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

University Hospitals Cleveland Medical Center1 site in 1 country4 target enrollmentOctober 2013

ConditionsDementia Alzheimer Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dementia
Sponsor: University Hospitals Cleveland Medical Center
Enrollment: 4
Locations: 1
Primary Endpoint: 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.
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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:

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.
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; Computer-Aid Diagnosis for Dementia for amyloid imaging - CAD4D-amyloid

Registry

clinicaltrials.gov

Start Date

October 2013

End Date

November 9, 2016

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Hospitals Cleveland Medical Center

Responsible Party

Sponsor

Eligibility Criteria

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,

Outcomes

Primary Outcomes

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.

Time Frame: 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 Outcomes

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)
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)