A Study Evaluating the Efficiency and Safety for the VGuard Device in Alzheimer's Disease.

Inclusion Criteria

• •1. Signed written informed consent prior to beginning study-related procedures.
• •2. Female and male subjects aged ≥ 60
• •3. Able to comply with the study protocol, in the investigator\'s judgment.
• •Exlusion Criteria:
• •1. Current or past history of: active psychosis, intellectual disability, bipolar disorder, alcohol abuse, addiction to psychoactive substances or any other major psychiatric condition.
• •2. Current or past history of any neurological disorder other than dementia, such as: epilepsy, stroke, Transient Ischemic Attack (TIA), Huntington\'s disease, Hakim syndrome, Parkinson\'s disease, multiple sclerosis, intracranial hematoma or brain lesions; and history of previous neurosurgery or head trauma that resulted in residual neurologic impairment.
• •3. Anticancer treatment within 12 months prior to the screening visit.
• •4. Clinically relevant serious co-morbid medical conditions within 3 months prior to the screening visit, including, but not limited to:
• •1. current active or persistent infection
• •2. clinically significant cardiac disease including unstable angina, acute myocardial infarction, congestive heart failure (NYHA III or NYHA IV), uncontrolled arrhythmia, uncontrolled hypertension (\> 2nd stage),
• •3. severe liver disease
• •4. severe renal impairment
• •5. uncontrolled diabetes
• •6. chronic obstructive pulmonary disease (COPD)
• •7. other metabolic, endocrine or systemic diseases affecting the central nervous system (present hypothyroidism), which in the physician\'s opinion may be the cause of dementia.
• •5. Permanent usage of benzodiazepines or cholinergic drugs.
• •6. Insomnia
• •7. Metal implants (excluding dental fillings) or devices such as pacemaker, medication pump, nerve stimulator, TENS unit, ventriculo-peritoneal shunt, cochlear implant, unless cleared by the study MD.
• •8. A serious communication barrier.
• •9. Clinically significant abnormalities at screening (Visit A) in laboratory tests, including: vitamin B12 deficiency or other laboratory abnormalities of possible clinical significance should be discussed with Principal Investigator to determine eligibility.
• •I 0. Positive pregnancy test ( for female of childbearing potential confirmed in medical interview) or is known from medical interview that woman is lactacting or pregnant.
• •11\. Currently in a study of similar investigational device or investigational product which could interfere in study integrity.