Alzheimer disease
Conditions
Interventions
Experimental group:Bushen Huazhuo Formula: 2 bags per time, 2 times daily, taken continuously for 24 weeks.
Sponsors
Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Age range from 50 to 85 years old, regardless of gender. 2.Meet the probable Alzheimer’s disease (AD) diagnostic criteria according to the National Institute on Aging-Alzheimer’s Association (NIA-AA) (2011). 3.Meet the TCM syndrome differentiation of Dementia with Kidney Deficiency and Phlegm Obstruction. 4.Mini-Mental State Examination (MMSE) score of =10 and =26, adjusted based on educational level, with scores of =23 (primary school), 24 (middle school), and 26 (university). 5.Clinical Dementia Rating (CDR) score of 1 or 2. 6.Hachinski Ischemia Score = 4. 7.Completion of at least primary school education or higher and ability to complete the cognitive ability assessments and other tests as required by the protocol. 8.Participants should have a stable and reliable caregiver available for at least 4 days per week, with a minimum of 2 hours per day, to assist the researchers in conducting the relevant scale assessments. 9.If currently receiving cholinesterase inhibitors and/or memantine treatment, a stable dose must have been maintained for at least 3 months. 10.Willingness to voluntarily participate in this clinical trial, cooperate with the researchers in carrying out the study, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Non-AD causes of dementia (such as vascular dementia, Lewy body dementia, frontotemporal dementia, and mixed dementia). 2.Cognitive impairment due to other reasons: central nervous system infections (such as HIV, syphilis, etc.), Creutzfeldt-Jakob disease, Huntington’s disease and Parkinson’s disease, epilepsy, dementia due to traumatic brain injury, other physicochemical factors (drugs, alcohol, carbon monoxide, etc.), significant systemic diseases (hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial space-occupying lesions (subdural hematoma, brain tumors), endocrine system disorders (thyroid diseases, parathyroid diseases), as well as dementia caused by vitamin B12 and folate deficiency or any other known causes. 3.Co-existing severe mental disorders, such as major depression, severe anxiety disorders, bipolar disorder, schizophrenia, etc. 4.Presence of brain infarction, hemorrhage, focal lesions, or infection observed in the MRI scan within the past 12 months. 5.Concurrent unstable or severe cardiovascular, pulmonary, hepatic, renal, hematopoietic system diseases (including unstable angina, uncontrolled asthma, active gastrointestinal bleeding, etc.), or malignant tumors. 6.History of alcohol or drug abuse or dependence within the past 2 years. 7.Use of other medications that may interfere with cognition, such as antiepileptic drugs, anti-Parkinson’s drugs, antipsychotic drugs, or a documented history of the use of Chinese herbal medicine/proprietary Chinese medicine with known cognitive-enhancing effects. 8.Abnormal liver or kidney function: ALT or AST = 1.5 times the upper limit of normal, or SCr > the upper limit of normal. 9.Known or suspected history of allergy or severe adverse reactions to the investigational drug, or individuals with allergic tendencies. 10.Participation in other drug clinical trials within the 3 months prior to screening. 11.Pregnancy, lactating women, or individuals with recent plans for pregnancy. 12.Other conditions deemed inappropriate for participation in this trial by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| score of the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog); | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Dementia Rating-Sum-of-Boxes (CDR-SB);score of the Mini-mental State Examination (MMSE);activities of daily living (ADL);the pattern element scale for dementia (PES-D/11); | — |
Countries
China
Contacts
Public ContactRui GAO
Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine
Outcome results
None listed