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RECRUITING
NCT05926011
NA

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

Sponsor: REGEnLIFE SAS

View on ClinicalTrials.gov

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

Interventions

DEVICE

RGn600

RGn600 with a 10 Hz-pulsed wave mode light emission

DEVICE

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