Lavaur

Researchers are evaluating the efficacy of the RGn600 device in treating patients with mild-to-moderate Alzheimer's disease. This randomized, sham-controlled, double-blind study involves 108 patients in France and aims to assess the impact of RGn600, a non-invasive device combining PhotoBioModulation (PBM) and Static Magnetic Stimulation (SMS), on brain-gut axis inflammation related to Alzheimer's disease. The study follows patients up to 52 weeks to understand the treatment's effects on cognition and other outcomes. Participants are randomly assigned to receive either the active RGn600 device or a sham device. The device is applied on the head and abdomen for 20-minute onsite sessions over 26 weeks with a decreasing frequency: five sessions per week during weeks 1 to 8, three sessions per week during weeks 9 to 16, and two sessions per week during weeks 17 to 26. After treatment, patients continue to be followed for an additional period up to week 52. During the study, patients undergo assessments at four onsite visits at Day 0, Week 8, Week 26, and Week 52. Evaluations include cognitive tests, neurological scales, quality of life questionnaires, and safety monitoring including adverse event reporting and blood tests. A biobank will collect blood, fecal, and saliva samples from patients at the Toulouse University Hospital site to support further biological analyses related to Alzheimer’s disease markers and inflammation.