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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: REGEnLIFE SAS • ClinicalTrials.gov ID: NCT05926011

Registry updated: 2026-08-21
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Description

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.

Interventions

  • RGn600 (Device)
    RGn600 with a 10 Hz-pulsed wave mode light emission
  • RGn600 Sham (Device)
    RGn600 inactivated

Eligibility criteria

Inclusion Criteria: * Male or female aged 55 to 85 years old (both included) * Diagnosed with AD according to McKhann et al. international criteria dated 2011 * With mild-to-moderate AD, i.e., 10 ≤ MMSE score ≤ 26 * With blood analyses results (for: thyroid-stimulating hormone, vitamin B12, folate, complete blood count including platelets, electrolytes including calcium, creatinine, clearance, alanine aminotransferase, aspartate aminotransferase, bilirubin, coagulation, C-reactive protein) dated less than 1 year ago in line with AD diagnosis, as deemed by the investigator * With brain Computed Tomography (CT) or/and Magnetic Resonance Imaging (MRI) scan dated less than 1 year ago in line with AD diagnosis, as deemed by the investigator * In case of treatment with AD symptomatic treatments (memantine and acetylcholinesterase inhibitors) and psychotropic treatments (anxiolytics, antidepressants and neuroleptics): with a stable dose of such treatments 4 weeks before inclusion * Who has a caregiver who is sufficiently and regularly present and can help the patient throughout the investigation, as deemed by the investigator * Affiliated to French social security * Who provided, with his/her caregiver, a dated and signed informed consent form. Exclusion Criteria: * Patient protected by a French legal measure ("sauvegarde de justice", "tutelle" or "curatelle") * Patient deprived of liberty or hospitalized without consent * Non-menopausal woman * Patient taking a disease-modifying treatment such as the Leqembi® or any other disease-modifying treatment that may be authorized in France before the end of the study * Patient living in a medical facility * Patient who experienced a surgery at the treatment application area (abdomen or head) within 3 months prior inclusion * Patient with skin lesions on the treatment application area (abdomen or head) * Patient with a short-term life-threatening pathology (e.g., evolving cancer; non-stable heart failure; severe hepatic, renal or respiratory failure, etc.) * Patient diagnosed with a stroke within 3 months prior inclusion * Patients with ferromagnetic material (i.e., iron, nickel, cobalt or any metal alloy) on or near the head or abdomen, or implanted with a pacemaker * Patient with a risk of epileptic seizure * Patient with a genetic form of AD * Patient with major physical or neurosensorial disorders that may interfere with neurological assessments * Patient with chronic psychosis or psychotic episodes * Patient addicted to alcohol or drugs * Patient with known and non-supplemented vitamin B12 and folic acid deficiencies * Patient with known untreated hypothyroidism * Patient who participated to another investigation/study involving the use of an investigational medical device/drug within the 30 days prior inclusion * Patient not able to meet treatment sessions as deemed by the investigator * Patient not able to complete requested investigation assessments as deemed by the investigator.

Conditions

Alzheimer Disease

Locations

  • CHIC Castres Mazamet Site Autan — Castres, France
  • CH Lavaur — Lavaur, France
  • Hôpital Lariboisière — Paris, France
  • Hôpital Broca — Paris, France
  • Biofortis — Saint-Herblain, France
  • Toulouse University Hospital Gerontopole — Toulouse, France
  • Hôpital des Charpennes - HCL — Villeurbanne, France
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record