None listed
Conditions
Interventions
Drug : Acetylcholinesterase inhibitors and Kamiguibitang(Kyungbang pharmaceutical). KGT 1Pk for once. three times a day, for 24weeks, per os.
Acetylcholinesterase inhibitors and Placebo(Kyungbang phar
Sponsors
Kyung Hee University Oriental Medicine Hospital at Gangdong
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A person diagnosed with mild AD(Alzheimer's disease) by a neurologist, through SNSB(Seoul Neuropsychologic Screening Battery, and NINCDS-ADRDA(National Institue of Neurological and Communicative Disorders and Stroke and Alzheimer’s Disease and Related Disorders Association). - CDR (Clinical Dementia Rating) = 0.5~1 - Since there is no absolute value of K-MMSE(Korean version Mini–Mental State Examination), GDS(Global Deterioration Scale), CDR(Clinical Dementia Rating) for diagnosis of mild AD, various criteria are applied in each clinical studies. This study is conducted for patients who are regarded as mild AD assessed with CDR among those diagnosed with AD by neurologist using NINCDS-ADRDA. 2) Subjects who take acetylcholinesterase inhibitors(AchEI) including Donepezil, Rivastigmine, Galantamine, and those who are stable without any side effects after more than 4 weeks of administration. * Subjects who take medications such as circulatory improvement agents(Ginexin, Tanamine, etc.) and nootropics(Gliatamin, Gliatilin, etc.) are also included. 3) Those who have been stable for the past 2 weeks or more without any change inthe drug used for the underlying disease, and who are planned to be stable during this clinical trial. 4) Subjects who have no problem with communication 5) Subjects who are eligible for MRI(magnetic resonance imaging) scan.
Exclusion criteria
Exclusion criteria: 1) Those with brain disorders that cause other neurological symptoms other than cognitive dysfunction 2) Patients with degenerative brain disease such as Parkinson's disease, Huntington's chorea, Down syndrome, and Creutzfeldt-Jakob disease on history and neurological examination 3) Cerebral trauma due to hypoxia such as cerebral trauma and carbon monoxide poisoning, vitamin deficiency, infectious diseases such as neurosyphilis or encephalitis, brain tumor, endocrine metabolic disease, mental retardation 4) If there is evidence of clinically evident cerebrovascular disease, or if there is suspicion of a territorial infarct of cerebral blood vessels due to multiple strokes on MRI(magnetic resonance imaging) 5) Patients with a history of convulsive disease (except for febrile convulsions in childhood) 6) Those with a history of depression or who are currently suffering from depression 7) Those with mental illness or who have behavioral problems requiring psychotropic medication 8) Persons with physical disabilities that cause life threatening and require immediate treatment. 9) Patients with uncontrolled hypertension 10) Patients with Heart or kidney disease 11) Patients with edema 12) Those with gastrointestinal symptoms (anorexia, stomach discomfort, nausea, abdominal pain, diarrhea, etc.) 13) Those who are taking medications that may cause hypokalemia or myopathy. 14) Persons with hypersensitivity to the components of clinical trial medicines 15) Those with possible pregnancy 16) Patients with clinically significant abnormalities in blood chemistry [SGPT(Serum Glutamic Pyruvic Transaminase) / SGOT(Serum Glutamic Oxaloacetic Transaminase)] : more than 2 times the normal upper limit, serum creatinine: 10% of the normal upper limit) 17) Those who participated in other clinical trials within 4 weeks 18) Those who are illiterate 19) Those who take NDMA receptor antagonist(Memantine) 20) Those who were considered inadequate by the main investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SNSB(Seoul Neuropsychologic Screening Battery);KQol-AD(Korean version of Quality of Life-Alzheimer's Disease), CGA-NPI(Caregiver-Administered Neurophychiatric Inventory);AST/ALT, glucose, BUN, creatinine, Na, K, Cl, LDH, CPK | — |
Secondary
| Measure | Time frame |
|---|---|
| brain metabolites, neurotransmitters, cerebral blood flow;amyloid ß(Aß) protein, tau protein, HMGB, SERF 1A, cholesterol derivatives | — |
Countries
Korea, Republic of
Contacts
Public ContactTae Bin Yim
Kyung Hee University Oriental Medicine Hospital at Gangdong
Outcome results
None listed