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

Life Molecular Imaging

Status and phase: Completed; Phase 2

Conditions: Down Syndrome; Amyloid Beta-protein

Treatments: Drug: Florbetaben (BAY94-9172)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00928304

14311

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

109 participants in 1 patient group

Florbetaben (BAY94-9172)

Experimental group

Treatment:

Drug: Florbetaben (BAY94-9172)