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The goal of this observational study is to investigate neuroimage and biomarkers in the Alzheimer's continuum in Chinese population. We aimed to:
The observational study is recruiting participants from clinics and communities with cognitive impairments and un-impairments. As the part of our previous study: Chinese Preclinical Alzheimer's Disease Study (C-PAS) cohort. We will include lager size of body and brain PET imaging. The study will also integrate multi-dimensional scales, peripheral biomarkers, metabolites, electroencephalograms, genetics, and other indicators for multi-omics analysis to deeply explore the mechanisms underlying the onset and progression of Alzheimer's disease. By identifying risk factors closely associated with Alzheimer's disease, we aim to develop a comprehensive disease risk model, providing reliable evidence for early detection and prevention, and uncovering new targets for therapeutic interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chinese Preclinical Alzheimer's Disease Study | This cohort will included AD, MCI and Cognitively un-impairments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention: Observational Cohort | Other | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Synaptic Density in Alzheimer's Disease Using Synaptic Vesicle Glycoprotein 2A (SV2A) PET Tracer [¹⁸F]SDM-8 | Subjects received an intravenous injection of the radiopharmaceutical at a dose of 1.8 MBq/kg (0.05 mCi/kg). After a 90-minute rest in a quiet, light-controlled room, PET imaging was performed using a PET/CT or PET/MRI scanner with a dedicated head protocol. Scanning was conducted in 3D mode (FOV: 180 mm), and images were reconstructed using the 3D RAMLA algorithm at a resolution of 2×2×2 mm. PET images were co-registered with structural CT or MRI scans. For quantitative analysis, target regions, including cortical areas and the cerebellum, were delineated on normalized structural images and projected onto PET images to measure radiotracer uptake. The standardized uptake value ratio (SUVr) was calculated as the ratio of cortical to cerebellar uptake. | 90 minutes post-injection |
| Evaluation of Neuronal Function in Alzheimer's Disease Using Metabotropic Glutamate Receptor 5 (mGluR5) PET Tracer [¹⁸F]PS232 | Subjects received an intravenous injection of the radiopharmaceutical at a dose of 1.8 MBq/kg (0.05 mCi/kg). After a 90-minute rest in a quiet, light-controlled room, PET imaging was performed using a PET/CT or PET/MRI scanner with a dedicated head protocol. Scanning was conducted in 3D mode (FOV: 180 mm), and images were reconstructed using the 3D RAMLA algorithm at a resolution of 2×2×2 mm. PET images were co-registered with structural CT or MRI scans. For quantitative analysis, target regions, including cortical areas and the cerebellum, were delineated on normalized structural images and projected onto PET images to measure radiotracer uptake. The standardized uptake value ratio (SUVr) was calculated as the ratio of cortical to cerebellar uptake. | 90 minutes post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| Multi-sequence MR Imaging Data Collection | This multi-sequence MRI approach allows for the early detection of neurodegenerative changes, tracking of synaptic and vascular alterations, and identification of atrophy patterns associated with cognitive decline. Each subject underwent MRI scanning using a Siemens Prisma 3.0T research MRI scanner. The acquisition sequences included T1WI, T2WI, DTI, ASL, SWI, and rs-fMRI, which provide comprehensive structural, functional, and perfusion-related information on brain integrity. These sequences were also collected during follow-up assessments. |
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Inclusion Criteria:
(1) Aged between 45 and 90 years; no gender restrictions; (2) Cognitive function is assessed as normal by the researcher based on cognitive tests, with a Clinical Dementia Rating (CDR) score of 0; (3) Confirmed by the researcher to have no neurological diseases, major chronic illnesses, malignant tumors, or acute infectious diseases; (4) No family history of Alzheimer's disease (AD) or other neurological diseases related to cognitive impairment and movement disorders; (5) Able to understand and provide written informed consent before any assessment; (6) Female subjects must provide medical documentation proving they have undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) or have been menopausal for over one year. If they are still of childbearing potential, they must use effective contraceptive measures during the study; (7) Male subjects must use effective contraceptive measures during the study period and are prohibited from donating sperm during this time; (8) Willing and able to comply with all study procedures. 2. Cognitive impaired(CI) patients:
Exclusion Criteria:
All subjects:
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Participants are recruited from neurology outpatient clinics and community settings.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yihui Guan, MD | Contact | +8613764308300 | +86 | guanyihui@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Fang Xie, PhD | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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DNA from Blood will be collected
| A 5-year follow-up with assessments conducted annually. |
| Peripheral Blood Biomarker Collection | Blood-based biomarkers offer a minimally invasive method for detecting Alzheimer's disease-related pathology and monitoring disease progression , including tau pathology, neuroinflammation, and glial activation. Peripheral blood biomarker data, including p-tau181, p-tau231, p-tau217, GFAP, sTREM2, etc., were collected to assess neurodegeneration and neuroinflammation. Plasma samples were stored at -80 °C and analyzed using the Quanterix Simoa HD-1 platform. Measurements were conducted by technicians blinded to clinical imaging data. The concentrations of these plasma biomarkers are presented in pg/mL. | A 5-year follow-up with assessments conducted annually. |
| Neuropsychological Scale Assessment | Neuropsychological assessments provide crucial insights into cognitive decline, aiding in the early diagnosis of Alzheimer's disease and other dementias. Cognitive function was assessed using standardized neuropsychological scales, including MMSE (minimum value 0, maximum value 30, higher scores indicate better cognitive function) and MoCA-B (minimum value 0, maximum value 30, higher scores indicate better cognitive function), among others. | A 5-year follow-up with assessments conducted annually. |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |