Alzheimer's disease
Conditions
Interventions
Treatment group:Shenghui Yizhi Decoction + Donepezil hydrochloride tablets
Sponsors
CHINA-JAPAN FRIENDSHIP HOSPITAL
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Participate voluntarily and sign the informed consent with the guardian. If the subject cannot sign due to limited cognitive ability or other reasons, the subject is allowed to leave the signature blank and explain the reason. The guardian shall sign the reason explanation and the guardian shall sign the informed consent; (2) Age =50 years old, gender is not limited; (3) The AD diagnostic criteria proposed by (NIA-AA) were diagnosed as patients with a high probability of AD; (4) 10 points =MMSE=26 points; (5) Head MRI plain scan or oblique coronal hippocampal scan at screening showed the greatest likelihood of AD (coronal imaging of medial temporal atrophy (MTA) visual rating scale grade 1 or higher); (6) If pre-screening patients were taking psychotropic drugs, they must have maintained a stable dose for at least 4 weeks (psychotropic drugs such as antidepressants, anti-schizophrenia drugs, anti-anxiety drugs, or sedative hypnotics); (7) TCM syndrome differentiation is spleen and kidney deficiency syndrome; (8) Subjects should have a stable and reliable caregiver, or at least frequent contact with caregivers (at least 4d per week, at least 2h per day), who will help patients participate in the whole study process. The caregiver must accompany the subject to the study visit and must have sufficient interaction and communication with the subject in order to provide valuable information for each scale score.
Exclusion criteria
Exclusion criteria: (1) non-AD induced memory and cognitive decline, such as diagnosis of other types of dementia, including but not limited to mixed dementia (AD-VaD), vascular dementia (VD), Parkinson's disease dementia (PDD), Lewy body dementia (DLB), Huntington's disease-related dementia, frontotemporal dementia (FTD), etc.; Diseases of the endocrine system (such as thyroid disease, parathyroid disease) and dementia caused by folic acid, vitamin B12 deficiency or any other cause; There is a disturbance of consciousness. (2) Have a history of seizures. (3) Persons with mental illness, including but not limited to schizophrenia, schizoaffective disorder, bipolar disorder or delirium; People with depression and anxiety. (4) During screening, MRI showed significant focal lesions: there were more than 2 infarcts with a diameter greater than 2cm, and there were infarcts in key areas such as thalamus, hippocampus, entorhinal cortex, parorhinal cortex, cornural gyrus, cortex and other subcortical gray matter nuclei. The Fazekas Scale of white matter lesion was =3. (5) Acute cardiovascular and cerebrovascular events (such as unstable angina pectoris, severe arrhythmia, myocardial infarction, transient cerebral ischemia or ischemic stroke, etc.) occurred within 3 months before screening. (6) Uncontrolled hypertension or hypotension (systolic blood pressure =150mmHg or <90mmHg, or diastolic blood pressure =100mmHg or <60 MMHG after drug treatment) at the time of screening may not be excluded if the systolic or diastolic blood pressure is slightly beyond this range but has no clinical significance. (7) The heart rate during screening was less than 50 beats/min. (8) Impaired kidney function (blood Crea is 1.5 times higher than the upper limit of normal laboratory value) or abnormal liver function (ALT and AST are 2 times higher than the upper limit of normal laboratory value). (9) Unable to complete the scale assessment prescribed by the program due to education level, uncorrectable visual impairment, and hearing impairment. (10) Unable to complete the examination required for the test due to their own reasons, such as the presence of MRI scanning contraindications. (11) Allergic to the ingredients contained in Shenghui Yizhi soup. (12) Other clinical problems that are difficult to control (such as tumors, HIV infection, treponema pallidum infection, hepatitis C virus infection, active hepatitis B or other serious chronic infectious diseases, Severe neurological, cardiovascular (e.g., unstable angina pectoris, severe arrhythmia, acute myocardial infarction, acute heart failure), respiratory (e.g., uncontrolled asthma, acute pneumonia) and other systemic diseases. (13) People who are in clinical trials of other drugs or who have participated in clinical trials of any drug (excluding vitamins and minerals) within one month or seven half-lives prior to screening, whichever is older. (14) Those who researchers believe need to be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alzheimer's disease assessment scale-cognitive subscale;TCM syndrome scale score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mini-mental State Examination;Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory, ADCS-ADL;Neuropsychiatric inventory; | — |
Countries
China
Contacts
Public ContactLI Qiubing; PENG Dantao
CHINA-JAPAN FRIENDSHIP HOSPITAL
Outcome results
None listed