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

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ClinicalTrials.gov Identifier: NCT01565382
Recruitment Status : Completed
First Posted : March 28, 2012
Results First Posted : June 27, 2012
Last Update Posted : June 27, 2012
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Study Description
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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).

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: florbetapir F 18 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
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 Start Date : February 2011
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Drug: florbetapir F 18
    IV injection, 370MBq (10mCi), single dose
    Other Names:
    • 18F-AV-45
    • Amyvid
    • florbetapir

Outcome Measures
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Primary Outcome Measures :
  1. Inter-reader Agreement - Median Kappa Statistic [ Time Frame: 50-60 min after injection ]
    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 :
  1. Overall Inter-reader Agreement - Fleiss' Kappa [ Time Frame: 50-60 min after injection ]
    Seven readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Fleiss' kappa was calculated across all inter-reader comparisons.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01565382


Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
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Study Director: Chief Medical Officer Avid Radiopharmaceuticals
More Information
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Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01565382    
Other Study ID Numbers: 18F-AV-45-A09
First Posted: March 28, 2012    Key Record Dates
Results First Posted: June 27, 2012
Last Update Posted: June 27, 2012
Last Verified: May 2012
Keywords provided by Avid Radiopharmaceuticals:
Amyloid imaging
Positron Emission Tomography
18F-AV-45
florbetapir F 18
Diagnostic imaging
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders