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

Not Applicable

Completed

• Conditions: Diseases of the nervous system

• Registration Number: KCT0005098
• Lead Sponsor: The Catholic University of Korea, Incheon St. Mary's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-02-18
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BBB disruption on T1 dynamic contrast enhanced MRI

Secondary Outcome Measures

Name	Time	Method
Adverse events;Brain beta-amyloid levels assessed by amyloid-PET;Brain glucose metabolism assessed by FDG-PET;Cognitive function assessed by neuropsychological test