Evaluation of RGn600 Device for Adults Aged 55 to 85 with Mild to Moderate Alzheimers Disease

What this Trial Is About

Researchers are evaluating the device RGn600 for treating adults aged 55 to 85 with mild-to-moderate Alzheimers disease. This study aims to demonstrate how RGn600, which combines PhotoBioModulation light therapy using lasers and LEDs and Static Magnetic Stimulation, might reduce brain-gut axis inflammation linked to Alzheimers. The trial is randomized and controlled, involving 108 patients in France over a 52-week period. Participants will be randomly assigned to receive either the active RGn600 device or a sham inactive device. Treatments occur on-site during 20-minute sessions, with five sessions per week for the first 8 weeks, three sessions per week from weeks 9 to 16, and two sessions per week from weeks 17 to 26. After this treatment period, participants will continue to be followed for safety and effects up to week 52. Throughout the study, patients will attend four main visits at the start Day 0, week 8, week 26, and week 52. During these visits, researchers will assess cognition and autonomy using neurological and neuropsychological tests, quality of life through questionnaires with caregiver assistance, and safety by monitoring adverse events and conducting blood tests. Additionally, biological samples like blood, fecal, and saliva samples will be collected from participants at the Toulouse site to support further research on Alzheimers markers and inflammation.

Efficacy of RGn600 in Patients With Mild-to-moderate Alzheimer's Disease