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Dopamine Transporter Scintigraphy Imaging (DAT-Imaging) in Patients With Lewy Body Dementia

This study has been completed.
Sponsor:
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00209456
First received: September 13, 2005
Last updated: May 15, 2007
Last verified: May 2007

September 13, 2005
May 15, 2007
November 2003
Not Provided
Sensitivity and specificity of DaTSCAN SPECT scans in differentiating between probable dementia with Lewy Bodies (DLB) and non-DLB dementia subjects.
- Sensitivity and specificity of DaTSCAN SPECT scans in differentiating between probable dementia with Lewy Bodies (DLB) and non-DLB dementia subjects.
Complete list of historical versions of study NCT00209456 on ClinicalTrials.gov Archive Site
  • 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
  • - 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
Not Provided
Not Provided
 
Dopamine Transporter Scintigraphy Imaging (DAT-Imaging) in Patients With Lewy Body Dementia
GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title

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.

GEHC had decided notto provide this detail

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Lewy Body Dementia
  • Non-DLB Dementia
  • Alzheimer’s
  • Vascular Dementia
Drug: DatSCAN
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
326
Not Provided
Not Provided

Inclusion Criteria:

  • Subjects must be adults between 55 to 90 years of age with an established diagnosis for dementia in accordance with DSM-IV criteria and have to fulfil at least one of the following: The ICC criteria for probable and possible DLB, the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer Disease and Related Disorders Association (NINCDS-ADRDA) for Alzheimer’s Disease (AD), or the National Institute of Neurological and Communicative Disorders and Association Internationale Pour la Recherche et l’Enseignement en Neurosciences (NINCS-AIREN) for Vascular Dementia (VaD).

Exclusion Criteria:

  • Subjects are not eligible if they have a Mini Mental State Examination (MMSE) score of <10 and use medication known or suspected to interact with the striatal uptake DaTSCAN to the dopamine transporter.
  • Furthermore subjects are not eligible if they were diagnosed with idiopathic Parkinson’s Disease (PD), with persistent severe depression, normal pressure hydrocephalus, multiple system atrophy, cortico-basal degeneration or Huntington’s Chorea Disease.
Both
55 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00209456
PDT301
Not Provided
Not Provided
GE Healthcare
Not Provided
Study Director: Marc Pignot, PhD GE Healthcare
GE Healthcare
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP