Vielight begins clinical trial for Alzheimer’s disease

KUALA LUMPUR, June 7 (Bernama) -- Vielight Inc, a leader in brain photobiomodulation (PBM) technology, announced the primary site for its pivotal clinical trial, St. Michael’s Hospital in Toronto, has been activated.

The hospital is the first among the eight sites that will carry out the study.

Conducted across North America, the trial will be a randomised, placebo-controlled study involving 228 subjects with moderate to severe cognitive impairment due to Alzheimer’s disease.

The protocol of the study has been reviewed by the US Food and Drug Administration and Health Canada.

The device in investigation, called the ‘Vielight Neuro RX Gamma’, is based on Vielight’s proprietary PBM technology which directs near infrared light, pulsing at the gamma rate of 40 Hz, to selected regions of the brain.

The procedure is non-invasive and the device has been designed to be suitable for home-use.

Subject to regulatory clearance, the device will be indicated for Alzheimer patients with moderate to severe impairment, the group that demands the most care and has the largest economic burden.

The trial will be independently managed by the Applied Health Research Centre, a methodology centre affiliated with St Michael’s Hospital.

-- BERNAMA