Efficacy of RGn600 in Patients With Mild-to-moderate Alzheimer's Disease (LIGHT4LIFE)
Alzheimer Disease
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer, Neurostimulation, Optics and photonics, Photobiomodulation, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Medical Device
Eligibility Criteria
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 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 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.
Sites / Locations
- Toulouse University Hospital GerontopoleRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Active RGn600
Sham
RGn600 with a 10 Hz-pulsed wave mode light emission
Inactivated RGn600