CompletedNot Applicable

ExAblate Blood-Brain Barrier Opening for Treatment of Alzheimer's Disease

Canada35 participantsStarted 2018-12-06

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

Who can participate

Age range50 Years – 85 Years

SexALL

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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
✕. Significant depression and at potential risk of suicide

What they're measuring

Device and procedure related adverse events

Timeframe: 6 months

Trial details

NCT IDNCT03739905

SponsorInSightec

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-09

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