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

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

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).

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: florbetapir F 18

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Independent, blinded reader trainees; Seven practicing nuclear medicine physicians with no prior training in reading scans from florbetapir-PET, or other amyloid imaging agents.	Drug: florbetapir F 18; IV injection, 370MBq (10mCi), single dose (intervention for Study A05 participants, source of scans for this study); Other Names: Amyvid; 18F-AV-45; florbetapir

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	50-60 min after injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	50-60 min after injection

Collaborators and Investigators

• Sponsor: Avid Radiopharmaceuticals

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: March 26, 2012
• First Submitted That Met QC Criteria: March 27, 2012
• First Posted (Estimate): March 28, 2012

Study Record Updates

• Last Update Posted (Actual): August 16, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Diagnostic imaging; Positron Emission Tomography; Amyloid imaging; 18F-AV-45; florbetapir F 18
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 18F-AV-45-A09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No