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Phase II Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00928304
First Posted: June 25, 2009
Last Update Posted: March 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Piramal Imaging SA
June 24, 2009
June 25, 2009
December 9, 2013
January 28, 2014
March 5, 2014
June 2009
January 2011   (Final data collection date for primary outcome measure)
Sensitivity of the Independent Visual Assessment of Detecting Cerebral Amyloid-beta in Individuals With Down Syndrome and Specificity in Subjects Without Down Syndrome [ Time Frame: 100-120 min ]
The primary variables are sensitivity (percentage of DS subjects positive for cerebral beta-amyloid) and specificity (percentage of healthy volunteers negative for cerebral beta-amyloid) of brain uptake of florbetaben based on the majority read of the visual assessment by three independent blinded readers of PET images obtained 100 to 120 minutes post-injection of florbetaben.
Sensitivity and specificity of the independent visual assessment of detecting cerebral amyloid-beta [ Time Frame: One scanning period after injection ]
Complete list of historical versions of study NCT00928304 on ClinicalTrials.gov Archive Site
  • Sensitivity Results in the Down Syndrome Age Subgroups [ Time Frame: 100 - 120 min ]
    The majority read sensitivity (percentage of DS subjects positive for cerebral beta-amyloid by majority read) was computed for the group of DS subjects with age equal to or below the median age (DS-young) and for DS subjects with age above the median age (DS-old). The median age was 46 yrs, with 3 subjects being exactly 46 yrs old. As defined, these subjects were assigned to the DS-young group.
  • Quantitative Parameters Standard Uptake Value Ratio [ Time Frame: 100 - 120 min p.i. ]
    The Standard Uptake Value Ratios for florbetaben signal in the frontal cortex, posterior cingulate, lateral temporal cortex, parietal cortex, and cerebellum (white matter) were determined as a quantitative measure of tracer uptake. The SUV is defined as the ratio of (1) the tissue radioactivity concentration c (in MBq/kg) at time point t, and (2) the injected activity (in MBq, extrapolated to the same time t) divided by the body weight (in kg). These SUV numbers from regions of interest were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference.
  • Consistency Between Visual and Quantitative Efficacy [ Time Frame: 100 - 120 min ]
    For a comparison of the results of the visual assessment with the quantitative assessment, descriptive Standardized Uptake Value Ratio (SUVR) statistics were computed separately for DS subjects with an abnormal/normal majority read of the PET scan (DS-PET+/DS-PET-). The SUV is defined as the ratio of (1) the tissue radioactivity concentration c (in MBq/kg) at time point t, and (2) the injected activity (in MBq, extrapolated to the same time t) divided by the body weight (in kg). These SUV numbers from regions of interest were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference.
  • Adverse Event collection [ Time Frame: Over 8 days ]
  • Evaluate of the proposed visual assessment procedure and subsequent classification [ Time Frame: Once during treatment phase ]
Not Provided
Not Provided
 
Phase II Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid.
An Open-Label, Non-Randomized Study to Evaluate the Efficacy and Safety of BAY94-9172 (ZK 6013443) Positron Emission Tomography (PET) for Detection of Cerebral ß-Amyloid in Individuals With Down Syndrome Compared to Individuals Without Down Syndrome
To determine the sensitivity of the visual assessment of BAY94-9172 PET images in detecting cerebral β-amyloid in individuals with Down Syndrome (DS) and specificity in individuals without DS. Given that individuals with Down Syndrome develop β-amyloid pathology over the age of 40, the clinical diagnosis of Down Syndrome will serve as the standard of truth.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Down Syndrome
  • Amyloid Beta-protein
Drug: Florbetaben (BAY94-9172)
300 megabecquerels (MBq) as single IV injection of 2 to 10 mL
Experimental: Florbetaben (BAY94-9172)
Intervention: Drug: Florbetaben (BAY94-9172)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
109
January 2011
January 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Study participants were individuals with DS and healthy volunteers (HVs).

  • Main inclusion criteria for individuals without DS

    • >=21 and <= 40 years of age
    • Mini-Mental State Examination (MMSE) >= 28
    • Clinical Dementia Rating (CDR) of 0
  • Main inclusion criteria for individuals with DS

    • >= 40 years of age

Exclusion Criteria:

  • Main exclusion criteria for both groups

    • Unstable medical or psychiatric condition, study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00928304
14311
No
Not Provided
Not Provided
Piramal Imaging SA
Piramal Imaging SA
Not Provided
Study Director: Bayer Study Director Bayer
Piramal Imaging SA
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP