Single-center, single-group, exploratory clinical trial to confirm the efficacy and safety of the focused ultrasound stimulation system (NS-US200) to improve cognitive function in Alzheimer's disease patients after low-intensity focused ultrasound stimulation in the left dorsolateral prefrontal cortex
- Conditions
- Mental and behavioural disorders
- Registration Number
- KCT0008169
- Lead Sponsor
- eurosona
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 10
1) Patients with Alzheimer's disease between 55 and 90 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-?)
3) Dementia patients with a Mini Mental State Examination 2nd (MMSE-?) less than 25
4) Patients with a Clinical Dementia Rating (CDR) less than 1
5) Patients taking acetylcholinesterase inhibitors (ACEI) and NMDA receptor antagonists (NMDA receptor inhibitors) consistently have the same treatment and dosage for more than 3 months prior to the screening date
6) Those who can read and understand the informed consent form, and who is capable of language ability to respond to the questionnaire
7) Those who can be accompanied by a guardian when visiting a research institution during the clinical trial process and who can be helped by the guardian to proceed with the clinical trial process normally
8) Those who voluntarily decide to participate in this clinical trial and agreed to the informed consent form in writing and can participate in the entire clinical trial
1) Having a history of epileptic seizures, presently taking anticonvulsants
2) Presently taking medication at the department of psychiatry for diseases such as severe depression and schizophrenia other than the inclusion criteria
3) Having a history of serious diseases such as cancer/tuberculosis
4) Those not suitable for Magnetic Resonance Imaging (MRI)
5) Detection of clinical calcification of the brain on computed tomography (CT) or simple radiography
6) Long-term use of drugs (e.g., anticholinergic drugs, etc.) that will cause cognitive decline can affect cognitive impairment for more than 10 years
7) Those with difficulties to accurately evaluate cognitive function due to the drug being administered
8) History of transient ischemic attack, stroke or cerebrovascular disease within one year from the screening date
9) Cerebral damage due to trauma, ischemia, hypoxia, etc.
10) Difficulty reading the text even with glasses due to decreased vision
11) Difficulty hearing even with hearing aid due to hearing impairment
12) Difficulty breathing while sitting still
13) Suicide attempt within 6 months of the screening date
14) Who participated in other clinical trials within 30 days from the screening date
15) Women of childbearing potential who do not consent to using contraception *in a medically acceptable manner during this trial
*Medically accepted contraceptive methods: condoms, oral contraception for at least 3 months or more, using injectable or injectable contraceptives, installing intrauterine contraceptives, etc.
16) Pregnant or breastfeeding
17) In addition to the above, those who are judged to be inadequate for participating in the clinical trial by a principal investigator or the person in charge
18) Negative for amyloid plaque on Amyloid PET-CT
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in MMSE-II (Mini Mental State Examination 2nd) test scores;Changes in K-NPI (Korean Neuropsychiatric Inventory) test scores;Changes in MOCA-K (Korean version of Montreal Cognitive Assessment) test scores;Changes in SNSB (Seoul Neuropsychological Screening Battery) test scores
- Secondary Outcome Measures
Name Time Method Changes in beta-amyloid on Amyloid PET-CT;Changes in brain glucose metabolism on FDG PET-CT;Occurrence and frequency of adverse events