Alzheimer’s disease
Conditions
Interventions
Low Dose Group:Nasal drip of human neural stem cell preparations
Middle Dose Group:Nasal drip of human neural stem cell preparations
High Dose Group: Nasal drip of human neural stem cell preparations
Control Placebo Group:Nasal drip of normal saline
Sponsors
Shanghai Mental Health Center
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Male or postmenopausal women over 2 years,age 50-75 years (including 50 and 75 years old ); 2.In line with the 2011 National Institute on Aging and the Alzheimer's Association (nia-aa) diagnostic criteria for probable AD induced dementia; 3.Diagnostic criteria for age = 2) ; 10.Have proper visual and auditory functions,Cognitive and functional assessment can be completed; 11.Living at home ,a suitable escort can accompany the patient in all visits;Or living in a community apartment,There is a suitable escort who can accompany the patient on all visits and is free to visit the patient every week ;Patients should have stable and reliable caregivers ,Or at least be able to contact caregivers frequently (at least 4 days a week, at least 2 hours a day),Caregivers will help patients participate in the whole research process.The caregiver must accompany the patient to the study visit ,And must have full interaction and communication with patients. 12.The legal guardian agrees or the patient voluntarily participates in all examinations and assessments, all trials were completed and informed consent was signed according to the research requirements.
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 disease and Parkinson's disease, Lewy body dementia, traumatic brain disease, Other physical and chemical factors (such as drug poisoning, alcoholism, carbon monoxide poisoning, etc.), Important physical diseases (such as hepatic encephalopathy, pulmonary encephalopathy, hypoxic encephalopathy, etc.), Intracranial space occupying lesions (e.g. subdural hematoma, brain tumors), endocrine system diseases (such as thyroid diseases, parathyroid diseases) and dementia caused by vitamins or any other cause; 2.History or screening cranial MRI showed the following abnormalities: Such as cerebral hemorrhage, brain trauma, aneurysm, arteriovenous malformation, subdural hematoma, intracranial space occupying, etc.; 3.There are serious mental disorders not caused by dementia which meet the diagnostic criteria of DSM-V; 4.Accompanied by obvious physical diseases under treatment,for example, serious heart disease, serious systemic infection, severe liver and kidney dysfunction; 5.Abnormal elevation of tumor markers or history of tumor; 6.Patients with immune related diseases; 7.Nasal cavity has obvious obstruction (such as cartilage protrusion, nasal septum bending, etc.); 8.Those with serious suicide risk; 9.Patients who have participated in other clinical trials and patients who have used stem cell therapy in recent six months; 10.Other situations in which the researcher considers it inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events;Serious injury scale (SIB) score;Mini-mental state examination (MMSE) score;The clinician scores the change through an interview (cibic-plus);Neuropsychiatric questionnaire (NPI) scores;Score of the AD quality of life scale (qol-ad);Adcs-adl (adcs-adl) scores; | — |
Countries
China
Contacts
Public ContactXiao Shi-Fu
Shanghai Mental Health Center
Outcome results
None listed