Disclaimer:
Some of the research information pertains to ongoing clinical trials. No representation is made regarding Vielight devices or their capabilities beyond published results.
The information provided is for educational purposes only and is not intended to support the safety or effectiveness of Vielight devices.
The Neuro Rx Gamma is the investigational device used in the pivotal clinical trial for Alzheimer’s disease.

Investigating Photobiomodulation for Alzheimer’s Disease

The clinical trial discussed on this page is set to investigate the effects of the Vielight Neuro RX Gamma device on patients with Alzheimer’s disease. More specifically, the trial is designed to find out whether transcranial-intranasal photobiomodulation could improve cognitive functioning and quality of life in patients with moderate to severe Alzheimer’s Disease.

The participants in the study will receive Neuro RX Gamma devices for home-based treatment sessions. The Neuro RX Gamma delivers low-energy near-infrared LED light to the brain, identically to the Neuro Gamma.

This extensive study involves 228 participants in a double-blind, randomized trial and includes a placebo-controlled group. The trial will take place in 8 sites across North America. It is expected to commence in January 2019 and run till January 2021.

ClinicalTrials.gov Link

Neuro RX Gamma – Pivotal Phase Trial

Ongoing

Direct access to information on pilot study on clinicaltrials.gov – [ Study Link (clinicaltrials.gov, U.S. National Institutes of Health) ]

An IRB-approved large study evaluating the feasibility, safety, and efficacy of the Vielight Neuro Gamma for the treatment of moderate-to-severe Alzheimer’s Disease.

Trial Registration
Click here for more information – ( Link )

The objective of this trial is to determine whether the experimental Neuro Gamma device improves cognitive functioning and quality of life and decreases health services use as compared to a sham device in patients with moderate to severe Alzheimer’s Disease (AD).

Principal Investigator
Dr. Corinne E. Fischer, MD
Director of Memory Disorders Clinic, Geriatric Psychiatry, and Geriatric Mental Health Outreach Program, St. Michael’s Hospital
Adjunct Scientist in the Keenan Research Centre of the Li Ka Shing Knowledge Institute of St. Michael’s Hospital 

Regulatory and Funding Sponsor
Vielight Inc.
346A Jarvis Street Toronto, Ontario M4Y 2G6
Lew Lim, Founder and CEO, lewlim@vielight.com

Methodology Centre
Applied Health Research Centre
The Hub, Li Ka Shing Knowledge Institute St. Michael’s Hospital
30 Bond Street Toronto, ON, M5B 1W8
Stephanie De Masi, demasis@smh.ca

This is a randomized, double-blind, multi-centre trial. The trial will include patients with moderate to severe AD who will be randomized in a 1:1 ratio to active treatment with the Neuro Gamma device, or treatment with a sham device.
The following assessments will be performed during clinic visits at baseline, 12 and 24 weeks and during an extended follow up visit at 52 weeks:
• Severe Impairment Battery (SIB)
• Alzheimer’s Disease Cooperative Study Activities of Daily Living for Severe Alzheimer’s Disease (ADCS-ADL-Sev) scale
• Quality of life using European Quality of Life–5 Dimensions (EQ-5D, proxy version) and the Quality of Life in Alzheimer’s Disease (QOL-AD) scale
• Adverse events (AEs) and serious adverse events (SAEs)
• Resource Utilization in Dementia (RUD) instrument
• Neuropsychiatric Inventory Questionnaire (including Caregiver Distress ratings) at weeks 12, 24 and 52

The Applied Health Research Centre (AHRC) is an Academic Research Organization at the Li Ka Shing Knowledge Institute of St. Michael’s Hospital, with expertise in clinical research methodology and operations. The AHRC has experience managing more than 50 multi-site, national and international clinical trials and observational studies, and has grown to be one of the largest AROs in Canada.

The AHRC will work closely with the study Investigator(s) to manage this clinical trial, including site selection and site management, study training, study documentation, and project communications. AHRC will coordinate data management activities and will be responsible for developing electronic case report forms (eCRFs), performing data validation activities, providing data outputs and performing statistical analyses.

The AHRC employs industry-leading web-based secure database technology (REDCap and Medidata RAVE™) which incorporate advanced data validation and reporting tools, and allow for faster access to trial data than traditional paper-based data collection tools. Our electronic databases have built-in web-based study randomization tools, and can link with other data systems (e.g. laboratory information systems) to facilitate automatic upload of clinical data to minimize manual entry. The AHRC is using electronic data capture software to manage data for over 30 studies, including more than 20 CIHR-funded multi-centre trials.

History of research

2018-2019

Photobiomodulation for Improving Brain Function in Dementia

[ Published Study Link (Photobiomodulation, Photomedicine, and Laser Surgery)

    ( 8 participants | 1 year | Published )
Pulsed Near Infrared Transcranial and Intranasal Photobiomodulation Significantly Modulates Neural Oscillations

[ Published Study Link (Nature, Scientific Reports)]

    ( 20 participants | 1 year | Published )

2014 – 2016

Significant Improvement in Cognition in Mild to Moderately Severe Dementia Cases Treated with Transcranial Plus Intranasal Photobiomodulation: Case Series Report

Co-authoring institutes – Harvard Medical School, Boston University School of Medicine

[ Full Publication (US National Library of Medicine) | Download Transcript ]

Brain Photobiomodulation

Brain Photobiomodulation has enormous research potential

Gamma Neural Oscillations

Published in Nature, Scientific Reports – April 2019

Dr Corinne Fischer
Dr Corinne FischerChief Principal Investigator
Dr Corinne Fischer’s research focus includes the study of neuropsychiatric symptoms in dementia, specifically delusions and their neurocognitive/neurobiological correlates.

Dr. Fischer is an adjunct scientist and co-director of Neurodegenerative Research, Division of Neuroscience Research, at the Keenan Research Centre for Biomedical Research, the Li Ka Shing Knowledge Institute, St. Michael’s Hospital.

St Michael’s Hospital

The principal testing site will take place at St. Michael’s Hospital in Toronto, Ontario.

Home to the Li Ka Shing Knowledge Institute, made up of the Keenan Research Centre and the Li Ka Shing International Healthcare Education Centre, the hospital is among the first in the world to bring together researchers, educators and clinicians to take best practices and research discoveries to patient bedsides faster.

Disclaimer: Some of the research information pertains to ongoing clinical trials. No representation is made regarding Vielight devices or their capabilities beyond published results.
Please note that the Neuro Gamma device is not the same as the Neuro RX Gamma that is currently being used in our clinical trials.
The RX Gamma is intended to be fully compliant with regulatory requirements for a medical device and will not be available without regulatory clearance. The “Neuro RX Gamma” is therefore a different product from the “Neuro Gamma”.

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