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Phase III Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid Compared to Histopathology

NCT01020838 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2016-05-27

Study results available
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Summary

To determine the sensitivity and specificity of the visual assessment of tracer uptake in the Florbetaben PET images compared to histological verification of the presence or absence of cerebral β-amyloid in the respective histopathologic post mortem specimens as the standard of truth

Conditions

  • Alzheimer Disease

Interventions

DRUG

Florbetaben (BAY94-9172)

Single intravenous injection 1-5ml, 300 MBq (+/- 20%)

Sponsors & Collaborators

  • Life Molecular Imaging SA

    lead INDUSTRY

Principal Investigators

  • Piramal Imaging SA Study Director · Life Molecular Imaging SA

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-09-30
Completion
2013-12-31

Countries

  • United States
  • Australia
  • France
  • Germany
  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01020838 on ClinicalTrials.gov