Efficacy of RGn600 in Patients With Mild-to-moderate Alzheimer's Disease

Prior treatment

• 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

Other illness

• 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

Other

• 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.

• 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.