Clinical trial of light therapy to reduce symptoms of Alzheimer's

The first large clinical trial is underway to determine if shining a specific kind of light through the skull can reverse the course of Alzheimer's, including reduction of symptoms even in moderate and severe cases. Current Alzheimer's medications and new drugs being researched are only aimed at slowing the progression of the disease. The double-blind, randomized trial (including a placebo control group) began in January 2019 and is ongoing. A completion date is not yet set, due to recruitment issues during the pandemic. (ClinicalTrials.gov and Vielight.com/research).

Vielight offers an 80% refund policy, valid within six months from the time of purchase.

Previous small studies with dementia patients using light therapy "have seen people regain their memory, reading and writing skills, and orientation."

In a January 2020 article in UK news outlet The Telegraph, the CEO of Vielight, Dr. Lew Lim, states that:

"We have a much bigger ambition than the drug trials. Drug developers are mainly either seeking to slow the mental decline in diagnosed cases, or seeking to prevent the onset of Alzheimer's disease by intervening at the pre-symptomatic stage.

"Based on early data, we are confident of seeing some measure of recovery in the symptoms, not just a slowdown in the rate of decline, even in moderate to severe cases." 

Vielight, a Canadian science and engineering company, has developed the portable headsets that are used in this clinical trial; the headsets deliver light therapy to the brain using LED lights that emit near-infrared light at a pulsed output.

Research is discovering several mechanisms of action - explanations for why light therapy, also called photobiomodulation, has a positive effect on the brain. One of the theories is that "light boosts the mitochondria - the cell's batteries - which produce fuel for the cells and improves their function and communication." Because of this energy boost, the brain's microglial (immune) cells are stimulated to clear away amyloid plaques, which are associated with Alzheimer's disease. 

This theory rests in part on the 2017 MIT research, which studied mice that were bred to develop Alzheimer's and that had cognitive loss and could not find their way through mazes. When these mice were exposed to light pulsed at 40 hertz, the mice were able to find their way through mazes once again. When the mice brains were dissected, the researchers found that amyloid plaques, the hallmark of Alzheimer's disease, were significantly reduced.

An earlier 2018 pilot clinical trial using the Vielight Neuro Gamma with patients who had dementia found the following results: light therapy improved cognitive and behavioral test results, increased cerebral blood flow, and stimulated greater connectivity in the brain, as seen in functional MRI scans. According to The Telegraph, these study participants, who had "mild to moderately severe dementia, all showed significant improvement after 12 weeks, with increased function, better sleep, fewer angry outbursts, less anxiety, and wandering." The improvements slipped away, and the study participants declined after the study ended when they no longer had access to light therapy.

Read more about this 2018 study on our Alzheimer's research page; the poster presentation of the study is here. It's important to note that some case studies with light therapy demonstrated that study participants who bought their own Vielight devices and continued light therapy at home retained their improvements. 

The current clinical trial, described in The Telegraph article, involves 228 study participants in a double-blind, randomized trial. Half of the study participants will use the Vielight Neuro RX Gamma device at home, with a schedule of one twenty-minute session six days a week, for 24 weeks. The wearable headset shines light through the skull, delivering near-infrared light pulsed at 40 hertz. The headset has an attached nasal clip that shines light through one nostril to "the hippocampus, the part of the brain which is responsible for memory, and one of the first areas to deteriorate in Alzheimer's disease." More about this current clinical trial is on our Alzheimer's research page.

The trial is led by researchers at the University of Toronto, with study participants in eight locations throughout Canada and the United States. Because the study is a double-blind, randomized trial, a control group of participants will use a sham (fake) device on the same schedule. Researchers will not know whether a study participant is using a real device or a fake device until the results are calculated.

Vielight offers an 80% refund policy, valid within six months from the time of purchase.

Neuro RX Gamma vs. Neuro Gamma devices

The Neuro RX Gamma is a new device manufactured to meet medical device standards, compared to the Vielight Neuro Gamma 3, which is available for purchase on the Vielight website and classified as a wellness device. The light output of both devices is the same: 810 nm near-infrared light energy, pulsed at 40 Hz.

Vielight has changed the design of the Neuro 3 series; the controller is now small and is attached to the headset. The light output in this new (2022) series has not changed. The company also has a Neuro Duo 3 device, which has a switch on the controller allowing the user to switch between 10 Hz light output (the same as the Neuro Alpha 3) and 40 Hz (the same as the Neuro Gamma 3).

While the current large trial uses the Vielight Neuro RX Gamma, the 2018 pilot study had participants use the Vielight Neuro Gamma device for one twenty-minute session every other day for 12 weeks. 

According to the article in The Telegraph, we can expect to see the results of the current clinical trial in three years. In the meantime, there are anecdotal accounts such as the one in the article: Liz Burnett, whose 88-year-old father Rudy began using the device eight years ago, had seen a dramatic improvement. 

"It seemed to slow the progression of Alzheimer's," she said. "He also remembered more. His immune system improved as he didn't get the flu anymore.

"All his siblings passed away around 83. He is still around at 88. He is the longest living family member so far.

"I use the device myself, and I sleep better, feel better."

Footnotes: Mechanism of action for the therapeutic action of photobiomodulation

Pulsed Near-Infrared Transcranial and Intranasal Photobiomodulation Significantly Modulates Neural Oscillations: a pilot exploratory study. 2019

“The effect of [photobiomodulation] PBM on mitochondrial function is the most well-investigated mechanism of its potential therapeutic effects4. PBM has been demonstrated to increase the activity of complexes in the electron transport chain of mitochondria, including complexes I, II, III, IV and succinate dehydrogenase16. In particular, increased activity of the transmembrane protein complex IV, also known as the enzyme cytochrome c oxidase, during PBM results in increased ATP production16. Furthermore, PBM results in activation of signaling pathways and transcription factors resulting in increased expression of genes related to protein synthesis, cell migration and proliferation, anti-inflammatory signaling, anti-apoptotic protein and antioxidant enzymes See this article: 4.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6474892/