RecruitingNot ApplicableNCT05926011

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

Efficacy of RGn600 in Patients With Mild-to-moderate Alzheimer's Disease: a Pivotal, Sham-controlled, Randomized, Double-blind, Multicentric Investigation (LIGHT4LIFE)


Sponsor

REGEnLIFE SAS

Enrollment

108 participants

Start Date

Jul 24, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 55 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a device called RGn600 — worn on the body — can help improve symptoms in people with mild-to-moderate Alzheimer's disease in France. **You may be eligible if...** - You are between 55 and 85 years old - You have been diagnosed with Alzheimer's disease (mild to moderate stage, with a memory test score between 10 and 26) - You have had recent blood tests and a brain scan (CT or MRI) within the past year - You have a caregiver who can assist you throughout the study - You are enrolled in the French national health insurance system - If you take Alzheimer's or psychiatric medications, your dose has been stable for at least 4 weeks **You may NOT be eligible if...** - You are a woman who has not gone through menopause - You currently take a disease-modifying Alzheimer's drug (such as Leqembi) - You live in a medical facility - You have had surgery near your head or abdomen in the last 3 months - You have a pacemaker or metal implants near your head or abdomen - You have epilepsy, psychosis, or a genetic form of Alzheimer's - You have a life-threatening illness or recent stroke Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICERGn600

RGn600 with a 10 Hz-pulsed wave mode light emission

DEVICERGn600 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05926011


Related Trials