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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Sponsor:

Information provided by:

GE Healthcare

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.

Condition or disease	Intervention/treatment	Phase
Lewy Body Dementia Non-DLB Dementia Alzheimer's Vascular Dementia	Drug: DatSCAN	Phase 3

Detailed Description:

GEHC had decided notto provide this detail

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	326 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title
Study Start Date :	November 2003

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Alzheimer disease Dementia with Lewy bodies

MedlinePlus related topics: Dementia Lewy Body Dementia

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

Arms and Interventions

Outcome Measures

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

Eligibility Criteria

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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

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.

Contacts and Locations

Information from the National Library of Medicine

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

Locations

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Germany
Amersham Buchler GmbH Co. KG
Ismaning, Germany

Sponsors and Collaborators

GE Healthcare

Investigators

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Study Director:	Marc Pignot, PhD	GE Healthcare

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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ClinicalTrials.gov Identifier:	NCT00209456
Other Study ID Numbers:	PDT301
First Posted:	September 21, 2005 Key Record Dates
Last Update Posted:	May 16, 2007
Last Verified:	May 2007

Keywords provided by GE Healthcare:


Lewy Body Dementia non-DLB dementia Dopamine Transporter Striatal Uptake

Additional relevant MeSH terms:

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Dementia Alzheimer Disease Dementia, Vascular Lewy Body Disease Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurocognitive Disorders Mental Disorders Tauopathies Neurodegenerative Diseases Cerebrovascular Disorders	Intracranial Arteriosclerosis Intracranial Arterial Diseases Leukoencephalopathies Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Parkinsonian Disorders Basal Ganglia Diseases Movement Disorders Synucleinopathies

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