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

NCT ID: NCT05003830

Last Updated: 2023-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2023-09-01

Brief Summary

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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

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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.

Conditions

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Alzheimer Disease PET/MR

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

PET/MR

Intervention Type DEVICE

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.

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.

PET/MR

Intervention Type DEVICE

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.

Interventions

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PET/MR

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.

Intervention Type DEVICE

Other Intervention Names

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Positron Emission Tomography/Magnetic Resonance

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Xiaoli Lan

Director of the Department of nuclear medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaoli Lan, MD,PhD

Role: STUDY_CHAIR

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Locations

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China, Hubei Province

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoli Lan, MD, PhD

Role: CONTACT

+86-13886193262

Xun Sun, PhD

Role: CONTACT

+86-13871349651

Facility Contacts

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Xiaoli Lan

Role: primary

+86-13886193262

References

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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.

Reference Type DERIVED
PMID: 37075301 (View on PubMed)

Other Identifiers

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XLan-S1208

Identifier Type: -

Identifier Source: org_study_id

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