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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05003830
• Other study ID #: XLan-S1208
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: September 1, 2023

Study information

• Verified date: February 2023
• Source: Wuhan Union Hospital, China
• Contact: Xiaoli Lan, MD, PhD
• Phone: +86-13886193262
• Email: lxl730724[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• PET/MR

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	China, Hubei Province	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multi-modal PET/MR imaging mode in Alzheimer's disease	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
Primary	Correlation between the results of 18F-PM-PBB3 PET/MR imaging and Alzheimer's disease progression.	Analyze the difference in 18F-PM-PBB3 deposition area and quantitative results in patients with different severity of Alzheimer's disease.	2 years