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Phase II Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid in Individuals With Down Syndrome Compared to Individuals Without Down Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Piramal Imaging SA
ClinicalTrials.gov Identifier:
NCT00928304
First received: June 24, 2009
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  Purpose

To determine the sensitivity and specificity of the visual assessment of BAY94-9172 PET images in detecting cerebral β-amyloid in individuals with Down Syndrome (DS) compared to 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.


Condition Intervention Phase
Down Syndrome
Amyloid Beta-protein
 Drug: Florbetaben (BAY94-9172)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Down Syndrome
U.S. FDA Resources

Further study details as provided by Piramal Imaging SA:

Primary Outcome Measures:
  • Sensitivity and specificity of the independent visual assessment of detecting cerebral amyloid-beta [ Time Frame: One scanning period after injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Event collection [ Time Frame: Over 8 days ] [ Designated as safety issue: Yes ]
  • Evaluate of the proposed visual assessment procedure and subsequent classification [ Time Frame: Once during treatment phase ] [ Designated as safety issue: No ]

Enrollment: 109
Study Start Date: June 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Florbetaben (BAY94-9172)
single IV injection of 2 to 10 mL

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Main inclusion criteria for individuals without DS

    • Mini-Mental State Examination (MMSE) which must be >= 28
    • Clinical Dementia Rating (CDR) of 0

  • Main inclusion criteria for individuals with DS

    • must be > 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00928304

Locations
United States, Arizona
Sun City, Arizona, United States, 85351
United States, Connecticut
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Piramal Imaging SA
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Piramal Imaging SA
ClinicalTrials.gov Identifier: NCT00928304     History of Changes
Other Study ID Numbers: 14311
Study First Received: June 24, 2009
Last Updated: May 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Piramal Imaging SA:
Amyloid beta-protein
Down Syndrome

Additional relevant MeSH terms:
Down Syndrome
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
 Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 23, 2013