Aβ PET and Tau PET Imaging in the Diagnosis and Progression Assessment of Alzheimer's Disease
1 other identifier
interventional
70
0 countries
N/A
Brief Summary
This prospective study recruited 20 healthy volunteers and 50 patients diagnosed with Alzheimer's disease (AD) and mild cognitive impairment (MCI) according to clinical guidelines. Participants underwent AV45/AV-1 and AV1451 PET imaging to obtain information on Aβ protein deposition, tau protein distribution, and structural and functional information. The study aims to evaluate the value of multimodal imaging features in the diagnosis and progression assessment of AD, providing imaging evidence for novel treatment modalities such as lecanemab therapy and deep cervical vein-lymphatic anastomosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2025
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2025
CompletedFirst Posted
Study publicly available on registry
August 11, 2025
CompletedStudy Start
First participant enrolled
August 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
August 11, 2025
August 1, 2025
1.8 years
August 4, 2025
August 4, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
SUVmean
mean of standardized uptake value
1 hour from injection of the tracer
VOI
volume of interest
1 day from injection of the tracer
Study Arms (2)
normal volunteer group
EXPERIMENTALAlzheimer's disease and cognitive impairment group
EXPERIMENTALInterventions
Use PET equipment to collect multimodal imaging data. Sixty to ninety minutes after intravenous injection of 3.7 MBq/kg of 18F-AV45 or 18F-AV1, perform PET imaging in list mode to simultaneously collect structural and functional information under the same pathophysiological conditions. The next day, perform 18F-AV1451 PET imaging to obtain tau protein distribution information.
Eligibility Criteria
You may not qualify if:
- Minors, pregnant women, breastfeeding women, individuals with severe liver or kidney dysfunction, and those with a history of allergy to contrast agents or other medications; Diagnosed with viral encephalitis, acute myelitis, idiopathic epilepsy, or antibody-negative AIE; Diagnosed with any major illness; history of alcohol or drug abuse/dependence; History of cardiovascular disease, tumours, blood disorders, or poorly controlled chronic conditions; Contraindications for PET/MR imaging. History of head trauma or surgery; History of other neurological disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2025
First Posted
August 11, 2025
Study Start
August 15, 2025
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
August 11, 2025
Record last verified: 2025-08