Dopamine Transporter Scintigraphy Imaging (DAT-Imaging) in Patients With Lewy Body Dementia
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|ClinicalTrials.gov Identifier: NCT00209456|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : May 16, 2007
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|Condition or disease||Intervention/treatment||Phase|
|Lewy Body Dementia Non-DLB Dementia Alzheimer's Vascular Dementia||Drug: DatSCAN||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||326 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title|
|Study Start Date :||November 2003|
- Sensitivity and specificity of DaTSCAN SPECT scans in differentiating between probable dementia with Lewy Bodies (DLB) and non-DLB dementia subjects.
- 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
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|Ages Eligible for Study:||55 Years to 90 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209456
|Amersham Buchler GmbH Co. KG|
|Study Director:||Marc Pignot, PhD||GE Healthcare|
|Other Study ID Numbers:||
|First Posted:||September 21, 2005 Key Record Dates|
|Last Update Posted:||May 16, 2007|
|Last Verified:||May 2007|
Lewy Body Dementia
Lewy Body Disease
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases
Arterial Occlusive Diseases
Basal Ganglia Diseases