Dopamine Transporter Scintigraphy Imaging (DAT-Imaging) in Patients With Lewy Body Dementia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00209456|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : May 16, 2007
|Condition or disease||Intervention/treatment||Phase|
|Lewy Body Dementia Non-DLB Dementia Alzheimer’s Vascular Dementia||Drug: DatSCAN||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||326 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title|
|Study Start Date :||November 2003|
U.S. FDA Resources
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209456
|Amersham Buchler GmbH Co. KG|
|Study Director:||Marc Pignot, PhD||GE Healthcare|