RecruitingNot Applicable

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

United States50 participantsStarted 2018-09-28

Plain-language 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).

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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
. History of a bleeding disorder
. History of liver disease
. Known cerebral or systemic vasculopathy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Device and procedure related adverse events

Timeframe: 5 years

Trial details

NCT IDNCT03671889

SponsorInSightec

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-01

View on ClinicalTrials.gov More Alzheimer Disease trials