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

Inclusion criteria

• Signed written informed consent prior to beginning study-related procedures.
• Female and male subjects aged ≥ 60
• Able to comply with the study protocol, in the investigator's judgment.

Exlusion Criteria:

• Current or past history of: active psychosis, intellectual disability, bipolar disorder, alcohol abuse, addiction to psychoactive substances or any other major psychiatric condition.
• 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.
• Anticancer treatment within 12 months prior to the screening visit.
• Clinically relevant serious co-morbid medical conditions within 3 months prior to the screening visit, including, but not limited to:

• current active or persistent infection
• clinically significant cardiac disease including unstable angina, acute myocardial infarction, congestive heart failure (NYHA III or NYHA IV), uncontrolled arrhythmia, uncontrolled hypertension (> 2nd stage),
• severe liver disease
• severe renal impairment
• uncontrolled diabetes
• chronic obstructive pulmonary disease (COPD)
• 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.
• Permanent usage of benzodiazepines or cholinergic drugs.
• Insomnia
• 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.
• A serious communication barrier.
• 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.

• Currently in a study of similar investigational device or investigational product which could interfere in study integrity.