Alzheimer Disease
Conditions
Brief summary
This study was focused on comparing the efficacy of repetitive Focused ultrasound mediated BBB opening in alzhemer's disease in increased number of treatment session and shorter intervals.
Interventions
PROCEDUREMR guided low intensity focused ultrasound
Low intensity focused ultrasound opens the blood brain barrier
Sponsors
Yonsei University
Kyung Won Chang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age over 50 to 85 * MMSE below 23 * FBB-PET positive * FDG-PET shows alzheimer -induced neurodegeneration * Dementia or cognitive impairment due to alzhemer's disease * participants who have taken over 3 months of medication related with cognitive improvement * Someone who can express their sensations during the procedure. * Individuals who have voluntarily decided to participate in this clinical trial and have provided written consent on the informed consent form. * Individuals with a commitment to adhere to the clinical trial protocol.
Exclusion criteria
* If any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Standard Uptake Value Ratios (SUVR) on FBB-PET | Screening, 2weeks after final procedure | Conducting FBB (18F-Florbetaben)-PET scans to confirm the presence of Amyloid beta protein (Aβ) plaques in the brain, the study compares and analyzes the global and regional standard uptake value ratios (SUVR) before the first procedure (Visit 1) and after the third procedure (Visit 12). The cerebellar gray matter is used as a reference region, and the analysis includes whole-brain as well as regional (Frontal/Temporal) SUVR. |
| Changes in CGA-NPI (Caregiver-administered neuropsychiatric inventory) Scores and Percentage Change | Screening, 2weeks after every session, 2months after final session | To assess the cognitive function of participants, the CGA-NPI (Caregiver-Administered Neuropsychiatric Inventory) test is administered before the first procedure (Visit 1) and compared to scores after the first, second, and third procedures (Visits 4, 8, 12, 13). Changes in CGA-NPI scores and percentage changes (%) are investigated at each assessment point, with responses provided by the same participant's caregiver. Higher scores indicate severity of neuropsychiatric symptoms and 0 indicates no symptom. |
| Changes in K-MMSE(Korean version of Mini Mental State Exam) Test Scores and Percentage Change | Screening, 2months after final session | For evaluating cognitive function, the K-MMSE (Korean version of Mini Mental State Exam) test is conducted before the first procedure (Visit 1) and compared to scores after the third procedure (Visits 12, 13). Changes in K-MMSE scores and percentage changes (%) are examined. Higher scores indicate better cognition. |
| Changes in SNSB(Seoul Neuropsychological Screening Battery)Test Scores and Percentage Change | Screening, 2months after final session | Assessing cognitive function, the SNSB (Seoul Neuropsychological Screening Battery) test is performed before the first procedure (Visit 1) and compared to scores after the third procedure (Visit 13). Changes in SNSB scores and percentage changes (%) are investigated. Higher scores indicate better cognition. |
Countries
South Korea
Outcome results
None listed