check_circleStudy Completed
Alzheimer Disease, Amyloid beta-Protein
Bayer Identifier:
91783
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Florbetaben (BAY94-9172) PET (Positron Emission Tomography) imaging in MCI (mild cognitive impairment) patients
Trial purpose
The aim of the study is to investigate whether Florbetaben-BAY94-9172 positron emission tomography (PET) has any ability to distinguish patients with mild cognitive impairment (MCI) progressing to Alzheimer's disease (AD) from those with MCI not progressing to AD.
Key Participants Requirements
Sex
BothAge
60 - N/ATrial summary
Enrollment Goal
45Trial Dates
June 2008 - December 2011Phase
Phase 1Could I Receive a placebo
NoProducts
NEURACEQ (Florbetaben F-18, BAY94-9172)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Department of Nuclear Medicine and Centre for PET | Heidelberg, 3084, Australia |
Primary Outcome
- Quantitative assessment of neocortical SUVRs (Standard Uptake Value Ratios) as a measure of BAY94-9172 bindingdate_rangeTime Frame:1 scanning period post injection to be evaluated at baseline, 12 months and 24 monthsenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Percentage of normal and abnormal scans in patients with MCI progressing to AD and those who do not progressdate_rangeTime Frame:1 scanning period post injection to be evaluated at baseline, at 12 months and at 24 monthsenhanced_encryptionnoSafety Issue:
- Brain ß-amyloid plaque load (BAPL) based on visual assessmentdate_rangeTime Frame:2 scanning periods post injection to be evaluated each at baseline, at 12 months, and at 24 monthsenhanced_encryptionnoSafety Issue:
- Regional cortical tracer binding score (RCTB) in patients with MCdate_rangeTime Frame:2 scanning periods post injection to be evaluated each at baseline, at 12 months, and at 24 monthsenhanced_encryptionnoSafety Issue:
- Number and proportion of normal and abnormal scans based on Brain ß-amyloid plaque load (BAPL) in patients with MCI converting to AD and those who do not progressdate_rangeTime Frame:2 scanning periods post injection to be evaluated each at baseline, at 12 months, and at 24 monthsenhanced_encryptionnoSafety Issue:
- Sensitivity and specificity of BAY94-9172 PET imaging at baseline in the detection of significant brain ß-amyloid plaque load in patients with MCI progressing to AD compared to those who do not progressdate_rangeTime Frame:2 scanning periods post injection to be evaluated at baselineenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
DiagnosticAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1