Establishment of multi-institutional registry to apply dementia integrative medical service model
- Conditions
- Mental and behavioural disorders
- Registration Number
- KCT0009174
- Lead Sponsor
- Wonkwang University Jangheung Integrative Medical Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
1) Adult men and women aged 55 to 90 years old
2) Those diagnosed with major neurocognitive disorder due to Alzheimer's disease or major neurocognitive disorder due to vascular disease according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)
3) A person who decides to participate voluntarily or through the will of a legal representative and signs a consent form
- patient
1) Those with a history of malignant tumor within 5 years of the screening visit
2) People with dementia caused by causes other than Alzheimer's disease or vascular dementia, that is, degenerative brain diseases such as Parkinson's disease, Huntington's disease, frontotemporal dementia, Creutzfeldt-Jakob disease, etc.
3) Those with systemic conditions that cause dementia, such as hypothyroidism, vitamin B12 or folic acid deficiency, niacin deficiency, hyperkalemia, neurosyphilis, human immunodeficiency virus disease, etc.
4) Those with a history of major psychiatric disorders diagnosed by DSM-5, such as schizophrenia, delusional disorder, depression, bipolar disorder, alcohol or substance abuse disorder, etc.
5) Those with a history of neurological disorders such as epilepsy, focal brain damage, or head trauma
6) People with gastrointestinal, endocrine and cardiovascular diseases that cannot be controlled by diet or drug treatment
7) Persons with a seriously unstable medical condition (based on the judgment of the attending physician based on the results of clinical laboratory tests, electrocardiogram tests, chest x-rays, vital signs, etc.)
8) Those who participated in another clinical trial within 3 months before the start of the study
9) Those who are not suitable for participation in this clinical trial according to the judgment of the researcher
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method S-IAD
- Secondary Outcome Measures
Name Time Method Cognitive evaluation, daily living ability evaluation, neuropsychiatric behavior test, depression-related test, quality of life scale(MMSE, MoCA-K, GDS, S-GDpS, NPI-Q, Barthel-ADL, EQ-5D, EQ-VAS, GQOL-D, HRV );Economic evaluation;Safety evaluation(Adverse effect)