Table 3 Inclusion and exclusion criteria

From: Blood–brain barrier opening in Alzheimer’s disease using MR-guided focused ultrasound

Inclusion criteria

 Male or female between age of 50–85

 Probable AD consistent with NIA/AA criteria

 Modified Hachinski Ischemia Scale ≤4

 Mini Mental State Exam 18–28

 Short form Geriatric Depression Scale ≤6

 If being treated with AChEI and/or Memantine, has been on medication for ≥4 months with a stable dose for ≥3 months

 Beta-amyloid deposition on [18F]-florbetaben PET in the right frontal lobe

ASA physical status classification I-III

Exclusion criteria

 Contraindications to MRI, MRI contrast, or ultrasound contrast

 MRI findings of active or acute neurological process (e.g. infection, tumor) or macrohemorrhage or >4 lobar microbleeds

 ≥30% of the skull area traversed by sonication is covered by scars, scalp disorder or atrophic scalp

 Significant cardiac disease

 Uncontrolled hypertension

 Predisposition for bleeding

 Known cerebral or systemic vasculopathy

 Frequency or severity of ≥2 on Delusion, Hallucination, or Agitation/Aggression subscales of the NPI-Q

 Impaired renal function

 Severe chronic respiratory disorders

  1. NIA/AA National Institute on Aging/Alzheimer’s Association, AChEI acetyl-cholinesterase inhibitor, ASA American Society of Anesthesiologists