The HealthTech Connex Centre for Neurology Studies is actively seeking volunteers for a clinical trial, sponsored by Vielight Inc., that investigates the effects of a photobiomodulation device (Neuro RX Gamma) on cognitive and behavioural symptoms in individuals with moderate to severe Alzheimer’s disease (AD).

AD is the most common type of dementia. It is a chronic, progressive, neurodegenerative disorder characterized by a decline in memory and other cognitive abilities such as thinking and behavior which are significant enough to interfere with daily life. The Alzheimer Society of Canada estimates that as of 2016 there are over 500,000 Canadian’s living with dementia.

Current treatment for AD includes cholinesterase inhibitors (donepezil, galantamine and rivastigmine), and NMDA receptor antagonists (memantine) which delay or slow the worsening of symptoms and treat cognitive symptoms (memory loss, confusion, and problems with thinking and reasoning). Despite ongoing drug studies and modest clinical benefits of currently approved drug treatments, there remains an urgent need for treatments for long term symptomatic improvement of AD with fewer and less severe side effects.

"This study is especially exciting because it offers a gleam of hope for those with moderate and severe AD, and the risk of side effects is minimal.”

– Sonia Brodie, VP Clinical Research at the Centre for Neurology Studies

Photobiomodulation (PBM) therapy, also called low-level laser (or light) therapy (LLLT), is a safe, non-invasive, non-thermal (no significant heat is generated) method of therapy which uses either visible red or near-infrared (NIR) light to stimulate, heal and repair damaged or dying tissue cells.

This study proposes to use the Neuro RX Gamma device to deliver NIR light energy via LEDs to particular brain regions which are dysfunctional in AD patients.

“The majority of clinical trials for Alzheimer’s disease today focus on the earlier stages of the disease, and many of the potential pharmaceutical options include a lot of undesirable side-effects” said Sonia Brodie, VP Clinical Research at the Centre for Neurology Studies. “This study is especially exciting because it offers a gleam of hope for those with moderate and severe AD, and the risk of side effects is minimal.”

Purpose:

The purpose of this study is to determine the effect of Neuro RX Gamma (interventional device) as a form of treatment to assist in the management of cognitive and behavioral related symptoms in those with moderate to severe AD.

Device:  

The Vielight Neuro RX Gamma is a portable, wearable, low-level light therapy delivery device that administers near-infrared light to the brain transcranial and intranasally. The device can be applied by the patient or caregiver in the comfort of their own home and does not require specialized training. It is to be applied for a 20-minute session once daily for 6 days per week, for a total of 24 weeks.

Placebo-Controlled Design:

Participants in this research study, will have an equal (50/50) chance of bein randomized to one of two groups: active Neuro RX Gamma device or sham Neuro RX Gamma device. Randomization means that the participants are put into a group by chance, like flipping a coin. The study is double-blind, which means neither participants nor doctors will know which group a participant is in.

The device may improve participant’s AD signs and symptoms, general quality of life and decrease the risks of long-term AD related complications. However, there are no guaranteed benefits from participation in this study and being treated with the device. Information gained from this study may benefit other individuals with the same medical condition in the future.

Study Doctor: 

The Site Principal Investigator is Dr George Medvedev, MD, FRCPC Neurology. Division of Neurology Head, Fraser Health Authority, and Director of Neurology at the Centre for Neurology Studies.

What the study will include:

• Screening visit: to determine eligibility, the Severe Impairment Battery (SIB) and mini-mental state examination (MMSE) will be done. An MRI of the head may be required if the participant has not had one within the past 2 years.
• Baseline visit: physical assessments, medical history, and study group assignment
• Treatment Phase: home-based 20-minute treatment sessions, 6 times per week, for 24 weeks (6 months)
• Assessments and follow up visits: at weeks 12 and 24

Eligibility:

Interested individuals may qualify as the study participants if they:

•       Have a diagnosis of Alzheimer’s disease (AD)
•       Age 50 or older
•       Receiving Alzheimer’s disease/psychotropic medication, and must be on a stable dosage for 12 weeks prior to enrolling in the trial with no changes anticipated for the duration of the trial

Compensation is available for participants and their caregivers.

Location:                                                                                                                              

All treatment sessions are done in the comfort of your home. The study requires 3-5 in-person visits to the Centre for Neurology Studies, located in City Centre 1 (Address: 13737 96th Avenue, Unit 204 in Surrey, BC).