Alzheimer's Disease
Conditions
Interventions
Gold Standard:2011 diagnostic criteria of the National Institute on Aging-Alzheimer’s Association (NIA-AA).
imaging 
of 
118F-MK6240
Sponsors
PET Center, Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Non-disease controls: (1) Between 45 and 90 years old; gender is not limited; (2) The cognitive function is determined to be normal by the researcher through cognitive tests. The CDR score is 0 points; (3) Confirmed by the researcher that there is no neurological disease, major chronic disease, malignant tumor or acute infectious disease, etc.; (4) No family history of AD, no family history of neurological diseases related to cognitive impairment and movement disorder; (5) Understand and sign a written informed consent before any assessment; (6) Female subjects must have medical records to prove that they have passed surgical sterilization (such as hysterectomy, bilateral ovarian resection, or fallopian tube ligation) or have been menopausal for more than one year; if they are still able to conceive, they must take isolated contraception during this research phase Measures. (7) Male subjects must take isolation contraceptive measures during this research phase. Male subjects are not allowed to donate sperm during this study; (8) Willing and able to cooperate with all projects of this research. 2. AD patients: (1) Between 45 and 90 years old; gender is not limited. (2) The patient meets the AD diagnostic criteria (NIA-AA 2011); (3) CDR score >=0.5 points; (4) MMSE score <=28 points; (5) Brain MRI supports the diagnosis of AD, and there is no evidence of other neurological diseases; (6) The drugs used to improve the clinical symptoms of AD must be maintained at a stable dose for more than 30 days before starting this study; (7) A written informed consent form signed by the subject or his legal guardian or caregiver; (8) If necessary, the subject can be accompanied by a nursing staff; (9) Before any assessment, the subject or his legal representative understands and signs a written informed consent; (10) Female subjects must have medical records to prove that they have passed surgical sterilization (such as hysterectomy, bilateral ovarian resection, or fallopian tube ligation) or have been menopausal for more than one year; if they are still able to conceive, they must take isolated contraception during this research phase Measures. (11) Male subjects must take isolation contraceptive measures during this research phase. Male subjects are not allowed to donate sperm during this study; (12) Willing and able to cooperate with all projects of this research.
Exclusion criteria
Exclusion criteria: 1. All subjects: (1) Suffer from serious other neurological diseases, or gastrointestinal, cardiovascular, liver, kidney, blood system, tumor, endocrine, respiratory system, immune deficiency and other serious diseases; (2) Metal devices that are not compatible with MRI have been implanted, including cardiac pacemakers, intravascular metal devices, insulin pumps, cochlear implants, nerve stimulators, cerebral aneurysm clips, etc.; (3) Cannot tolerate MRI noise or suffer from occlusion phobia; (4) In the past year, due to other clinical medical or scientific research needs, received ionizing radiation outside the scope of this experiment, so that the annual radiation exposure dose exceeded 50 mSv; (5) History of drug abuse or alcohol abuse; (6) Women during pregnancy or lactation; (7) Poor venous conditions, unable to tolerate repeated venipuncture; (8) Received experimental drug or device treatment (with unclear efficacy or safety) within 1 month; (9) Poor venous conditions, unable to tolerate repeated venipuncture; (10) May be allergic to the components of [18F]PM-PBB3 injection; (11) There is any situation that the research leader believes that any link related to this experiment may cause harm or have potential harm; 2. AD patients (1) Received drug treatment for Aß within 3 months; (2) Received medication for tau within 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PET/MR imaging;SEN, SPE, ACC, AUC of ROC; | — |
Countries
China
Contacts
Public ContactYihui Guan
Huashan Hospital Affiliated to Fudan University
Outcome results
None listed