Concomitant Behavioral and Psychological Symptoms of AD
Conditions
Interventions
treatment group:Yokukansan
Placebo group:Placebo
Sponsors
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged 40-85 years, regardless of gender; 2. Education level of primary school or above; 3. Meets the diagnostic criteria for probable Alzheimer's disease (AD) dementia as defined by the National Institute on Aging and Alzheimer's Association (NIA-AA) in 2011; 4. MMSE total score between 5 and 24; 5. Hachinski Ischemia Scale (HIS) total score = 6 during the screening and baseline assessments; 8. Traditional Chinese medicine diagnosis of liver depression and spleen deficiency; 9. Participants must have a stable and reliable caregiver, or at least be able to frequently communicate with a caregiver (at least 4 days a week for at least 2 hours per day); The caregiver will assist the patient in participating in the entire study process. The caregiver must accompany the patient to study visits and have sufficient interaction and communication with the patient to provide valuable information for rating scales such as the NPI, ADCS-ADL, MMSE, MoCA, and liver depression and spleen deficiency symptom grading scale; 10. Basic treatment for Alzheimer's disease that the patient was receiving before enrollment should remain unchanged. If the patient has been taking these medications for more than 4 weeks, the dosage should be kept stable during the study. These medications include: (1) acetylcholinesterase inhibitors: donepezil, rivastigmine, galantamine, huperzine A, and memantine; (2) glutamate receptor antagonists: memantine; 11. Patients must agree to participate in this trial, and they and their guardians must sign an informed consent form before the trial.
Exclusion criteria
Exclusion criteria: 1. Participation in other clinical trials within 30 days prior to the start of this study; 2. Pregnant or lactating women; 3. Dementia caused by other reasons: vascular dementia, central nervous system infections (such as HIV/AIDS, syphilis, etc.), Creutzfeldt-Jakob disease, Huntington's disease and Parkinson's disease, Lewy body dementia, traumatic brain dementia, other physiochemical factors (such as drug poisoning, alcohol poisoning, carbon monoxide poisoning, etc.), significant physical illnesses (such as hepatic encephalopathy, pulmonary encephalopathy, hypoxic encephalopathy, etc.), intracranial space-occupying lesions (such as subdural hematoma, communicating hydrocephalus, brain tumors), endocrine system disorders (such as thyroid disease, parathyroid disease), and dementia caused by deficiency of vitamins or other elements; 4. Previous history of neurological diseases (including stroke, optic spinal cord inflammation, Parkinson's disease, epilepsy, etc.); 5. Abnormal laboratory indicators: liver function (ALT, AST) exceeds 1.2 times the upper limit of the normal range, Cr exceeds 1.2 times the upper limit of the normal range, white blood cell count = 160 mmHg or diastolic blood pressure >= 100 mmHg; 7. Unstable or severe diseases of the heart, lungs, liver, kidney, and hematopoietic system (including unstable angina, uncontrollable asthma, active gastric bleeding, cancer, etc.); 8. Visual or hearing impairment that prevents completion of neuropsychological assessments; 9. CT or MRI scans within the past year show clinically significant focal lesions; 10. Alcohol or drug abuse; 11. Patients with mental illness, including severe depression; 12. The investigator believes that the subject cannot complete this study for any reason; 13. Subjects who are researchers or staff at the study center participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in neurological and psychiatric behavior; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in activities of daily living;Assessment of symptoms of liver depression and spleen deficiency syndrome;Improvement in cognitive ability;Improvement in intellectual status.; | — |
Countries
China
Contacts
Public ContactXu Hongxi
Shanghai University of Traditional Chinese Medicine
Outcome results
None listed