Mélanie Wachtel, France
ICTA PM MedicalAuthor Of 1 Presentation
BRAIN-GUT PHOTOBIOMODULATION FOR ALZHEIMER’S DISEASE: SAFETY AND EFFICACY OF THE REGENLIFE RGN530 DEVICE, A RANDOMIZED, DOUBLE-BLIND AND CONTROLLED TRIAL
Abstract
Aims
Evaluation of the safety and efficacy of the RGn530 photobiomodulation device on cognitive performances in mild-to-moderate AD patients.
Methods
This double-blind, randomized, monocenter, placebo-controlled clinical trial started in 2018, prematurely ended in 2020 due to Covid-19 pandemic. Only 53 patients were randomized into 2 groups: 27 patients treated and 26 patients not treated (placebo-sham group). Each patient received five 25-min sessions per week for 8 weeks and total study duration was 12 weeks. The primary efficacy endpoint was the evolution of the ADAS-Cog total score between inclusion and W8.
Results
RGn530 device appeared safe, as only 4.0% of patients reported possibly medical device-related adverse events (AEs) without significant difference in both groups and no serious AEs have been reported. The compliance with treatment sessions was very good for 92% of patients, confirming the good tolerance of the device. The primary efficacy endpoint was not met but a significant decrease in the ADAS-Cog comprehension subscore in the treated group compared to placebo was observed (mean change at W8 was -0.4±0.9 and 0.3±0.9, respectively; p=0.029). First efficacy results suggested a role in executive functions, as showed by TMT-B completion time significantly lower in patients treated compared to placebo (mean change at W8 was -45.8±88.0 sec and 53.1±83.8 sec, respectively; p=0.012), indicating better performances.
Conclusions
The results of this pilot study showed that the REGEnLIFE device is safe and well tolerated by patients. These very encouraging safety and efficacy results need to be confirmed in a pivotal phase III clinical trial.