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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005098

Enrollment

Registered

2020-06-09

Start date

2019-08-19

Completion date

Unknown

Last updated

2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Subjects are injected with 10 µL/kg of Definity® microbubble intravenously (DuPont Pharmaceuticals Company, Wilmington, DE, and Bristol-Myers Squibb Medical Imaging, Inc., Billerica,

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
BBB disruption on T1 dynamic contrast enhanced MRI	—

Secondary

Measure	Time frame
Adverse events;Brain beta-amyloid levels assessed by amyloid-PET;Brain glucose metabolism assessed by FDG-PET;Cognitive function assessed by neuropsychological test	—

Countries

Korea, Republic of

Contacts

Public ContactHyeonseok Jeong

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

hyeonseok.s.jeong@gmail.com+82-32-280-5243

Outcome results