Application of Multi-probe PET/MR Imaging in the Diagnosis and Evaluation of Alzheimer's Disease
February 13, 2023 updated by: Xiaoli Lan, Wuhan Union Hospital, China
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.
Study Overview
Detailed Description
Cognitive impairment is a common neurodegenerative disease.
The incidence of Alzheimer's disease (AD) in people over 65 years old is close to 5%, which brings a heavy burden to society.
Relying only on medical history and neuropsychological evaluation, the early diagnosis and differential diagnosis of AD are difficult, and further imaging and laboratory tests are needed.
This project will use PET/MRI, the most advanced imaging platform, to design a prospective clinical research program, combined with multi-sequence MRI and multi-probe PET imaging, to evaluate suspected or diagnosed AD patients.
Through multi-parameter analysis of the structure MRI, function MRI (3D ASL, BOLD, DTI), metabolism PET (18F-FDG) , Aβ (11C-PIB) and tau (18F-PM-PBB3) PET, combined with clinical information, to evaluate the value of multi-modal imaging for early diagnosis and differential diagnosis of AD, to assist the clinic in the adjustment of early intervention measures and treatment strategies.
Study Type
Observational
Enrollment (Anticipated)
130
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Hubei
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Wuhan, Hubei, China, 430022
- Recruiting
- China, Hubei Province
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Central China
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
Other Names:
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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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Multi-modal PET/MR imaging mode in Alzheimer's disease
Time Frame: 2 years
|
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
|
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Correlation between the results of 18F-PM-PBB3 PET/MR imaging and Alzheimer's disease progression.
Time Frame: 2 years
|
Analyze the difference in 18F-PM-PBB3 deposition area and quantitative results in patients with different severity of Alzheimer's disease.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 1, 2020
Primary Completion (ANTICIPATED)
September 1, 2023
Study Completion (ANTICIPATED)
September 1, 2023
Study Registration Dates
First Submitted
August 5, 2021
First Submitted That Met QC Criteria
August 5, 2021
First Posted (ACTUAL)
August 12, 2021
Study Record Updates
Last Update Posted (ESTIMATE)
February 14, 2023
Last Update Submitted That Met QC Criteria
February 13, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XLan-S1208
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.