Jacques Touchon, MD, PhD, University Hospital of Montpellier, Montpellier, France, shares the findings from a double-blind, randomized, monocenter, placebo-controlled clinical trial (NCT03672474) evaluating the safety and efficacy of the RGn530 photobiomodulation device on cognitive performances in mild-to-moderate Alzheimer’s disease patients. Due to the COVID-19 pandemic, the study ended prematurely, and only 53 patients were enrolled. The RGn530 device showed a good safety profile, no serious adverse events were reported, and the compliance with treatment was very good for most patients. The primary efficacy endpoint, ADAS-Cog score, was not met, but a significant decrease was observed in the treated group compared to placebo. Additionally, efficacy results suggested a role in executive functions, as demonstrated by TMT-B completion time, significantly lower in patients treated compared to placebo. These encouraging findings will be confirmed in a pivotal Phase III clinical trial. This interview took place during the AD/PD™ 2021 conference.
