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

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

Key Facts

Primary Endpoints (CT.gov)

Secondary Endpoints

Eligibility Criteria

Inclusion 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) Exclusion Criteria: * 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 t…

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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