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

Primary Purpose

Lewy Body Dementia, Non-DLB Dementia, Alzheimer's

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
DatSCAN
Sponsored by
GE Healthcare
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lewy Body Dementia focused on measuring Lewy Body Dementia, non-DLB dementia, Dopamine Transporter, Striatal Uptake

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Amersham Buchler GmbH Co. KG

Outcomes

Primary Outcome Measures

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

Secondary Outcome 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

Full Information

First Posted
September 13, 2005
Last Updated
May 15, 2007
Sponsor
GE Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT00209456
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GE Healthcare

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lewy Body Dementia, Non-DLB Dementia, Alzheimer's, Vascular Dementia
Keywords
Lewy Body Dementia, non-DLB dementia, Dopamine Transporter, Striatal Uptake

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
326 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
DatSCAN
Primary Outcome Measure Information:
Title
Sensitivity and specificity of DaTSCAN SPECT scans in differentiating between probable dementia with Lewy Bodies (DLB) and non-DLB dementia subjects.
Secondary Outcome Measure Information:
Title
Accuracy, positive predictive value and negative predictive value of DaTSCAN SPECT
Title
Semi-quantitative analysis of the striatal uptake ratios of DaTSCAN SPECT images.
Title
Impact of DaTSCAN SPECT analysis on the confidence of diagnosis.
Title
Findings in relation to probable, possible and no-DLB.
Title
Efficacy analysis at 12-month follow-up period.
Title
Safety profile

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Pignot, PhD
Organizational Affiliation
GE Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
Amersham Buchler GmbH Co. KG
City
Ismaning
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24993764
Citation
O'Brien JT, Oertel WH, McKeith IG, Grosset DG, Walker Z, Tatsch K, Tolosa E, Sherwin PF, Grachev ID. Is ioflupane I123 injection diagnostically effective in patients with movement disorders and dementia? Pooled analysis of four clinical trials. BMJ Open. 2014 Jul 3;4(7):e005122. doi: 10.1136/bmjopen-2014-005122.
Results Reference
derived

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

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