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

NCT01565382 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 18F-AV-45-A09
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Alzheimer's Disease

Keywords

Amyloid imaging; Positron Emission Tomography; 18F-AV-45; florbetapir F 18; Diagnostic imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall Inter-reader Agreement - Fleiss' Kappa

  50-60 min after injection

Study Arms (1)

Independent, blinded reader trainees

EXPERIMENTAL

Seven practicing nuclear medicine physicians with no prior training in reading scans from florbetapir-PET, or other amyloid imaging agents.

Drug: florbetapir F 18

Interventions

florbetapir F 18 DRUG

IV injection, 370MBq (10mCi), single dose (intervention for Study A05 participants, source of scans for this study)

Also known as: 18F-AV-45, Amyvid, florbetapir

Independent, blinded reader trainees

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Male or female \>=50 years of age
• Have a Clinical Dementia Rating (CDR) of 0.5
• MMSE \>24

You may not qualify if:

• 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

Sponsors & Collaborators

• Avid Radiopharmaceuticals: lead

MeSH Terms

Conditions

Alzheimer Disease

Interventions

florbetapir

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Avid Radiopharmaceuticals

clinicaloperations@avidrp.com

215-298-0700

Study Officials

• Chief Medical Officer

  Avid Radiopharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: SINGLE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2012
• First Posted: March 28, 2012
• Study Start: February 1, 2011
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: August 16, 2022
• Results First Posted: June 27, 2012

Record last verified: 2022-07