Cleveland, Ohio 44106


Purpose:

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


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, - Minors.


NCT ID:

NCT02343757


Primary Contact:

Principal Investigator
James K O'Donnell, MD
Unviversity Hospitals Case Medical Center

James K O'Donnell, MD
Phone: (216)844-3319
Email: Jamesk.ODonnell@UHhospitals.org


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44106
United States

James K O'Donnell, MD
Phone: 216-844-3319

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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