Novel Personalized Non Invasive Combined Magnetic and Electrical Stimulation of the DMN in Mild AD Patients

Prior treatment

• Hospitalization or change in chronic concomitant medications one month before the screening or during the screening period

Other illness

• Failure to undergo screening or baseline exams
• A current DSM-V diagnosis of major depression, schizophrenia, or bipolar disorder.
• Clinically significant, advanced, or unstable disease that may interfere with primary or secondary variable assessments and may affect the assessment of the patient's clinical or mental state, or expose the patient to special risk, such as:
  • Disability that may prevent the patient from completing all study requirements (e.g., blindness, deafness, severe language difficulties, etc.);
  • Opioid-containing analgesics
  • Suspected or known drug or alcohol abuse, i.e., more than about 60 g of alcohol (about 1 liter of beer or 500 ml of wine) per day, indicated by a high mean corpuscular volume (MCV) above the normal value at screening;
  • Any condition that, in the investigator's judgment, makes the patient unsuitable for inclusion

Lab values

• Clinical, laboratory, or neuroimaging results consistent with:
  • other primary degenerative dementia (Lewy body dementia, frontotemporal dementia, Huntington's disease, Creutzfeldt-Jakob disease, Down syndrome, etc.);
  • other neurodegenerative conditions (Parkinson's disease, amyotrophic lateral sclerosis, etc.);
  • orthostatic hypotension and autonomic disorders
  • cerebrovascular disease (major infarction, a strategic infarction or multiple lacunar infarctions, extensive white matter lesions \> one quarter of total white matter);
  • other central nervous system diseases (severe traumatic brain injury, tumors, subdural hematoma, or other space-occupying processes, etc.);
  • seizure disorder.
  • Other infectious, metabolic, or systemic diseases affecting the central nervous system (syphilis, existing hypothyroidism, current vitamin B12 or folate deficiency, serum electrolytes outside normal limits, juvenile diabetes, etc.).

• Patients with a diagnosis of AD according to IWG criteria
• 20 \> MMSE \< 28
• Patients with CSF specific biomarker profile or with a positive Amyloid Pet Scan consistent with the presence of amyloid pathology
• Global Clinical Dementia Rating (CDR) ≤1
• Previous decline in cognition for more than six months as documented in patient medical records
• A caregiver available and living in the same household or interacting with the patient and available
• Patients living at home or nursing home setting without continuous nursing care
• General health status acceptable for a participation in a 6-month clinical trial
• Stable pharmacological treatment for at least one month prior to screening
• No regular intake of prohibited medications.
• Signed informed consent by the patient. If there are any doubts that the patient is mentally capable of giving informed consent, the patient will be examined and verified to be mentally capable by an independent physician/ neurologist, prior to the initiation of any study specific procedure. Signed consent of the caregiver