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

Phase 3

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: florbetapir F 18

• Registration Number: NCT01565382
• Lead Sponsor: Avid Radiopharmaceuticals

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Study First Submitted: 2012-03-26
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-28
• Results First Submitted: 2012-04-06
• Results First Submitted QC: 2012-05-23
• Results First Posted: 2012-06-27
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Independent, blinded reader trainees	florbetapir F 18	Seven practicing nuclear medicine physicians with no prior training in reading scans from florbetapir-PET, or other amyloid imaging agents.

Primary Outcome Measures

Name	Time	Method
Inter-reader Agreement - Median Kappa Statistic	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

Name	Time	Method
Overall Inter-reader Agreement - Fleiss' Kappa	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.