Phase 2 clinical trial for optimal and dose exploration of Mecasin for mild and moderate Alzheimer's disease

Not Applicable

• Conditions: Mental and behavioural disorders

• Registration Number: KCT0008433
• Lead Sponsor: Wonkwang University, Gwangju Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1) According to DSM-5 and NINCDS-ADRDA standards, Alzheimer's disease is caused by a specialist.
Adult men and women aged 55 or older and under 80 years of age diagnosed
2) A person with a Korea-MMSE (Korea-Mini Mental State Examination) Score of 10-23 and a CDR (Clinical Dementia Rating) score of 0.5-2 during a screening visit, and a moderate cognitive impairment
3) Those with a Hachinski Ischemic Scale of 4 or less during the screening visit
4) Acetylcholinesterase Inhibitors (AChEI) or Memantine for at least 3 months based on screening visits
a person who maintains a dose of medication
5) During the clinical trial process, a guardian can be accompanied when visiting a research institution, and the clinical trial process can be carried out.
a man of wealth
6) A person who voluntarily agrees in writing to the consent form of the clinical trial subject and his/her legal representative

Exclusion Criteria

1) A person with a history of malignancy within five years of a screening visit
2) A person with degenerative brain diseases such as vascular dementia, Parkinson's disease, Huntington's disease, frontal cranial dementia, and Creutzfeldt-Jacob's disease, etc. due to causes other than Alzheimer's type.
3) A person who has a systemic condition that causes dementia, such as hypothyroidism, vitamin B12 or folate deficiency, niacin deficiency, hyperkalemia, neuropathy, and human immunodeficiency virus disease.
4) Psychiatric disorders diagnosed by DSM-5 are schizophrenia, delusional disorders, depression, bipolar disorder, alcohol, or
A person who has a history of major psychiatric disorders, such as substance abuse disorder;
5) A person who has a history of neurological disorders such as epilepsy, local brain damage, head trauma, etc.
6) Those with brain MRI (or CT) scan results suggesting clinically significant structural CNS disease (e.g., brain)
Large vascular disease [major vascular (cortical) infarction diameter >10 mm], previous major bleeding [>1 cm3], cerebrovascular deformity, cortex
Changes suggesting hemolysis, intracranial aneurysm, intracranial tumor, and normal cerebral pressure hydrocephalus)
7) a person currently on psychotropic drugs or hormone medications
8) A person with gastrointestinal, endocrine, and cardiovascular diseases that are not controlled by diet or medication, etc.
9) Severely unstable medical conditions (clinical laboratory tests, electrocardiogram tests, chest x-rays, vital signs, etc.)
Based on the results, the doctor's judgment is based on the results
10) Diabetes patients who are not controlled by a hypoglycemic agent (blood sugar level is 126 mg/dl or higher after an empty stomach for more than 8 hours).
Blood sugar level is 200 mg/dl or glycated hemoglobin 6.5 or higher after 2 hours of test, and urine test is also required.
Those who also have diabetes detected in the company) or those with insulin-dependent diabetes.
11) Hypertension patients with systolic blood pressure exceeding 165 mmHg and diastolic blood pressure exceeding 96 mmHg
12) Those whose AST (GOT) and ALT (GPT) are above the normal upper limit.
13) Patients with chronic renal failure or those with serum creatine above the normal upper limit.
14) From the time of this registration to the 12th week after the final administration of the clinical trial drug throughout the clinical trial period, medically
Those who do not agree to contraception in a permitted manner, those who have sperm donation and plans to conceive, pregnant or lactating.
Medically permitted contraception method: oral contraception lasting at least 6 months, for injection or insertion.
Use of contraceptives, installation of intrauterine contraceptives, etc.)
15) A person who participated in another clinical trial within 3 months before the start of the study
16) People with hypersensitivity or allergies to research-related drugs
17) If you have a disease that may affect the absorption of a drug or have indigestion after undergoing surgery related thereto
Let's.
18) Those who are not suitable to participate in this clinical trial at the discretion of the researcher
19) A person who has a family member, relatives, or friends who participates in this study

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amount of change inAlzheimer's Disease Assessment Scale-cognitive subscalepreliminary Korean version : ADAS-K-cog

Secondary Outcome Measures

Name	Time	Method
mini mental state examination:KMMSE variation;Korean Instrumental Activities of Daily Living(K-IADL) variation;Neuropsychiatric Inventory Questionare(NPI-Q) variation;Clinical Dementia Rating (CDR) variation;Global Deterioration Scale (GDS) variation;Korean version of Quality of Life-Alzheimer's Disease (KQOL-AD) variation;Revised-Memory and Behavior Problem Checklist(R-MBPC) variation;Short form Geriatric Depression Scale(S-GDpS) variation