Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for Mild Cognitive Impairment or Mild Alzheimer's Disease Undergoing Standard of Care Monoclonal Antibody (mAb) Therapy

Eligibility Criteria

• * Able and willing to give informed consent
• * Probable mild cognitive impairment due to AD
• * Modified Hachinski Ischemia Scale (MHIS) score of \<= 4
• * Mini Mental State Exam (MMSE) scores \> 21+.
• * Short form Geriatric Depression Scale (GDS) score of \<= 7
• * Amyloid PET scan consistent with the presence of β-amyloid (A+)
• * Able to communicate sensations during the Exablate MRgFUS procedure
• * Able to attend all study visits (i.e., life expectancy of 1 year or more)
• * MRI findings:
• * Significant cardiac disease or unstable hemodynamic status
• * History of a liver disease, bleeding disorder, coagulopathy or a history of spontaneous hemorrhage
• * Known cerebral or systemic vasculopathy
• * Significant depression (GDS \> 7) and/or at potential risk of suicide (C-SSRS \> 2)
• * A severity score of 2 or more on any of the 'Delusions', 'Hallucinations' or 'Agitation/Aggression' subscales of the Neuropsychiatry Inventory (NPI-Q)
• * Known sensitivity/allergy to gadolinium(gadobutrol), DEFINITY or its components, or 18F-florbetaben.
• * Known hypersensitivity to DEFINITY or its components.
• * Any contraindications to MRI scanning
• * Untreated, uncontrolled sleep apnea
• * History of untreated or uncontrolled seizure disorder or epilepsy.
• * Impaired renal function
• * Does not have a reliable caregiver
• * Currently in a clinical trial involving an investigational product or non-approved use of a drug or device or in any other type of medical research.
• * Respiratory: chronic pulmonary disorders
• * History of clinically significant recent drug or alcohol use disorder who may be at higher risk for seizure or infection.
• * Positive human immunodeficiency virus (HIV) which can lead to increased entry of HIV into the brain parenchyma leading to HIV encephalitis.
• * Potential blood-borne infections, which can lead to increased entry to brain parenchyma leading to meningitis or brain abscess.