NCT02343757

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. 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. 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. 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2014

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 22, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2016

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

3.1 years

First QC Date

May 8, 2014

Last Update Submit

May 6, 2022

Conditions

DementiaAlzheimer Disease

Outcome Measures

Primary Outcomes (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.

    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 Outcomes (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.

    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

Other Outcomes (1)

  • 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)

    within one year

Study Arms (1)

PET/CT vs. PET/MRI

OTHER

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.

Device: PET/MRI

Interventions

PET/MRIDEVICE
PET/CT vs. PET/MRI

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,
  • History of adverse events related to a previous MR or PET/CT,
  • Pregnant women,
  • Minors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

DementiaAlzheimer Disease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative Diseases

Study Officials

  • James K O'Donnell, MD

    Unviversity Hospitals Case Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2014

First Posted

January 22, 2015

Study Start

October 1, 2013

Primary Completion

November 9, 2016

Study Completion

November 9, 2016

Last Updated

May 12, 2022

Record last verified: 2022-05

Locations

US(1)