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

H

Huazhong University of Science and Technology

Status

Enrolling

Conditions

Alzheimer Disease
PET/MR

Treatments

Device: PET/MR

Study type

Observational

Funder types

Other

Identifiers

NCT05003830
XLan-S1208

Details and patient eligibility

About

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.

Full 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.

Enrollment

130 estimated patients

Sex

All

Ages

50 to 85 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

130 participants in 2 patient groups

AD group
Description:
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.
Treatment:
Device: PET/MR
Healthy control group
Description:
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.
Treatment:
Device: PET/MR

Trial contacts and locations

1

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Central trial contact

Xiaoli Lan, MD, PhD; Xun Sun, PhD

Data sourced from clinicaltrials.gov

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