KCT0005098
Completed
N/A
Pilot study of focused ultrasound stimulator system(NS-US100) to evaluate efficacy and safety of BBB (Blood-Brain Barrier) disruption for Alzheimer's disease patients
The Catholic University of Korea, Incheon St. Mary's Hospital0 sites15 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The Catholic University of Korea, Incheon St. Mary's Hospital
- Enrollment
- 15
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adults between 65 and 85 years of age
- •2\. Those who were diagnosed with probable Alzheimer's disease according to the Neurological and Communicative Disorders and Stroke\-Alzheimer’s Disease and Related Disorders Association (NINCDS\-ADRDA) and meet the criteria for dementia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM\-IV)
- •3\. Patients with a clinical dementia rating (CDR) 1\-3 and MMSE less than 20 to exclude mild cognitive impairment and early Alzheimer's disease
Exclusion Criteria
- •1\. Presence of underlying lesions in the brain (eg, cerebral hemorrhage, cerebral infarction, cerebrovascular malformation, brain tumor, etc.) on magnetic resonance imaging (MRI)
- •2\. Taking drugs that may cause cognitive impairment (eg, anticholinergic drugs)
- •3\. History of epileptic seizure, presence of depression or psychiatric symptoms, visual hallucination, and cognitive decline
- •4\. History of psychiatric disorders other than what is specified in inclusion criteria
- •5\. Those who have major medical illnesses such as cancer / tuberculosis
- •6\. Those with difficulties to accurately evaluate cognitive function due to the drug being administered
- •7\. Those who have contact dermatitis or problems related to sensitive skin
- •8\. Those not suitable for MRI
- •9\. Pregnancy
- •10\. Calcification in the brain on computed tomography (CT)
Outcomes
Primary Outcomes
Not specified
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