomodulation device. The device uses 5 light emitting diodes (810nm wavelength). Diodes are placed on the skull at equidistance as well as intranasally to target relevant brain areas. No significant heat is generated, allowing for a sham device which will be indistinguishable from the intervention to the subjects. All subjects will be treated in 20 min sessions once daily for 6 days/week for 6 weeks. Subjects/caregivers will be taught to use the device at home and maintain a treatment diary. 20 min sessions of treatment (or sham) administered 6 days/week for 6 weeks by the subject.

Baseline (T0) and 6-week (T2): 2 visits per subject pre and post treatment (at baseline, 6-week) for the following assessments:

Mini-Mental State Examination (MMSE), CVLT Long delayed free recall, TMT B, TMT A, BVMT-R, Stroop neuropsychological screening, Pittsburgh sleep quality index, Beck's depression inventory, QOL-AD (Quality of life) , Mild Behavioral Impairment Checklist (MBI-C), Lactate, lactate/pyruvate blood test, Structural and functional MRI , One visits at week 3 (remote or in person) for safety assessment.

Safety Endpoints:

SAEs regardless of device causality, Device-related AEs, Rates of epistaxis and nasal infection. ;

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Dysfunction
• MCI

• NCT number: NCT05563298
• Study type: Interventional
• Source: Unity Health Toronto
• Contact: Corinne Fischer, MD
• Phone: 416-864-5320
• Email: Corinne.Fischer@unityhealth.to
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2023
• Completion date: March 30, 2025