Alzheimer’s disease
Conditions
Interventions
Single arm:Aducanumab iv.
Sponsors
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged between 50 and 85 years old, regardless of gender; 2. Diagnosis of AD and MCI: meet the diagnostic criteria of "mild AD" and "MCI due to AD" according to the National Institute of Gerontology of the National Institutes of Health and the Alzheimer's Disease Association (NIA-AA,2011) guideline; Aß-PET (+) (average Aßin cerebral cortex>1.15); 3. Hamilton Depression Scale (17 items) score = 6 years, able to complete neuropsychological assessment; 6. With written informed consent from both participants and their legal guardian.
Exclusion criteria
Exclusion criteria: 1. Cognitive impairment caused by other reasons, including but not limited to cerebrovascular disease, central nervous system infection, Creutzfeldt Jakob disease, Huntington's chorea and Parkinson's disease, Lewy body dementia; 2. Have suffered from neuropathy (including stroke, Neuromyelitis optica, Parkinson's disease, epilepsy, etc.); 3. With severe mental diseases diagnosed by DSM-IV criteria (including but not limited to schizophrenia, bipolar disorder, severe depression and delirium); 4. With unstable or severe disorder in heart, lung, liver, kidney and hematopoietic system or other diseases with poor prognosis (malignant tumors etc.); 5. Severe impairment in hearing or vision, which may hinder neuropsychological assessments; 6. History of serious alcohol and drug abuse within 2 years; 7. Participated in other clinical trials within 30 days before screening in this study; 8. There are contraindications for MRI, such as those with pacemakers; 9. With more than 1 hemorrhagic focus (> 1cm) or more than 4 micro-hemorrhagic foci (<1cm); application of anticoagulants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mini-Mental State Examination (MMSE);Alzheimer's Disease Rating Scale Cognitive Scale Score;Amyloid PET; | — |
Secondary
| Measure | Time frame |
|---|---|
| Activities of daily living;functional activities questionnaire; | — |
Countries
China
Contacts
Public ContactWang Gang
Ruijin Hainan Hospital
Outcome results
None listed