Alzheimer's disease
Conditions
Interventions
Control group:Conventional treatment and placebo
Experimental group:Conventional treatment and anti-aging tablets
Sponsors
Affiliated Hospital of Hangzhou Normal University
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged 50 to 85 years(including 50 and 85), no gender limitation. It accords with the diagnosis of Qi and Yin deficiency in TCM; 2. Meet the diagnostic criteria for probable AD of the National Institute of Neurology, Speech Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) (1984); 3. Patients with mild or moderate disease, namely, MMSE total score: 11 <= MMSE total score <= 26 (11 <= MMSE total score <= 22 for subjects with primary school education); if the MMSE score increases or decreases by more than 2 points between baseline and screening, the investigator should review the diagnosis again to determine whether the patient is suitable for enrollment; 4. Total score of Haczynski Ischemia Scale (HIS) <= 4; 5. Total score of Hamilton Depression Scale/17-item Version (HAMD) <= 10; 6. Memory loss for at least 12 months, with a trend of progressive aggravation; 7. Neurological examination showed no obvious signs; 8. Subjects should have stable and reliable caregivers, or at least frequent contact with caregivers (at least 4 days a week, at least 2 hours a day), who will help patients participate in the entire study process. Caregivers must accompany the subjects to participate in the study visits, and must have sufficient interaction and communication with the subjects, so as to provide valuable information for the scores of CIBIC-PLUS, ADCS-ADL, NPI and other scales; 9. The subject has a primary school education or above and is capable of completing the cognitive ability and other tests stipulated in the program; 10. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Dementia caused by other causes: vascular dementia, central nervous system infection (such as HIV/AIDS, syphilis, etc.), Creutzfeldt-Jakob disease, Huntington's disease, Parkinson's disease, DLB, traumatic brain dementia, other physical and chemical factors (such as, alcoholism, drug poisoning of carbon monoxide poisoning, etc.), important body disease (such as hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial space-occupying lesions (such as a subdural hematoma, brain Tumors), diseases of the endocrine system (such as thyroid disease, parathyroid disease), and dementia caused by vitamin deficiency or any other cause; 2. Have suffered from neurological diseases (including stroke, neuromyelitis optica, Parkinson's disease, epilepsy, etc.); 3. Persons with mental illness, according to the DSM-IV criteria, including schizophrenia or other mental disorders, bipolar disorder, major depression or delirium; 4. Abnormal laboratory indicators: liver function (ALT and AST) exceeds the upper limit of the normal range by 1.5 times, Cr exceeds the upper limit of the normal range by 1.5 times, white blood cell count = 160 mmHg or = 100 mmHg or < 60 mmHg at screening time; (6) Patients with unstable or serious diseases of the heart, lung, liver, kidney or hematopoietic system (including unstable angina pectoris, uncontrollable asthma, active gastric bleeding, cancer, etc.), resting heart rate < 55 beats/min after 10 minutes of rest, and ECG abnormalities determined by researchers as unsuitable for inclusion in the group; 7. The presence of uncorrectable visual and auditory impairment and inability to complete the neuropsychological test and scale evaluation; 8. Those who are currently using and cannot stop taking drugs for Alzheimer's disease; 9. Heparin, alginate sodium and glycyrrhizate were used within 3 weeks before screening; 10. Fail to take the test drugs as prescribed, or fail to take the drugs as prescribed, or have the possibility of failing to follow the test requirements during the test; 11. Persons who abuse alcohol or drugs; 12. Pregnant or breast-feeding women; 13. Have participated in other clinical trials (excluding non-drug intervention clinical trials) within 30 days prior to the screening visit, or plan to participate in other clinical trials during the study period; 14. The researcher considers it impossible for the subject to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive function;Sleep improvement;Inflammatory factors;Changes in intestinal flora;Safety assessment; | — |
Countries
China
Contacts
Public ContactLu Xiaodong
Affiliated Hospital of Hangzhou Normal University
Outcome results
None listed