Clinical Trial: Imaging Characteristics of Florbetapir 18F in Patients With Frontotemporal Dementia, Alzheimer's Disease and Normal Controls.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Study Evaluating the Imaging Characteristics of Florbetapir 18F (18F-AV-45) in Patients With Frontotemporal Dementia Compared to Patients With Alzheimer's Disease and No

Brief Summary: Study 18F-AV-45-010 is designed to evaluate the cerebral uptake of florbetapir 18F as measured by PET imaging in frontotemporal disorder (FTD) in comparison to cognitively normal volunteers and subjects with Alzheimer's disease (AD).

Detailed Summary:
Sponsor: Avid Radiopharmaceuticals

Current Primary Outcome:

  • Qualitative Amyloid Image Assessment [ Time Frame: 50-60 min after injection ]
    Four readers blinded to all clinical information classified florbetapir Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read classification is presented as either positive, negative or tied.
  • Quantitative Amyloid Image Assessment [ Time Frame: 50-60 minutes after injection ]
    The effect of diagnostic group on mean total cortical grey matter florbetapir binding relative to cerebellar cortex is presented as standard uptake value ratios (SUVr).


Original Primary Outcome:

  • Qualitative Amyloid Image Assessment [ Time Frame: 50-60 min after injection ]
    Two readers blinded to all clinical information classified florbetapir Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid.
  • Quantitative Amyloid Image Assessment [ Time Frame: 50-60 minutes after injection ]
    Standardized Uptake Value ratios (SUVRs) were calculated for the following regions of interest (ROI): mesial temporal lobe, temporal lobe, frontal lobe, anterior cingulate cortex, posterior cingulate cortex, parietal lobe, occipital lobe, central subcortical and the brainstem. SUVR is the ratio of tracer uptake in a predefined ROI, relative to uptake in the cerebellar grey matter.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Avid Radiopharmaceuticals

Dates:
Date Received: June 27, 2013
Date Started: September 2009
Date Completion:
Last Updated: September 16, 2014
Last Verified: September 2014