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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

May 15, 2007

Start Date ^ICMJE

November 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00209456 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

- 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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title

Brief Summary

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.

Detailed Description

GEHC had decided notto provide this detail

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Lewy Body Dementia
Non-DLB Dementia
Alzheimer’s
Vascular Dementia

Intervention ^ICMJE

Drug: DatSCAN

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

326

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

55 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00209456

Responsible Party

Study ID Numbers ^ICMJE

PDT301

Study Sponsor ^ICMJE

GE Healthcare

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Marc Pignot, PhD

GE Healthcare

Information Provided By

GE Healthcare

Verification Date

May 2007

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