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

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Life Molecular Imaging SA; Piramal Imaging SA

Criteria

Inclusion Criteria:

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

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