[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"REGEnLIFE SAS\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":51},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100510405","efficacy-of-rgn600-in-patients-with-mild-to-moderate-alzheimers-disease-100510405",false,"NCT05926011","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)","LIGHT4LIFE","Inclusion Criteria:\n\n* Male or female aged 55 to 85 years old (both included)\n* Diagnosed with AD according to McKhann et al. international criteria dated 2011\n* With mild-to-moderate AD, i.e., 10 ≤ MMSE score ≤ 26\n* 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\n* With brain Computed Tomography (CT) or\u002Fand Magnetic Resonance Imaging (MRI) scan dated less than 1 year ago in line with AD diagnosis, as deemed by the investigator\n* 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\n* Who has a caregiver who is sufficiently and regularly present and can help the patient throughout the investigation, as deemed by the investigator\n* Affiliated to French social security\n* Who provided, with his\u002Fher caregiver, a dated and signed informed consent form.\n\nExclusion Criteria:\n\n* Patient protected by a French legal measure (\"sauvegarde de justice\", \"tutelle\" or \"curatelle\")\n* Patient deprived of liberty or hospitalized without consent\n* Non-menopausal woman\n* 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\n* Patient living in a medical facility\n* Patient who experienced a surgery at the treatment application area (abdomen or head) within 3 months prior inclusion\n* Patient with skin lesions on the treatment application area (abdomen or head)\n* Patient with a short-term life-threatening pathology (e.g., evolving cancer; non-stable heart failure; severe hepatic, renal or respiratory failure, etc.)\n* Patient diagnosed with a stroke within 3 months prior inclusion\n* 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\n* Patient with a risk of epileptic seizure\n* Patient with a genetic form of AD\n* Patient with major physical or neurosensorial disorders that may interfere with neurological assessments\n* Patient with chronic psychosis or psychotic episodes\n* Patient addicted to alcohol or drugs\n* Patient with known and non-supplemented vitamin B12 and folic acid deficiencies\n* Patient with known untreated hypothyroidism\n* Patient who participated to another investigation\u002Fstudy involving the use of an investigational medical device\u002Fdrug within the 30 days prior inclusion\n* Patient not able to meet treatment sessions as deemed by the investigator\n* Patient not able to complete requested investigation assessments as deemed by the investigator.","ALL","55 Years","85 Years",{"count":21,"type":22},108,"ESTIMATED","INTERVENTIONAL",[25],"NA","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:\n\n* PhotoBioModulation (PBM), which involves exposure to light from the red to near-infrared wavelengths using lasers and Light Emitting Diodes (LEDs)\n* Static Magnetic Stimulation (SMS), which consists in the application of a static magnetic field.\n\nConsidering previous investigations, this innovative technology could reduce inflammation on the brain-gut axis, implicated in the development of Alzheimer's disease.",[28],"Alzheimer Disease",[30,31,32,33,34,35,36,37],"Alzheimer","Neurostimulation","Optics and photonics","Photobiomodulation","Brain Diseases","Central Nervous System Diseases","Nervous System Diseases","Medical Device","RECRUITING","2026-08-19",{"date":41,"type":42},"2026-08-21","ACTUAL",{"date":44,"type":42},"2023-07-24",{"date":46,"type":22},"2027-12",{"name":48,"class":49},"REGEnLIFE SAS","INDUSTRY",7,""]