Alzheimer’s disease Nervous System Diseases
Conditions
Interventions
In this study, a treatment called t04 was given to patients with Alzheimers disease. The treatment was given by clinical doctors or nursing staff with more than 5 years of experience and was administe
Sponsors
Talengen Institute of Life Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent/assent obtained prior to any assessment performed 2. Age 50 to 100 years old (including 50 and 100 years old), male or female 3. Meet the diagnostic criteria of "likely ad dementia" of the National Institute on aging Alzheimer's disease association (NIA-AA) (2011) 4. The subjects are primary school graduates/graduates and above, and have the ability to complete the cognitive ability test and other tests specified in the program 5. Memory loss lasted for at least 6 months and tended to worsen gradually 6. Subjects with mild or moderate illness: 0 = total score of MMSE = 26 7. Total score of Clinical Dementia Rating Scale (CDR): Mild dementia: CDR = 1.0; Moderate dementia: CDR = 2.0
Exclusion criteria
Exclusion criteria: 1. Dementia caused by other reasons: vascular dementia, central nervous system infection, Creutzfeldt Jakob disease, Huntington's disease, Parkinson's disease, Lewy body dementia, traumatic dementia, other physical and chemical factors (such as drug poisoning, alcoholism, carbon monoxide poisoning, etc.), important physical diseases (such as hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial space occupying lesions (such as subdural hematoma, brain tumor), endocrine disorders (such as thyroid disease, parathyroid disease), and vitamin B12, folic acid deficiency or any other known cause; 2. Have suffered from central nervous system diseases (including stroke, optic neuromyelitis, epilepsy, etc.); 3. Subjects who were diagnosed with psychiatric disorders according to DSM-V criteria, including schizophrenia or other mental diseases, bipolar disorder, severe depression or delirium; 4. Abnormal laboratory indexes: liver function (ALT and AST) exceeded 1.5×ULN, renal function (CR) exceeded 1.5×ULN, and creatine kinase exceeded 2×ULN; 5. Untreated hypertensive and hypotensive subjects at screening, or hypertensive subjects with uncontrolled hypertension after treatment; subjects with good blood pressure control after treatment can be determined by the investigator to be suitable for inclusion in this study; 6. Within 1 month of the screening visit, the subject has new or ongoing unstable or serious heart, lung, liver, kidney and hematopoietic diseases according to the judgment of the researcher, and does not meet the conditions for clinical research; 7. Clinically, people with significant allergic reaction history, especially drug allergy history, or known allergy to this product and its excipients; 8. Dyspepsia, esophageal reflux, gastric bleeding or peptic ulcer disease, frequent heartburn (= once a week) or any surgical operation that may affect drug absorption (such as partial/total gastrectomy, partial/total small bowel resection and cholecystectomy) within 6 months before screening 9. Alcohol or drug abusers 10. Human immunodeficiency virus antibody (ant HIV) and Treponema pallidum antibody (ant TP) are positive 11. Those who are currently using and cannot stop using drugs for Alzheimer's disease 12. Female subjects with positive pregnancy test or lactation and subjects unable to take effective contraceptive measures or have family planning 13. Participated in other clinical trials within 3 months before the screening visit 14. There are other situations that the researcher believes are not suitable for participation in this study
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Adverse events measured using blood routine tests, blood biochemistry, coagulation function, hemolysis function, routine urine test, 12 lead ECG, physical examination, and vital signs, etc at baseline and 22 and 46 weeks | — |
Primary
| Measure | Time frame |
|---|---|
| Memory function measured using the Minimum Mental State Examination (MMSE) test at baseline and 2, 6, 10, 22 and 46 weeks | — |
Countries
China
Contacts
Public ContactChunying Guo
Outcome results
None listed