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

Alzheimer Disease

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

Inclusion Criteria9

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 Criteria20

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.