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

Official Title: “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

Intervention(s) in this Clinical Trial

• Drug: DatSCAN

Primary Measures

• Sensitivity and specificity of DaTSCAN SPECT scans in differentiating between probable dementia with Lewy Bodies (DLB) and non-DLB dementia subjects.

Secondary Measures

• 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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: GE Healthcare Industry

Overall Clinical Trial Officials and Contacts

Marc Pignot, PhD Study Director GE Healthcare  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00209456

Study ID Number: PDT301

ClinicalTrials.gov Identifier: NCT00209456

Health Authority: Austria: Federal Ministry for Health and Women