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

February 13, 2023 updated by: Xiaoli Lan, Wuhan Union Hospital, China
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • China, Hubei Province

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Central China

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
Other Names:
  • Positron Emission Tomography/Magnetic Resonance
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.
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.
Other Names:
  • Positron Emission Tomography/Magnetic Resonance

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wuhan Union Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2021

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XLan-S1208

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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