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

Recruiting
Conditions
PET/MR
Alzheimer Disease
Interventions
Device: PET/MR
Registration Number
NCT05003830
Lead Sponsor
Wuhan Union Hospital, China
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
130
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
AD groupPET/MRPatients 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 groupPET/MRAge-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.
Primary Outcome Measures
NameTimeMethod
Multi-modal PET/MR imaging mode in Alzheimer's disease2 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.2 years

Analyze the difference in 18F-PM-PBB3 deposition area and quantitative results in patients with different severity of Alzheimer's disease.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

China, Hubei Province

🇨🇳

Wuhan, Hubei, China

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