[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510405":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":42,"locations":48,"responsibleParty":141,"collaborators":143,"id":149,"slug":150,"hasResults":151,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":151,"sex":157,"minAge":158,"maxAge":159,"enrollmentInfo":160,"targetDuration":25,"studyType":163,"phases":164,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":51,"whyStopped":25,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":187},{"fullName":5,"class":6},"REGEnLIFE SAS","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active RGn600","EXPERIMENTAL","RGn600 with a 10 Hz-pulsed wave mode light emission",[13],"Device: RGn600",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham","SHAM_COMPARATOR","Inactivated RGn600",[19],"Device: RGn600 Sham",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DEVICE","RGn600",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"RGn600 Sham","RGn600 inactivated",[15],[31,34,38],{"name":32,"affiliation":5,"role":33},"Guillaume BLIVET","STUDY_DIRECTOR",{"name":35,"affiliation":36,"role":37},"Jacques TOUCHON","Montpellier University","STUDY_CHAIR",{"name":39,"affiliation":40,"role":41},"Julien DELRIEU","Toulouse University Hospital Gerontopole","PRINCIPAL_INVESTIGATOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":25,"email":47},"Guillaume CHAMPLEBOUX","CONTACT","+33 649 813 454","gchampleboux@regenlife.com",[49,66,79,92,102,115,128],{"facility":50,"status":51,"city":52,"state":25,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"CHIC Castres Mazamet Site Autan","RECRUITING","Castres","81100","France","FR",{"type":57,"coordinates":58},"Point",[59,60],2.24088,43.60527,{"lat":60,"lon":59},[63],{"name":64,"role":45,"phone":25,"phoneExt":25,"email":65},"Marie-Noëlle Cufi, Geriatrician","marie-noelle.cufi@chic-cm.fr",{"facility":67,"status":51,"city":68,"state":25,"zip":69,"country":54,"countryCode":55,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"CH Lavaur","Lavaur","81500",{"type":57,"coordinates":71},[72,73],1.81211,43.69886,{"lat":73,"lon":72},[76],{"name":77,"role":45,"phone":25,"phoneExt":25,"email":78},"Louise Naccache, Geriatrician","l.naccache@ch-lavaur.fr",{"facility":80,"status":51,"city":81,"state":25,"zip":82,"country":54,"countryCode":55,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Hôpital Lariboisière","Paris","75010",{"type":57,"coordinates":84},[85,86],2.3488,48.85341,{"lat":86,"lon":85},[89],{"name":90,"role":45,"phone":25,"phoneExt":25,"email":91},"Claire PAQUET, Neurologist","claire.paquet@aphp.fr",{"facility":93,"status":51,"city":81,"state":25,"zip":94,"country":54,"countryCode":55,"cosmosGeoPoint":95,"geoPoint":97,"contacts":98},"Hôpital Broca","75013",{"type":57,"coordinates":96},[85,86],{"lat":86,"lon":85},[99],{"name":100,"role":45,"phone":25,"phoneExt":25,"email":101},"Marie Laure SEUX, Geriatrician","marie-laure.seux@aphp.fr",{"facility":103,"status":51,"city":104,"state":25,"zip":105,"country":54,"countryCode":55,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Biofortis","Saint-Herblain","44800",{"type":57,"coordinates":107},[108,109],-1.651,47.21154,{"lat":109,"lon":108},[112],{"name":113,"role":45,"phone":25,"phoneExt":25,"email":114},"Maud JOURDAIN, General practitioner","maud.jourdain@biofortis.fr",{"facility":40,"status":51,"city":116,"state":25,"zip":117,"country":54,"countryCode":55,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Toulouse","31 000",{"type":57,"coordinates":119},[120,121],1.44367,43.60426,{"lat":121,"lon":120},[124],{"name":125,"role":45,"phone":126,"phoneExt":25,"email":127},"Julien DELRIEU, Neurologist-Geriatrician","+33 5 61 77 70 58","delrieu.j@chu-toulouse.fr",{"facility":129,"status":51,"city":130,"state":25,"zip":131,"country":54,"countryCode":55,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Hôpital des Charpennes - HCL","Villeurbanne","69100",{"type":57,"coordinates":133},[134,135],4.8795,45.76601,{"lat":135,"lon":134},[138],{"name":139,"role":45,"phone":25,"phoneExt":25,"email":140},"Antoine GARNIER-CRUSSARD, Geriatrician","antoine.garnier-crussard@chu-lyon.fr",{"type":142,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[144,146],{"name":145,"class":6},"RCTs",{"name":147,"class":148},"University Hospital, Toulouse","OTHER","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":161,"type":162},108,"ESTIMATED","INTERVENTIONAL",[165],"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.",[168],"Alzheimer Disease",[170,171,172,173,174,175,176,177],"Alzheimer","Neurostimulation","Optics and photonics","Photobiomodulation","Brain Diseases","Central Nervous System Diseases","Nervous System Diseases","Medical Device","2026-08-19",{"date":180,"type":181},"2026-08-21","ACTUAL",{"date":183,"type":181},"2023-07-24",{"date":185,"type":162},"2027-12",{"name":5,"class":6},7]