Efficacy and safety of Woohwangchungsim-won combined with donepezil in behavioral and psychological symptoms of dementia: Study protocol for a randomized controlled trial
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0005669
- Lead Sponsor
- Dongguk University Ilsan Oriental Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 74
1) Male and female adults aged 50 and older diagnosed as AD (Alzheimer's disease) by a specialist according to DSM-5 and NINCDS-ADRDA standards
2) Those with a score of 10 to 26 at the screening visit, K-MMSE (Korea-Mini Mental State Examination)
3) Patients with mild Alzheimer's disease with a CDR score of 0.5-1
4) If at least one symptom score is 4 or more on the NPI's substructure scale
5) Those who have taken the tranquilizer sleeping pill at the same time from 4 weeks ago can continue to take it, but not increase the amount of the drug or use it newly.
When symptoms of BPSD worsen, quetapine or risperidone can be used, and the prescribed dose or duration is kept to a minimum.
6) Hachinski Ischemic Score 4 or less
7) Those who take Donepezil 5mg of acetylcholine esterase (AchEI) among dementia drugs and maintain a stable state without side effects after taking the maintenance dose for more than 4 weeks
* Including those who take brain function improving drugs (gliatilin, gliatamine, etc.) and cerebral blood flow improving drugs (ginexin, tanamine, etc.).
8) Those who have been kept in a stable state without changes in drugs taken for the underlying disease for more than two weeks, and have been stably administered during the test period.
9) A person who lives with a guardian who understands the requirements of the subject according to the procedure specified in the clinical trial protocol and can visit with will
10) A person who has signed a written consent after hearing the explanation of the purpose, method, and effect of the clinical trial
1) Persons with degenerative brain diseases such as vascular dementia, Parkinson's disease, and Huntington's disease due to causes other than Alzheimer's
2) Persons with systemic conditions that cause dementia, such as hypothyroidism, vitamin B12 or folate deficiency, niacin deficiency, hyperkalemia, neurosyphilis, human immunodeficiency virus disease, etc.
3) Those who have clinically clear evidence of cerebrovascular disease, or suspected territory infarct of cerebrovascular due to multiple strokes in MRI
4) Those with a history of neurological disorders such as epilepsy, local brain injury, head trauma, stroke, etc.
5) Patients with a history of major psychiatric disorders such as schizophrenia, delusional disorder, depression, bipolar disorder, alcohol or substance abuse disorder diagnosed by DSM-V
6) Those who are currently taking psychotropic drugs or hormones
7) Persons with severely unstable medical conditions (according to the judgment of the doctor in charge based on the results of clinical laboratory tests, ECG, Chest PA, vital signs, etc.)
8) Hypertensive patients with systolic blood pressure of 165mmHg and diastolic blood pressure exceeding 96mmHg
9) Diabetic patients who are not controlled by hypoglycemic drugs or insulin-dependent diabetes patients
10) Those with clinically significant liver disease or LFT exceeding twice the upper limit of normal
11) Patients with chronic renal failure or those who exceed 1.5 times the normal upper limit of creatinine in serum
12) Those with gastrointestinal, endocrine and cardiovascular diseases that are not controlled by diet or medication
13) Those who have a disease that may affect the absorption of drugs or have digestive problems after undergoing related surgery
14) Those who have hypersensitivity reactions or allergies to the components of clinical trial drugs
15) Women of childbearing age who fall under the following conditions
-Women whose pregnancy has been confirmed with serum or urine samples-Women who are lactating
-Women planning to become pregnant
-Women who do not use recognized contraception methods (eg, sterilization, intrauterine contraceptive devices, condoms, contraceptive creams, diaphragms with jelly or foam, etc. However, hormone preparations cannot be used).
16) Those who have participated in other clinical trials within 3 months prior to screening of this clinical trial
17) Those who do not understand the consent form due to mental retardation, emotional or intellectual problems, or have difficulty following the study
18) A person who judges that it is inappropriate to conduct a clinical trial by the investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PI(NeuroPsychiatric Inventory)
- Secondary Outcome Measures
Name Time Method K-MMSE(The Korean version of the Mini-Mental State Examination);SNSB(Seoul Neuropsychologic Screening Battery);ADAS-cog(The Alzheimer's Disease Assessment Scale-Cognitive Subscale);CDR-SB(Clinical Dementia Rating-Sum of Boxes);GDS(Global Deterioration Scale);K-IADL(Korean version of Instrumental Activities of Daily Living);GQOL(Geriatric Quality of Life scale);R-MBPC(Revised-Memory and Behavior Problem Checklist);EQ-5D(Euro-Quality of Life-5 Dimension);PSQI(Pittsburgh Sleep Quality Index);GDS(Geriatric Depression Scale);STAI(state-trait anxiety inventory)