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
1 other identifier
interventional
326
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedMay 16, 2007
May 1, 2007
September 13, 2005
May 15, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sensitivity and specificity of DaTSCAN SPECT scans in differentiating between probable dementia with Lewy Bodies (DLB) and non-DLB dementia subjects.
Secondary Outcomes (6)
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.
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GE Healthcarelead
Study Sites (1)
Amersham Buchler GmbH Co. KG
Ismaning, Germany
Related Publications (1)
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.
PMID: 24993764DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Marc Pignot, PhD
GE Healthcare
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
November 1, 2003
Last Updated
May 16, 2007
Record last verified: 2007-05