Clinical trial NCT02343757: Alzheimer's Disease Imaging With PET/MRI - Beta-amyloid
Official title: Alzheimer's Disease Imaging With PET/MRI - Beta-amyloid
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dementia
Alzheimer Disease
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2015-01-22
Enrollment: 4
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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


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,
* Minors.

Primary outcomes:
measure: 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.
timeFrame: within one year
Secondary outcomes:
measure: 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.
timeFrame: within one year
measure: 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;
timeFrame: within one year
Other outcomes:
measure: Measurement of Effect (ability of 18F-florbetapir (AMYVID) PET/MRI to assess the diagnosis of a patient, compared to both PET/CT and the diagnosis from the clinical record)
timeFrame: within one year
Locations:
city: Cleveland
country: United States
facility: University Hospital Case Medical Center
state: Ohio
Study officials:
affiliation: Unviversity Hospitals Case Medical Center
name: James K O'Donnell, MD
role: PRINCIPAL_INVESTIGATOR
References: