Ireland
--:--IST
Recruiting Not applicable

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

NCT05926011 · tracked via the Priya Life Science France tracker
Sponsor
REGEnLIFE SAS
Phase
Not applicable
Started
2023-07-24
Last updated
2026-08-21

Condition(s) studied

Alzheimer Disease

Investigational drug(s) / intervention(s)

RGn600RGn600 Sham

RGn600: RGn600 with a 10 Hz-pulsed wave mode light emission

RGn600 Sham: RGn600 inactivated

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.

Eligibility

Sex
ALL
Min age
55 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Evolution of patient's cognition between Day 0 and Week 26 as measured with the AD Assessment Scale-cognitive subscale (ADAS-cog) score — Day 0, Week 26
    Absolute change (Week 26-Day 0) in ADAS-cog score

Trial sites (7)

FacilityCityRegionStatus
CHIC Castres Mazamet Site Autan Castres France Recruiting
CH Lavaur Lavaur France Recruiting
Hôpital Lariboisière Paris France Recruiting
Hôpital Broca Paris France Recruiting
Biofortis Saint-Herblain France Recruiting
Toulouse University Hospital Gerontopole Toulouse France Recruiting
Hôpital des Charpennes - HCL Villeurbanne France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05926011 on ClinicalTrials.gov ↗ ← All trials in France