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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01565382
• Other study ID #: 18F-AV-45-A09
• Status: Completed
• Phase: Phase 3
• Start date: February 2011
• Est. completion date: February 2011

Study information

• Verified date: July 2022
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• florbetapir F 18
IV injection, 370MBq (10mCi), single dose (intervention for Study A05 participants, source of scans for this study)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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