Trial Outcomes & Findings for Evaluation of Inter-reader Reliability Using Images From Subjects With Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) (NCT NCT01565382)
NCT ID: NCT01565382
Last Updated: 2022-08-16
Results Overview
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.
COMPLETED
PHASE3
40 participants
50-60 min after injection
2022-08-16
Participant Flow
NO SUBJECTS WERE ENROLLED IN THIS STUDY - this study re-read 40 scans obtained from 25 mild cognitive impairment (MCI) subjects and 15 Alzheimer's Disease (AD) subjects randomly selected from Study A05 (NCT00702143).
Participant milestones
| Measure |
A05 Florbetapir-PET Scans
Subjects who received a valid florbetapir-PET scan in Study A05 (NCT00702143)
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Inter-reader Reliability Using Images From Subjects With Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI)
Baseline characteristics by cohort
| Measure |
A05 Florbetapir-PET Scans
n=40 Participants
Subjects who received a valid florbetapir-PET scan in Study A05 (NCT00702143)
|
|---|---|
|
Age, Continuous
|
72.7 years
STANDARD_DEVIATION 9.38 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 50-60 min after injectionPopulation: Seven private practice nuclear medicine physicians with no prior training in reading florbetapir-PET scans each rated 40 florbetapir-PET scans (7 readers x 40 scans = 280 scan reads) as either amyloid positive or negative.
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.
Outcome measures
| Measure |
A05 Florbetapir-PET Scans
n=280 florbetapir PET scan reads
Subjects who received a valid florbetapir-PET scan in Study A05(NCT00702143)
|
|---|---|
|
Inter-reader Agreement - Median Kappa Statistic
Reader 1
|
0.72 median kappa
|
|
Inter-reader Agreement - Median Kappa Statistic
Reader 2
|
0.70 median kappa
|
|
Inter-reader Agreement - Median Kappa Statistic
Reader 3
|
0.25 median kappa
|
|
Inter-reader Agreement - Median Kappa Statistic
Reader 4
|
0.75 median kappa
|
|
Inter-reader Agreement - Median Kappa Statistic
Reader 5
|
0.68 median kappa
|
|
Inter-reader Agreement - Median Kappa Statistic
Reader 6
|
0.83 median kappa
|
|
Inter-reader Agreement - Median Kappa Statistic
Reader 7
|
0.68 median kappa
|
SECONDARY outcome
Timeframe: 50-60 min after injectionPopulation: Seven private practice nuclear medicine physicians with no prior training in reading florbetapir-PET scans each rated 40 florbetapir-PET scans (7 readers x 40 scans = 280 scan reads) as either amyloid positive or negative.
Seven readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Fleiss' kappa was calculated across all inter-reader comparisons.
Outcome measures
| Measure |
A05 Florbetapir-PET Scans
n=280 florbetapir PET scans
Subjects who received a valid florbetapir-PET scan in Study A05(NCT00702143)
|
|---|---|
|
Overall Inter-reader Agreement - Fleiss' Kappa
|
0.61 Fleiss' kappa
|
Adverse Events
A05 Florbetapir-PET Scans
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60