A clinical trial to evaluate the temporary cognitive function improvement effect and safety of a low-frequency stimulation treatment device for 9 months in patients with Alzheimer's type mild cognitive impairment receiving drug treatment.
- Conditions
- Mental and behavioural disorders
- Registration Number
- KCT0009136
- Lead Sponsor
- Ecure
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 30
Subjects must meet all of the following criteria.
1) Those between 50 and 85 years of age
2) Those who voluntarily agreed to this clinical trial and signed a written consent form
3) Those who are taking medications related to dementia or cognitive impairment at the time of screening and who meet at least one of the criteria below and are expected to receive stable administration of related medications after registration
? Those who have used acetylcholinesterase inhibitors (ACEI) and NMDA receptor inhibitors for at least 3 months prior to screening and have the same dosage
? Drugs for cognitive function treatment other than acetylcholinease inhibitors and NMDA receptor antagonists (e.g., pregabalin, gabapentin cholinealphocerate, etc.) must have the same dosage and dosage for more than 1 month before screening.
* In the case of patients taking drugs for the treatment of chronic diseases, including antidepressants, high blood pressure, diabetes, hyperlipidemia, thyroid disease, etc. in common to items ? and ?, the treatment regimen and dosage must be the same for more than 1 month before screening.
4) Those who satisfy all of the following items according to the NIA-AA (National Institute on Aging and Alzheimer's Association) diagnostic guidelines announced in 2011
? Those who meet all core clinical criteria for mild cognitive impairment due to Alzheimer's disease
- Concerns about conversion of previous functions
- Disorder in one or more cognitive areas
- Maintain independence in overall daily life functions
- Not dementia
? Those who fall into the intermediate level (a) of the research criteria for mild cognitive impairment incorporating biomarkers
- intermediate (a)
Beta-amyloid biomarker positive, neurodegeneration biomarker test not performed
5) Those whose clinical dementia rating-global score (CDR-GS) test result is 0.5 points or less
6) Those with a score of 23 or more on the Korean version of the Mini-Mental Psychological Evaluation (K-MMSE)
7) A person who can read and understand the subject description and consent form and has the language skills to answer the questionnaire.
8) A person who can be accompanied by a guardian when visiting a research institute during the clinical trial process, and whose guardian can provide assistance to proceed normally with the clinical trial process.
Subjects who meet any of the following conditions cannot participate in this clinical trial.
1) Those diagnosed with dementia (major neurocognitive disorder) according to the criteria of DSM-5 (Diagnostic and Statistical Manual, fifth edition) or ICD-10 (The International Statistical Classification of Diseases and Related Health Problems)
2) Patients with cognitive impairment due to the following diseases: Parkinson's disease, Huntington's disease, subdural hematoma, normal pressure hydrocephalus, central nervous system infection (HIV, syphilis), thyroid disease, vitamin B12 or folic acid deficiency.
3) Those with a past history of axis 1 psychiatric disorders†, including intellectual disability, schizophrenia, alcoholism, and bipolar disorder
†Axis 1 psychiatric disorder: A mental disorder with episodes, with special moments such as seizures that cause disability.
4) Those with a history of convulsions within 5 years from the screening date
5) Those who meet the following criteria in a CT or MRI imaging test within 1 year from the screening date
? Acute or subacute bleeding
? If it cannot be documented that a previous macrohemorrhage (defined as >1 cm in diameter on a T2* sequence) or a previous subarachnoid hemorrhage was not due to an underlying structural or vascular abnormality (i.e., if the finding indicates that the subject is prone to recurrent bleeding) does not imply risk).
? Four or more microbleeds (defined as 1 cm or less in diameter on T2* sequence).
? Any cortical infarction or single subcortical cerebral infarction with a diameter greater than 1.5 cm (2 cm for diffusion-weighted imaging MR)
? Superficial siderosis
? History of white matter disease, defined as a score of 3 on the Age-related white matter changes (ARWMC)
? Any findings that, in the opinion of the researcher, may be a contributing cause to the subject's dementia, may pose a risk to the subject, or may interfere with satisfactory MRI evaluation for safety monitoring.
* If there are no CT or MRI results within 1 year from the screening date, imaging is performed to check for brain disease.
* MRI images are Gradient Echo Sequence or SWI (Susceptibility-weighted image) or DWI (Diffusion-weighted image)
image)
6) Those with cerebral damage due to trauma, ischemia, hypoxia, etc.
7) Those who abused drugs* within 5 years from the date of screening
* Drugs refer to drugs such as neuroleptics, sleeping pills, narcotics, other sedatives and illegal drugs, but are not limited to these.
8) Those who received treatment for alcoholism within 5 years from the date of screening
9) People who cannot read normal letters even while wearing glasses due to decreased vision
10) People who have difficulty understanding conversations due to hearing impairment even if they wear hearing aids
11) Those who have difficulty breathing when sitting still
12) Those who have attempted suicide within 6 months from the date of screening
13) Those who are judged to have problems attaching direct current stimulation electrodes due to skin inflammatory reactions or other dermatological problems
14) Persons who are judged to have contraindications to using TENS (Transcutaneous electrical nerve stimulation) medical devices
15) Those who participated in another clinical trial within 30 days from the screening date
16) Those who have participated in other clinical trials due to mild cognitive impairment or early dementia due to Alzheimer's disease within 1 year from the
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects who achieved a score difference of -3 points or more on the Alzheimer's Disease Assessment Scale-Cognitive Domain (ADAS-Cog) at week 24 compared to the baseline between the test group (NWS20) and the control group (pseudo-control device);Proportion of subjects who achieved a score difference of -1 point or more in the Clinical Dementia Rating Scale Total Score (CDR-SB) at week 24 compared to the baseline between the test group (NWS20) and the control group (pseudo control device)
- Secondary Outcome Measures
Name Time Method Change in Korean Mini-Mental State Examination (K-MMSE) score at 12, 24, and 36 weeks compared to baseline;Change in Dementia Clinical Rating Scale-Box Total Score (CDR-SB) and Dementia Clinical Rating Scale (CDR) item scores at 12, 24, and 36 weeks compared to baseline;Change in Alzheimer's Disease Assessment Scale-Cognitive Domain (ADAS-Cog) score at 12, 24, and 36 weeks compared to baseline