?????? ?????? Alzheimer disease
Conditions
Interventions
???? Low dose group:Transnasal instillation of human neural stem cells
Medium dose group:Transnasal instillation of human neural stem cells
High dose group:Transnasal instillation of human neural stem cells
control group:Intranasal infusion of human neural stem cells placebo
Sponsors
Shanghai Oriental Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or postmenopausal female, aged 50-75 years; 2. It meets the diagnostic criteria of Alzheimer's disease association (NIA-AA) and National Institute of aging (2011); 3. MMSE 10-20; 4. The subjects are those who have completed primary school or above and are able to complete the cognitive ability test and its test specified in the program; 5. Rosen improved Hachinski ischemic scale score =2 points); 8. Language fluency and evidence of normal intelligence before onset; 9. With appropriate visual and auditory functions, cognitive and functional assessment can be completed; 10. Living at home, with appropriate care can accompany the patient for all visits; or living in a community apartment, with appropriate care can accompany the patient for all visits and visit the patient freely every week; the patient should have a stable and reliable caregiver, or at least be able to contact the caregiver frequently (at least 4 days a week, at least 2 hours a day), the caregiver will help Help patients to participate in the whole process of the study. The caregiver must accompany the patient to participate in the study visit, and have sufficient interaction and communication with the patient, so as to provide valuable information for NPI, adcs-adl, Cibic plus and other scales; 11. Patients voluntarily participate in all examinations and assessments, complete all trials as required by the study and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Dementia caused by other causes: vascular dementia, central nervous system infection (such as AIDS, syphilis, etc.), Creutzfeldt Jakob disease, Huntington's and Parkinson's disease, dementia due to Lewy body, dementia due to brain injury, other physical and chemical factors (such as drug poisoning, alcoholism, carbon monoxide poisoning, etc.), important physical diseases (such as hepatic encephalopathy, pulmonary encephalopathy, hypoxia, etc.) Sexual encephalopathy, etc.), intracranial space occupying lesions (such as subdural hematoma, brain tumor), endocrine system lesions (such as thyroid disease, parathyroid disease), and dementia caused by vitamins or any other reasons; 2. History or MRI examination showed the following abnormalities: cerebral hemorrhage, brain injury, aneurysm, arteriovenous malformation, subdural hematoma, intracranial space occupation, etc; 3. There are serious mental disorders or symptoms in clinic; 4. Accompanied by obvious in the treatment of physical diseases, such as serious heart disease, serious systemic infection, serious liver and kidney dysfunction; 5. Abnormal elevation of tumor markers or history of tumor; 6. The nasal cavity has obvious obstruction (such as cartilage protruding, nasal septum bending, etc.); 7. Those with serious suicide risk; 8. If you take ACEI or memantine, take it continuously for less than 4 months and maintain a stable dose less than 2 months before entering the group; 9. Patients who participated in other clinical trials and who had used stem cell therapy in the past half a year; 10. Other situations that the researchers think are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADAS-cog score;ADL score; | — |
Secondary
| Measure | Time frame |
|---|---|
| CIBIC-plus score;NPI score;QOL-AD score; | — |
Countries
China
Contacts
Public ContactWu Jing-Wen
Shanghai Oriental Hospital
Outcome results
None listed