Alzheimer Disease
Conditions
Keywords
Magnetic Resonance guided Focal Ultrasound (MRgFUS), Alzheimer's Disease, ExAblate, Blood Brain Barrier
Brief summary
The purpose of this study is to evaluate the safety and efficacy of the ExAblate® Model 4000 Type 2.0 system as a tool to open the blood-brain barrier (BBB) in patients with probable Alzheimer's Disease (AD).
Detailed description
This study is a prospective, open label, single-arm, non-randomized, phase IIa trial to evaluate the feasibility, safety and efficacy of repeated, BBB opening using the ExAblate® Model 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 a single center in Canada and will enroll up to 30 patients.
Interventions
Focal Ultrasound (FUS) involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct targets to induce BBB disruption.
Sponsors
InSightec
Focused Ultrasound Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device and procedure related adverse events | 6 months | Rate of adverse events following each treatment through end of study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BBB Disruption and Closure | Immediately after the end of each ExAblate treatment and 24 hours after each treatment | MRI images post ExAblate treatment to verify that the BBB was disrupted and subsequently closed |
| Change in Alzheimer's Disease Assessment Scale-Cognition | Baseline and 6 months | Mental cognition assessment |
| Change in Amyloid Tracer uptake | Baseline and Day 8 following the third treatment | PET scan analysis comparing the Amyloid Tracer uptake on images taken at baseline and after the last treatment |
Countries
Canada
Outcome results
None listed