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 个研究点目标入组 15 人开始时间: 待定最近更新: 2021年8月30日

试验速览

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•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

•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)
•11. Allergic reaction to contrast media such as Definity or Gadovist

发起方

The Catholic University of Korea, Incheon St. Mary's Hospital