Establishment of the Chinese Preclinical Alzheimer's Disease Study With Multiple Neuroimaging
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-90
SponsorHuashan Hospital
About this trial
The goal of this observational study is to investigate neuroimage and biomarkers in the Alzheimer's continuum in Chinese population. We aimed to:
* To reveal the progress of AD by multiple neuroimage and biomarkers; * To reveal the longitudinal change of biomarkers and cognition of AD in Chinese population; * To investigate the interaction of markers between body and brain; * To set up new markers by neuroimage.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged between 45 and 90 years; no gender restrictions;
CDR score ≥ 0.5;
MMSE score ≤ 24;
Brain MRI findings support the diagnosis of AD, with no evidence of other neurological diseases;
Disqualifiers
Presence of severe neurological diseases or serious disorders affecting the gastrointestinal, cardiovascular, hepatic, renal, hematologic, oncologic, endocrine, respiratory, or immune systems;
Presence of MRI-incompatible metal implants, including cardiac pacemakers, intravascular metal devices, insulin pumps, cochlear implants, nerve stimulators, or cerebral aneurysm clips;
Inability to tolerate MRI noise or a history of claustrophobia;
Exposure to ionizing radiation exceeding 50 mSv within the past year due to participation in other clinical or scientific research;
Trial population
Participants are recruited from neurology outpatient clinics and community settings.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No Intervention: Observational Cohort
Other interventionNo intervention
Treatment groups
3,000 Participants
are divided into 1 treatment groupGroup A: Chinese Preclinical Alzheimer's Disease Study1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
90 minutes post-injection2
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.
Time frame
90 minutes post-injectionSecondary outcomes
1
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.
Time frame
A 5-year follow-up with assessments conducted annually.2
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.
Time frame
A 5-year follow-up with assessments conducted annually.3
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.
Time frame
A 5-year follow-up with assessments conducted annually.Sponsors and contacts
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Source ClinicalTrials.gov