ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease
ConditionAlzheimer Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorInSightec
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
MRI Findings
Presence of unknown or MR unsafe devices anywhere in the body
Significant cardiac disease or unstable hemodynamic status
Relative contraindications to ultrasound contrast agent or PET amyloid tracer
Trial design
Design model
Sequential
Treatments tested in this trial
Blood Brain Barrier (BBB) Disruption
DeviceFocal Ultrasound (FUS) involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct targets to induce BBB disruption.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Blood Brain Barrier (BBB) DisruptionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Device and procedure related adverse events
Rate of adverse events following each treatment through end of study
Time frame
5 yearsOther outcomes
1
BBB Disruption and Closure
MR images post-procedure to verify that the BBB was disrupted and subsequently closed within 24 hours.
Time frame
Immediately after the end of each ExAblate treatment and 24 hours post treatment Source ClinicalTrials.gov