ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease

This is a prospective, multi-center, single-arm study to evaluate the safety and efficacy of
BBB disruption using the ExAblate Model 4000 Type 2.0 (220 kHz) system. Patients with
diagnosis of Probable Alzheimer's Disease may qualify for a clinical trial to have three
serial ExAblate BBB disruption procedures in specific areas in the brain. This study will be
conducted at up to 4 sites in the United States and will enroll up to 10 patients.

Inclusion Criteria:

1. Male or Female between 50-85 years of age

2. Probable Alzheimer's Disease (AD)

3. If taking concurrent Alzheimer's medication, has been on the medication for at least 2
months with a stable dose for at least 3 months

4. Able to communicate sensations during the ExAblate MRgFUS procedure

5. Ambulatory

Exclusion Criteria:

1. MRI Findings

2. Presence of unknown or MR unsafe devices anywhere in the body

3. Significant cardiac disease or unstable hemodynamic status

4. Relative contraindications to ultrasound contrast agent or PET amyloid tracer

5. History of a bleeding disorder

6. History of liver disease

7. Known cerebral or systemic vasculopathy

8. Significant depression and at potential risk of suicide

9. Any contraindications to MRI scanning

10. Any contraindication to lumbar puncture for collection of cerebral spinal fluid

11. Untreated, uncontrolled sleep apnea

12. History of seizure disorder or epilepsy

13. Severely Impaired renal function

14. 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

15. Chronic pulmonary disorders

16. Positive human immunodeficiency virus (HIV)

17. Known apolipoprotein E allele (ApoE4) homozygosity