Phase
Condition
N/ATreatment
N/AClinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subjects themselves and their legal representatives (or their immediate familymembers) voluntarily received the treatment and signed the consent form before thisstudy;
- Age ≧ 50 years, males and females;
- Subjects diagnosed with Patients with mild or moderate Alzheimer's disease, based onthe NIA/AA(2011).
- The Mini-Mental Status Examination (MMSE) score was 10-24 (inclusive);
- Modified Hachinski Ischemic Scale (MHIS) score was ≦ 4;
- Suspension of cognitive-enhancing drugs and marketed therapeutic drugs such as ginkgo,high-dose vitamin E, lecithin, estrogen, non-steroidal anti-inflammatory drugs (NSAIDs), Donepezil, Memantine, etc ;
- Based on medical history, physical examination, vital signs, laboratory tests and 12-lead electrocardiogram (ECG) results, subjects are generally in good condition;
- Subjects can walk independently or receive outpatient follow-up with assistive devices (wheelchairs, walkers or crutches), while the subject's vision and hearing (allowingglasses and / or hearing aids) do not affect the follow-up procedure;
- The subject has an identified and reliable caregiver who must also meet the followingconditions:
(1) In the hospital, caregiver can independently read and understand relevant researchdocuments, and can do necessary communication with the investigator; (2) Caregiver canfollow clinical research procedures and ensure that accurate information about the statusof the subject can be provided during the study; (3) Caregiver live with the subject; ortake care of the subject no less than 3 days a week and no less than 2 hours a day; 10.Female subjects with fertility (including women of childbearing age and women less than 1year after menopause) were required to take effective contraception throughout the study.At the same time, urine pregnancy tests were negative during screening.
Exclusion
Exclusion Criteria:
- The subjects with more serious allergic constitution;
- Received allogeneic mesenchymal progenitor cell therapy or its derived exosomes;
- Laboratory test (any item meets): neutrophil absolute number < 1.0 × 109 / L, plateletcount < 100 × 109 / L, serum albumin < 30g / L, serum creatinine > upper limit ofnormal value range, total bilirubin, alanine aminotransferase, aspartateaminotransferase > upper limit of 2 times of normal value range;
- The subject has serious and poorly controlled concomitant diseases, such as (but notlimited to) cardiovascular, cerebrovascular, liver, kidney, lung, endocrine and othersystem diseases;
- Severe Alzheimer's Disease;
- Severe depression;
- The subjects suffered from Parkinson's disease, multiple cerebral infarction, vasculardementia, Huntington's disease, hydrocephalus, progressive supranuclear paralysis,multiple sclerosis, epilepsy, mental retardation or major history of brain injury (with or without persistent neurological impairment) or known brain structuralabnormalities;
- The subject has an history malignant tumor;
- The subject has severe generalized infectious diseases in the 3 months prior to thistrial.;
- The subject has contraindication of MRI, included but not only: the subject installedheart pacemaker, defibrillator, heart bracket, heart valve prosthesis, metal clipafter aneurysm surgery, drug infusion device implanted in vivo, any electronic deviceimplanted in the body (nerve stimulator, bone growth stimulator) endovascular coil,strainer, ECG monitor, metal suture, shrapnel or sand of body, plate fixation andsteel nail after fracture surgery, artificial cochlea, middle ear shift plant,metallic intraocular foreign body etc; the subject is a claustrophobia, critical illpatient and so on.
- The subject tests positive for: HIV, HBV, HCV and treponema pallidum;
- The subject has history of alcoholism, drug abuse, or mental illness in the 10 yearsprior to this trial.
- The subject has participated in any other clinical trial in the 6 months prior to thistrial;
- The female subjects are pregnant, lactating or pregnant in the past half a year;
- The subject has any other unsuitable condition (such as factors reducing the follow-upcompliance) to be determined by the investigator.
Study Design
Study Description
Connect with a study center
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai 200000
ChinaActive - Recruiting

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