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)
REGEnLIFE SAS
108 participants
Jul 24, 2023
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
Plain Language Summary
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Interventions
RGn600 with a 10 Hz-pulsed wave mode light emission
RGn600 inactivated
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT05926011