MedTrace Logo

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

NCT05926011 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-04-06

No results posted yet for this study

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.

Conditions

  • Alzheimer Disease

Interventions

DEVICE

RGn600

RGn600 with a 10 Hz-pulsed wave mode light emission

DEVICE

RGn600 Sham

RGn600 inactivated

Sponsors & Collaborators

  • RCTs

    collaborator INDUSTRY

  • University Hospital, Toulouse

    collaborator OTHER

  • REGEnLIFE SAS

    lead INDUSTRY

Principal Investigators

  • Guillaume BLIVET · REGEnLIFE SAS

  • Jacques TOUCHON · Montpellier University

  • Julien DELRIEU · Toulouse University Hospital Gerontopole

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-24
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05926011 on ClinicalTrials.gov