Alzheimer’s Disease
Conditions
Interventions
Gold Standard:The National Institute on Aging—Alzheimer’s Association Framework on Alzheimer’s disease: Application to clinical trials(J. Cummings / Alzheimer’s & Dementia 15 (2019) 172-178).
Index test:AD-related 
value 
Clinical 
assessment 
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
55 Years to 75 Years
Inclusion criteria
Inclusion criteria: Alzheimer's disease: AD diagnostic criteria proposed by the national institute of aging and alzheimer's association joint working group in 2011; Mild cognitive impairment: Petersen diagnostic criteria in 2001; Non-disease control: 1.Age and gender were matched with the above disease groups; 2. No chief complaint or objective evidence of neurological diseases.
Exclusion criteria
Exclusion criteria: (1) contraindications of MRI and/or PET scans were present in the candidate subjects. Including but not limited to implanted metal devices including pacemakers, intravascular metal devices, insulin pumps, nerve stimulation devices, etc.; Uncontrolled hyperglycemia; Pregnant, nursing or lactating women; Unable to receive repeated intravenous injections; Persons who may be allergic to the drugs and their components (including a history of severe allergies or allergic reactions, especially to the tested drugs); Hermetic phobia. (2) during the past year, in addition to participating in the expected radiation exposure of this clinical study, participated in other study protocols or clinical care, resulting in radiation exposure exceeding the effective dose of 50 mSv. (3) the candidate subjects had the following uncontrollable clinical conditions: including but not limited to systemic diseases including coronary artery disease, heart failure, unstable angina or arrhythmia, uremia, liver failure, sudden stroke, acute myocardial infarction, and unstable diabetes. Had received head injury, intracranial surgery; Hypoxia, sepsis or severe infectious diseases; Mental disorders, epilepsy and major depression or a history of them; History of human immunodeficiency virus (HIV) positive testing. (4) the candidate subject underwent major surgery within the last three months. There is a significant abnormality in laboratory examination, which is clinically considered to be significant or unstable. Life expectancy is less than one year. (5) drug or alcohol abuse for at least 3 months. (6) the candidate subject has any clinical condition that the study host considers to be likely to cause or potentially harmful.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AD-related pattern expression; | — |
Secondary
| Measure | Time frame |
|---|---|
| standard uptake value ratio;Clinical cognitive assessment scale; | — |
Countries
China
Contacts
Public ContactChuantao Zuo
PET Center, Huashan Hospital, Fudan University
Outcome results
None listed