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Clinical Trials/NCT05003830
NCT05003830
Recruiting
Not Applicable

Application of Multi-probe PET/MR Imaging in the Diagnosis and Evaluation of Alzheimer's Disease

Wuhan Union Hospital, China1 site in 1 country130 target enrollmentJuly 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
Wuhan Union Hospital, China
Enrollment
130
Locations
1
Primary Endpoint
Multi-modal PET/MR imaging mode in Alzheimer's disease
Status
Recruiting
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2020
End Date
September 1, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Wuhan Union Hospital, China
Responsible Party
Principal Investigator
Principal Investigator

Xiaoli Lan

Director of the Department of nuclear medicine

Wuhan Union Hospital, China

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

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.

Study Sites (1)

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