This clinical trial is designed to evaluate the initial safety and efficacy of opening the blood brain barrier (BBB) in patients with Alzheimer's disease using the ExAblate 4000 Type 2.1, a MR guided high-intensity focused ultrasound surgical device that disrupts brain tissue.
Age between 50 and 85 years
Total score of 23 or less on the K-MMSE (Korean version of the mini mental state exam)
Positive 18F-Florbetaben (FBB) PET scan
Have mild cognitive impairment or dementia due to Alzheimer's disease, each of which must meet the criteria below.
A severity score of 2 or more for any of the following items on the caregiver-administered neuropsychiatry inventory (CGA-NPI): "delusions," "hallucinations," or "agitation/aggression."
Known sensitivity/allergy to or contraindication* to the MRI contrast agent gadolinium (Gadovist® ) or ultrasound contrast agent Definity®
Have a standard contraindication to MR imaging, such as implanted metal devices that are incompatible with MRI.
Sensitivity/allergy to or contraindication to local anesthetics and any anesthetic used when conscious sedation is required during application of an investigational medical device in a clinical trial