Trial Condition(s):
Down Syndrome, Amyloid beta-protein
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
Bayer Identifier:
14311
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site New Haven, United States, 06510 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sun City, United States, 85351 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Sensitivity and specificity of the independent visual assessment of detecting cerebral amyloid-betaTimeframe: One scanning period after injection
Secondary Outcome
- Adverse Event collectionTimeframe: Over 8 days
- Evaluate of the proposed visual assessment procedure and subsequent classificationTimeframe: Once during treatment phase
Additional Information
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