Phase 3
Completed N=40
Evaluation of Inter-reader Reliability Using Images From Subjects With Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI)
Source: ClinicalTrials.gov NCT01565382 ↗Enrolled (actual)
40
Serious AEs
—
Results posted
Jun 2012
Primary outcomePrimary: Inter-reader Agreement - Median Kappa Statistic — 0.72; 0.70; 0.25; 0.75 median kappa
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inter-reader Agreement - Median Kappa Statistic |
0.72; 0.70; 0.25; 0.75; 0.68; 0.83 | — |
| SECONDARY Overall Inter-reader Agreement - Fleiss' Kappa |
0.61 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01565382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.