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Efficacy of RGn600 in Patients With Mild-to-moderate Alzheimer's Disease
Sponsor: REGEnLIFE SAS
Summary
This is a controlled investigation, with randomization of the patients, which aims at demonstrating the efficacy of device RGn600 in treating patients with mild-to-moderate Alzheimer's disease (AD). RGn600 is a non-invasive medical device which is applied on the head (helmet) and on the abdomen (abdominal belt). It combines 2 technologies: * PhotoBioModulation (PBM), which involves exposure to light from the red to near-infrared wavelengths using lasers and Light Emitting Diodes (LEDs) * Static Magnetic Stimulation (SMS), which consists in the application of a static magnetic field. Considering previous investigations, this innovative technology could reduce inflammation on the brain-gut axis, implicated in the development of Alzheimer's disease.
Official title: Efficacy of RGn600 in Patients With Mild-to-moderate Alzheimer's Disease: a Pivotal, Sham-controlled, Randomized, Double-blind, Multicentric Investigation (LIGHT4LIFE)
Key Details
Gender
All
Age Range
55 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
108
Start Date
2023-07-24
Completion Date
2026-12
Last Updated
2025-04-06
Healthy Volunteers
No
Conditions
Interventions
RGn600
RGn600 with a 10 Hz-pulsed wave mode light emission
RGn600 Sham
RGn600 inactivated
Locations (6)
CHIC Castres Mazamet Site Autan
Castres, France
CH Lavaur
Lavaur, France
Hôpital Lariboisière
Paris, France
Hôpital Broca
Paris, France
Hôpital de la Timone,
Timone, France
Toulouse University Hospital Gerontopole
Toulouse, France