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

Completed · Phase 2

Conditions studied: Down Syndrome, Amyloid Beta-protein

In brief

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.

Key facts

Study ID

NCT00928304

Run by

Lantheus Biosciences Ltd.

People needed

109

Starts

2009-06-01

Expected to finish

2011-01-01

Last updated by the study team

2014-03-05

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Sun City, Arizona, United States
• Study site — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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