Dopamine Transporter Scintigraphy Imaging (DAT-Imaging) in Patients With Lewy Body Dementia
The study is designed to determine the diagnostic efficacy of the visual assessment of SPECT scans in differentiating between probable dementia with Lewy Bodies (DLB) and non-DLB dementia subjects determined by the clinical diagnosis of an independent expert consensus panel used as the standard of truth.
Lewy Body Dementia
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title|
- Sensitivity and specificity of DaTSCAN SPECT scans in differentiating between probable dementia with Lewy Bodies (DLB) and non-DLB dementia subjects.
- Accuracy, positive predictive value and negative predictive value of DaTSCAN SPECT
- Semi-quantitative analysis of the striatal uptake ratios of DaTSCAN SPECT images.
- Impact of DaTSCAN SPECT analysis on the confidence of diagnosis.
- Findings in relation to probable, possible and no-DLB.
- Efficacy analysis at 12-month follow-up period.
- Safety profile
|Study Start Date:||November 2003|
GEHC had decided notto provide this detail
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209456
|Amersham Buchler GmbH Co. KG|
|Study Director:||Marc Pignot, PhD||GE Healthcare|