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Evaluation of Inter-reader Reliability Using Images From Subjects With Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI)

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
florbetapir F 18
Sponsored by
Avid Radiopharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease focused on measuring Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Participants:

  • Inclusion Criteria AD:

    • Male or female >=50 years of age
    • Meet National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) criteria for probable AD with Mini-Mental State Examination (MMSE) score of 10-24

  • Inclusion Criteria MCI:

    • Male or female >=50 years of age
    • Have a Clinical Dementia Rating (CDR) of 0.5
    • MMSE >24

  • Exclusion Criteria:

    • Have a history or current diagnosis of other neurologic disease
    • Have had or currently have a diagnosis of other neurodegenerative disease
    • Have participated in experimental therapy targeted to amyloid plaque

Readers:

•Private nuclear medicine physicians with no prior training in reading florbetapir-PET scans

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Independent, blinded reader trainees

    Arm Description

    Seven practicing nuclear medicine physicians with no prior training in reading scans from florbetapir-PET, or other amyloid imaging agents.

    Outcomes

    Primary Outcome Measures

    Inter-reader Agreement - Median Kappa Statistic
    Seven readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Simple kappa statistics were calculated for each reader versus the other 6 readers. Primary outcome measure was the median kappa of each reader versus the other 6 readers.

    Secondary Outcome Measures

    Overall Inter-reader Agreement - Fleiss' Kappa
    Seven readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Fleiss' kappa was calculated across all inter-reader comparisons.

    Full Information

    First Posted
    March 26, 2012
    Last Updated
    July 18, 2022
    Sponsor
    Avid Radiopharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01565382
    Brief Title
    Evaluation of Inter-reader Reliability Using Images From Subjects With Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI)
    Official Title
    Evaluation of Physician Training for Interpretation of Florbetapir-PET Scans: Evaluation of Inter-reader Reliability Using Images From Subjects With a Clinical Presentation of AD or MCI
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2011 (undefined)
    Primary Completion Date
    February 2011 (Actual)
    Study Completion Date
    February 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Avid Radiopharmaceuticals

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Re-read of brain amyloid scans acquired in previous AV-45 clinical studies by readers trained using updated reading methodology. The scans in this study came from subjects who had Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer's Disease
    Keywords
    Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    Single
    Allocation
    N/A
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Independent, blinded reader trainees
    Arm Type
    Experimental
    Arm Description
    Seven practicing nuclear medicine physicians with no prior training in reading scans from florbetapir-PET, or other amyloid imaging agents.
    Intervention Type
    Drug
    Intervention Name(s)
    florbetapir F 18
    Other Intervention Name(s)
    18F-AV-45, Amyvid, florbetapir
    Intervention Description
    IV injection, 370MBq (10mCi), single dose (intervention for Study A05 participants, source of scans for this study)
    Primary Outcome Measure Information:
    Title
    Inter-reader Agreement - Median Kappa Statistic
    Description
    Seven readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Simple kappa statistics were calculated for each reader versus the other 6 readers. Primary outcome measure was the median kappa of each reader versus the other 6 readers.
    Time Frame
    50-60 min after injection
    Secondary Outcome Measure Information:
    Title
    Overall Inter-reader Agreement - Fleiss' Kappa
    Description
    Seven readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Fleiss' kappa was calculated across all inter-reader comparisons.
    Time Frame
    50-60 min after injection

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Participants: Inclusion Criteria AD: Male or female >=50 years of age Meet National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) criteria for probable AD with Mini-Mental State Examination (MMSE) score of 10-24 Inclusion Criteria MCI: Male or female >=50 years of age Have a Clinical Dementia Rating (CDR) of 0.5 MMSE >24 Exclusion Criteria: Have a history or current diagnosis of other neurologic disease Have had or currently have a diagnosis of other neurodegenerative disease Have participated in experimental therapy targeted to amyloid plaque Readers: •Private nuclear medicine physicians with no prior training in reading florbetapir-PET scans
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chief Medical Officer
    Organizational Affiliation
    Avid Radiopharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of Inter-reader Reliability Using Images From Subjects With Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI)

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