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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Yonsei University
Age
50–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
1. severe ischemic changes
2. active or chronic infection/inflammation
3. acute or chronic hemorrhage
4. tumor/space occupying lesion
5. meningeal enhancement
6. 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
