check_circleStudy Completed

Down Syndrome, Amyloid beta-protein

Bayer Identifier:

14311

ClinicalTrials.gov Identifier:

NCT00928304

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial 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.

Key Participants Requirements

Sex

Both

Age

40 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
109
Trial Dates
June 2009 - January 2011
Phase
Phase 2
Could I Receive a placebo
No
Products
NEURACEQ (Florbetaben F-18, BAY94-9172)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
New Haven, 06510, United States
Completed
Sun City, 85351, United States

Primary Outcome

  • Sensitivity and specificity of the independent visual assessment of detecting cerebral amyloid-beta
    date_rangeTime Frame:
    One scanning period after injection
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Adverse Event collection
    date_rangeTime Frame:
    Over 8 days
    enhanced_encryption
    Safety Issue:
    yes
  • Evaluate of the proposed visual assessment procedure and subsequent classification
    date_rangeTime Frame:
    Once during treatment phase
    enhanced_encryption
    Safety Issue:
    no

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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