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:

NCT00928304

EudraCT Number:

Not Available

Study Completed

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
109
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
NEURACEQ (Florbetaben F-18, BAY94-9172)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

New Haven, United States, 06510

Status
Completed
 
Locations

Investigative Site

Sun City, United States, 85351

Status
Completed
 

Trial Design