NCT03739905Completed
ExAblate Blood-Brain Barrier Opening for Treatment of Alzheimer's Disease
A Phase IIa Study to Evaluate the Safety and Efficacy of Blood-Brain Barrier (BBB) Opening Using Transcranial MR-Guided Focused Ultrasound in Patients With Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 21 Jan 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 35 (actual)
- First submitted
- 2 Nov 2018
- Start date
- 6 Dec 2018
- Primary completion date
- 9 Apr 2025
- Lead sponsor
- InSightec
- Diseases
- Alzheimer disease
- NCT number
- NCT03739905
What you commit to
- Study type: Interventional
- Participants enrolled: 35
- From 6 Dec 2018 to the primary completion date, 9 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Significant cardiac disease or unstable hemodynamic status
- History of a bleeding disorder
- History of liver disease
- History of seizure disorder or epilepsy
- Chronic pulmonary disorders
- Positive human immunodeficiency virus (HIV)
Other
- MRI Findings
- Presence of unknown or MR unsafe devices anywhere in the body
- Relative contraindications to ultrasound contrast agent or PET amyloid tracer
- Known cerebral or systemic vasculopathy
- Significant depression and at potential risk of suicide
- Any contraindications to MRI scanning
- Any contraindication to lumbar puncture for collection of cerebral spinal fluid
- Untreated, uncontrolled sleep apnea
- Severely Impaired renal function
- Known apolipoprotein E allele (ApoE4) homozygosity
Who the study is looking for
- Male or Female between 50-85 years of age
- Probable Alzheimer's Disease (AD)
- 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
- Able to communicate sensations during the ExAblate MRgFUS procedure
- Ambulatory
Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Division of Neurosurgery, Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.