Tests a light and magnetic device in people with early Alzheimer's disease
Tests the RGn600 light and magnetic device in people with early Alzheimer's.
Plain-language title generated from the registry record
Registry title: Efficacy of RGn600 in Patients With Mild-to-moderate Alzheimer's Disease
Key facts
- Where
- Castres, Lavaur, Paris, Saint-Herblain, Toulouse, and Villeurbanne, FranceSee the 7 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 55 and 85 years old?
Source: NCT05926011, who can take part
Where in France
- CHIC Castres Mazamet Site AutanCastres, FranceTaking people
- CH LavaurLavaur, FranceTaking people
- Hôpital BrocaParis, FranceTaking people
- Hôpital LariboisièreParis, FranceTaking people
- BiofortisSaint-Herblain, FranceTaking people
- Toulouse University Hospital GerontopoleToulouse, FranceTaking people
- Hôpital des Charpennes - HCLVilleurbanne, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- REGEnLIFE SAS
- Trial code
- NCT05926011
- Record updated
- 21 August 2026
- Original 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:Read full original descriptionShow less
Efficacy of RGn600 in Patients With Mild-to-moderate Alzheimer's Disease: a Pivotal, Sham-controlled, Randomized, Double-blind, Multicentric Investigation (LIGHT4LIFE)
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.
Inclusion: 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: Patient who experienced a surgery at the treatment application area (abdomen or head) within 3 months prior inclusion; Patient diagnosed with a stroke within 3 months prior inclusion; Patient addicted to alcohol or drugs; Patient who participated to another investigation/study involving the use of an investigational medical device/drug within the 30 days prior inclusion; 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 with a short-term life-threatening pathology (e.g., evolving cancer; non-stable heart failure; severe hepatic, renal or respiratory failure, etc.); Patient with a risk of epileptic seizure; Patient with major physical or neurosensorial disorders that may interfere with neurological assessments; 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 living in a medical facility; Patient with skin lesions on the treatment application area (abdomen or head); 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 genetic form of AD; Patient with chronic psychosis or psychotic episodes; Patient with known and non-supplemented vitamin B12 and folic acid deficiencies; Patient with known untreated hypothyroidism; 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.