NCT03671889

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

Assessment of Safety and Efficacy of ExAblate Blood-Brain Barrier Disruption for the Treatment of Patients With Probable Alzheimer's Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: InSightec · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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 disrupt the blood-brain barrier (BBB) in patients with probable Alzheimer's Disease (AD).

Detailed description

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 8 sites in the United States and will enroll up to 30 patients.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DEVICE	Blood Brain Barrier (BBB) Disruption	Focal Ultrasound (FUS) involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct targets to induce BBB disruption.

Timeline

• Start date: 2018-09-28
• Primary completion: 2028-01-01
• Completion: 2030-01-01
• First posted: 2018-09-14
• Last updated: 2026-01-09

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study