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The value of synaptic vesicle protein 2A imaging in the diagnosis of Alzheimer's disease ATN system

The value of synaptic vesicle protein 2A imaging in the diagnosis of Alzheimer's disease ATN system

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100047182
Enrollment
Unknown
Registered
2021-06-10
Start date
2021-06-14
Completion date
Unknown
Last updated
2022-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's disease

Interventions

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Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Non-disease controls: (1) Aged 60 to 80 years; there is no restriction on gender; (2) The researcher's cognition is normal through the test, and the Aß imaging is negative; (3) The written informed consent must be signed by the subject or his legal guardian or caregiver; (4) Blood routine: white blood cell count (WBC) 4-10x10^9/L; platelet (PLT) 100-300x10^9/L; hemoglobin (HB) 120-160 g/L; renal function: serum creatinine is less than or equal to The upper limit of the normal range; liver function: bilirubin, AST (SGOT)/ALT (SGPT) is less than or equal to the upper limit of the normal range; ECG: no significant abnormality; (5) Willing and able to cooperate with all projects of this research. 2.AD patients: (1) The aged 60 to 80 years; there is no restriction on gender; (2) The diagnosis of AD and MCI is based on the 2011 National Aging and Alzheimer's Association (NIA-AA) diagnostic criteria for possible AD dementia and the neuropsychological method proposed by Jak and Bondi. MCI diagnosis: Two of the six neuropsychological indicators are impaired in the same cognitive domain (memory, language, or executive function) (defined as a standard deviation lower than the age-adjusted standard average> 1); memory cognition If the two tests of the domain are impaired, it is aMCI, and this study enrolled aMCI patients; (3) Brain MRI supports the diagnosis of AD, and there is no evidence of other neurological diseases; (4) A written informed consent form must be signed by the subject or his legal guardian or caregiver; (5) Blood routine: white blood cell count (WBC) 4~10x10^9/L; platelet (PLT) 100~300x10^9/L; hemoglobin (HB) 120~160 g/L; renal function: serum creatinine is less than or equal to Upper limit of normal range; Function: Bilirubin, AST(SGOT)/ALT(SGPT) is less than or equal to the upper limit of normal range; ECG: no significant abnormality; (6) Willing and able to cooperate with all projects of this research.

Exclusion criteria

Exclusion criteria: 1. Suffer from serious other neurological diseases, or gastrointestinal, cardiovascular, liver, kidney, blood system, tumor endocrine, respiratory system, immunodeficiency and other serious diseases; 2. There are contraindications for PET/CT scanning in candidate subjects. Including but not limited to elevated blood sugar that has not been effectively controlled; those who cannot accept repeated intravenous injections; those who may be allergic to drugs and their components (including a history of severe allergies or allergic reactions, especially those who are allergic to the tested drugs); Fear of confinement; 3. In the past year, in addition to participating in the expected radiation exposure of this clinical study, participated in other research programs or clinical care, so that the radiation exposure exceeded the effective dose of 50 mSv; 4. Drug abuse or alcohol abuse for at least 1 month; 5. The venous condition is poor and cannot tolerate repeated venipuncture; 6. The candidate subject has received major surgery within the past 3 months; has received experimental drug or device treatment (with unclear efficacy or safety) within 1 month; 7. The candidate subject has any clinical conditions that the research leader believes that the preparation may cause or have potential harm.

Design outcomes

Primary

MeasureTime frame
Nuclear magnetic resonance of the brain;Electrocardiogram;Hematuria routine;SEN, SPE, ACC, AUC of ROC;

Countries

China

Contacts

Public ContactGuan Yihui

Huashan Hospital, Fudan University

dljiang16@fudan.edu.cn+86 13764308300

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026