Application of Multi-probe PET/MR Imaging in the Diagnosis and Evaluation of Alzheimer's Disease
1 other identifier
observational
130
1 country
1
Brief Summary
Alzheimer's disease (AD) is the most common cause of cognitive impairment, and its diagnosis requires a comprehensive analysis of the results of medical history, neuropsychological evaluation, imaging and laboratory tests. Among them, it has been widely recognized that amyloid PET imaging is used in the early diagnosis of AD, tau protein PET imaging is used in the assessment of the progression of AD, and the glucose metabolism PET imaging is used in the assessment of nerve damage. MRI can provide structure, blood perfusion, neural network connection damage and other information through multi-sequence scans. With the help of the PET/MR multi-modal imaging platform and multi-probe imaging technology, it can provide more sensitive and accurate imaging information for early diagnosis and disease assessment of AD, and provide a basis for clinical treatment decision-making.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2020
Typical duration for all trials
1 active site
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
Study Start
First participant enrolled
July 1, 2020
CompletedFirst Submitted
Initial submission to the registry
August 5, 2021
CompletedFirst Posted
Study publicly available on registry
August 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedFebruary 14, 2023
February 1, 2023
3.2 years
August 5, 2021
February 13, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Multi-modal PET/MR imaging mode in Alzheimer's disease
Subjects with suspected or confirmed Alzheimer's disease who have completed multi-modal multi-probe PET/MR imaging, compare with healthy control group to determine the image mode of AD.
2 years
Correlation between the results of 18F-PM-PBB3 PET/MR imaging and Alzheimer's disease progression.
Analyze the difference in 18F-PM-PBB3 deposition area and quantitative results in patients with different severity of Alzheimer's disease.
2 years
Study Arms (2)
AD group
Patients who meet the core clinical diagnostic criteria for Alzheimer's disease as defined by NIA-AA for mild cognitive decline or probable Alzheimer's disease.
Healthy control group
Age-matched subjects, who are healthy and have no clinically significant related abnormalities in their physical examinations, laboratory tests, vital signs, or ECG. In addition, no first-degree family history of early-onset AD or other neurodegenerative diseases related to dementia.
Interventions
18F-FDG, 11C-PIB and 18F-PM-PBB3 injection are radiopharmaceuticals used for positron emission tomography (PET) imaging. 18F-FDG dose is about 3.7-5.4 MBq/kg (0.1 -0.15 mCi/kg), and used in the assessment of brain glucose metabolism. 11C-PIB dose is about 5-10mCi, and used in the assessment of amyloid deposition. 18F-PM-PBB3 dose is about 5-10mCi, and used in the assessment of tau deposition. Use PET/MR equipment for simultaneous PET and MR collection.
Eligibility Criteria
Central China
You may qualify if:
- Patients who meet the core clinical diagnostic criteria for Alzheimer's disease as defined by NIA-AA for mild cognitive decline or probable Alzheimer's disease.
- Subjects are able to understand and sign the informed consent voluntarily, with good compliance.
You may not qualify if:
- Have contraindications to PET/MR examination.
- Clinically clear history of stroke.
- Have a history of bipolar disorder or depression.
- Patients with severe heart, liver, and kidney dysfunction.
- Pregnant or lactating women.
- Patients refuse to sign the informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China, Hubei Province
Wuhan, Hubei, 430022, China
Related Publications (1)
Xu X, Ruan W, Liu F, Liu Q, Gai Y, Su Y, Liang Z, Sun X, Lan X. Characterizing Early-Onset Alzheimer Disease Using Multiprobe PET/MRI: An AT(N) Framework-Based Study. Clin Nucl Med. 2023 Jun 1;48(6):474-482. doi: 10.1097/RLU.0000000000004663. Epub 2023 Apr 24.
PMID: 37075301DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Xiaoli Lan, MD,PhD
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Department of nuclear medicine
Study Record Dates
First Submitted
August 5, 2021
First Posted
August 12, 2021
Study Start
July 1, 2020
Primary Completion
September 1, 2023
Study Completion
September 1, 2023
Last Updated
February 14, 2023
Record last verified: 2023-02