Alzheimer's Disease Imaging With PET/MRI - Beta-amyloid

Not Applicable

Terminated

• Conditions: Alzheimer Disease; Dementia
• Interventions: Device: PET/MRI

• Registration Number: NCT02343757
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary

The early detection of a preclinical AD or early stage of AD with amyloid imaging could improve the diagnosis and provide knowledge for better therapeutical approach by combining the best of imaging: structural MR sequences and newly FDA-approved biomarker for amyloid PET imaging, all these two techniques with their strengths in one machine.

Specific Aims and Hypotheses can be summarized as follows:

1. To assess image quality and diagnostic performance of 18F-florbetapir (AMYVID) PET/MRI, including direct comparison to corresponding PET/CT images of the same patients.

2. To evaluate the incremental value of using 18F-florbetapir (AMYVID) in addition to 2-\[F-18\]-fluoro-2 deoxy-D-glucose (FDG) versus FDG alone. Does quantification of plaque burden correlate with degree of neuronal degeneration as depicted by FDG as well as with clinical severity?

3. To determine plaque burden quantitatively with 18F-florbetapir (AMYVID) in PET (form PET/CT and from PET/MR) using novel software developed specifically for these brain application; Computer-Aid Diagnosis for Dementia for amyloid imaging - CAD4D-amyloid

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-05-08
• Study First Submitted QC: 2015-01-21
• Study First Posted: 2015-01-22
• Primary Completion: 2016-11-09
• Study Completion: 2016-11-09
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Patients with suspected AD, MCI and other cognitive impairment will be referred by their neurologist to have a clinical ordered FDG-PET/CT and clinically indicated AMYVID in addition,
• Patients equal to or greater than 21 years old,
• Signed informed consent by patient or legal guardian,
• Physically capable to cooperate.

Exclusion Criteria

• Subjects who do not meet the above mentioned inclusion criteria,
• Subjects unwilling or unable to sign the informed consent form,
• Subjects with any significant psychiatric or neurologic disorder or disease other than dementia expected to interfere with the study,
• Subjects unable to undergo MR scanning due to exclusion via UHCMC MR restrictions (e.g. certain implanted metallic or electronic devices),
• History of adverse events related to a previous MR or PET/CT,
• Pregnant women,
• Minors.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET/CT vs. PET/MRI	PET/MRI	Patients will be included if presenting with the clinical suspicious of AD, Mild Cognitive Impairment (MCI) or other cognitive impairment to be further determined. Patients will undergo two doubles scans in two steps with a maximum of 2 week between both: the first step will be one day double scan with FDG imaged by PET-CT and PET-MRI; and the second step will be one day double scan with 18F-florbetapir imaged by PET-CT and PET-MRI at a different timepoints as shown in figure 1.

Primary Outcome Measures

Name	Time	Method
To assess image quality and diagnostic performance of 18F-florbetapir (AMYVID) PET/MRI, including direct comparison to corresponding PET/CT images of the same patients.	within one year	To assess image quality and diagnostic performance of 18F-florbetapir (AMYVID) PET/MRI, including direct comparison to corresponding PET/CT images of the same patients.

Secondary Outcome Measures

Name	Time	Method
To evaluate the incremental value of using 18F-florbetapir (AMYVID) in addition to 2-[F-18]-fluoro-2 deoxy-D-glucose (FDG) versus FDG alone.	within one year	2. To evaluate the incremental value of using 18F-florbetapir (AMYVID) in addition to 2-\[F-18\]-fluoro-2 deoxy-D-glucose (FDG) versus FDG alone. Does quantification of plaque burden correlate with degree of neuronal degeneration as depicted by FDG as well as with clinical severity?
To determine plaque burden quantitatively with 18F-florbetapir (AMYVID) in PET (form PET/CT and from PET/MR) using novel software developed specifically for these brain application;	within one year	3. To determine plaque burden quantitatively with 18F-florbetapir (AMYVID) in PET (form PET/CT and from PET/MR) using novel software developed specifically for these brain application; Computer-Aid Diagnosis for Dementia for amyloid imaging - CAD4D-amyloid (Philips Research, Hamburg)

Trial Locations

Locations (1)

University Hospital Case Medical Center; 🇺🇸 Cleveland, Ohio, United States