Status:
UNKNOWN
Assessment of Initial Efficacy and Safety of High Intensity Focused Ultrasound 'ExAblate 4000 Type 2' for Blood Brain Barrier Disruption in Patients With Alzheimer's Disease
Lead Sponsor:
Yonsei University
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50-85 years
Phase:
NA
Brief Summary
The proposed study is to evaluate initial efficacy and safety of the BBB disruption with transcranial MRI-guided focused ultrasound (ExAblate 4000 type 2.0) in patients with Alzheimer's disease. This...
Eligibility Criteria
Inclusion
- Age between 50 and 85 years, inclusive.
- Total score of 23 or less on the Korean version of Mini Mental state Exam (K-MMSE)
- FBB (18F-Florbetaben)-PET test result positive
- FDB (18F-Fluorodeoxyglucose)-PET test results suspected of Alzheimer disease-induced neurodegeneration
- Mild cognitive impairment or dementia caused by Alzheimer's disease
- A participant who has been given a drug at a stable dose for at least three months to improve symptoms of Alzheimer's disease
- Able to communicate during the ExAblate BBB disruption procedure
- Able and willing to give informed consent
- Able to attend all study visits
Exclusion
- CGA-NPI (Caregiver-Administrated Neuropsychiatry Inventory) severity score of more than 2 points for any of "Delusion", "Hallucination" or "Agitation/Aggression"
- Known sensitivity/allergy or contraindications to MRI contrast agent(Gadovist®) or the ultrasound contrast agent (Definity®)
- Contraindications to MRI such as non-MRI compatible implanted devices.
- Any of the following items in MRI
- severe ischemic changes
- active or chronic infection/inflammation
- acute or chronic hemorrhage
- tumor/space occupying lesion
- meningeal enhancement
- intracranial hypotension
- More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp
- Active seizure disorder or epilepsy (seizures despite medical treatment)
- History of a bleeding disorder, coagulopathy
- Cardiac disease or unstable hemodynamics
- Severely impaired renal function with estimated glomerular filtration rate \<30 mL/min/1.73m2
- Severe brain atrophy
- HIV (Human immunodeficiency virus) positive, who have a high probability of developing HIV encephalitis due to the influx of HIV in to the brain parenchyma
- Subjects with evidence of cranial or systemic infection
- A homozygosity of Apolipoprotein E allele (ApoE4) known to have a thin blood-brain barrier
- Positive pregnancy test (women of childbearing potential)
- A participant in other clinical trials or have experience in other clinical trials within 90 days from the screening date
Key Trial Info
Start Date :
April 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04526262
Start Date
April 10 2020
End Date
December 1 2020
Last Update
August 25 2020
Active Locations (1)
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1
Department of Neurosurgery, Yonsei University College of Medici
Seoul, South Korea