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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02343757
• Other study ID #: 12-12-13
• Status: Terminated
• Phase: N/A
• Start date: October 2013
• Est. completion date: November 9, 2016

Study information

• Verified date: May 2022
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: November 9, 2016
• Est. primary completion date: November 9, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Device:
• PET/MRI

Locations

Country	Name	City	State
United States	University Hospital Case Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	The main effect that will be evaluated in this study is the 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. Another effect that will be evaluated is if there is an added value when using 18F-florbetapir (AMYVID) in addition to 2-[F-18]-fluoro-2 deoxy-D-glucose (FDG) versus using only FDG in the evaluation of cognitive impairment patients.	within one year
Primary	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 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
Secondary	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.	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?	within one year
Secondary	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;	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)	within one year