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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Down Syndrome Amyloid Beta-protein

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Florbetaben (BAY94-9172)

Group Type EXPERIMENTAL

Florbetaben (BAY94-9172)

Intervention Type DRUG

300 megabecquerels (MBq) as single IV injection of 2 to 10 mL

Interventions

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Florbetaben (BAY94-9172)

300 megabecquerels (MBq) as single IV injection of 2 to 10 mL

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

* \>=21 and \<= 40 years of age
* Mini-Mental State Examination (MMSE) \>= 28
* Clinical Dementia Rating (CDR) of 0

* \>= 40 years of age

Exclusion Criteria

* 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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes