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

Sponsored by:	GE Healthcare
Information provided by:	GE Healthcare
ClinicalTrials.gov Identifier:	NCT00209456

Purpose

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	Intervention	Phase
Lewy Body Dementia Non-DLB Dementia Alzheimer’s Vascular Dementia	Drug: DatSCAN	Phase III

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia

MedlinePlus related topics: Dementia Lewy Body Disease Nuclear Scans

Drug Information available for: Dopamine Dopamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title

Further study details as provided by GE Healthcare:

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

Estimated Enrollment:	326
Study Start Date:	November 2003

Detailed Description:

GEHC had decided notto provide this detail

Eligibility

Ages Eligible for Study:	55 Years to 90 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209456

Locations

Germany
Amersham Buchler GmbH Co. KG
Ismaning, Germany

Sponsors and Collaborators

GE Healthcare

Investigators

Study Director:

Marc Pignot, PhD

GE Healthcare

More Information

Study ID Numbers:	PDT301
Study First Received:	September 13, 2005
Last Updated:	May 15, 2007
ClinicalTrials.gov Identifier:	NCT00209456
Health Authority:	Austria: Federal Ministry for Health and Women; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Norway: Norwegian Medicines Agency; Portugal: National Pharmacy and Medicines Institute; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GE Healthcare:

Lewy Body Dementia
non-DLB dementia
Dopamine Transporter
Striatal Uptake

Study placed in the following topic categories:

Arterial Occlusive Diseases
Ganglion Cysts
Basal Ganglia Diseases
Vascular Diseases
Central Nervous System Diseases
Lewy body dementia
Arteriosclerosis
Neurodegenerative Diseases
Lewy Body Disease
Brain Diseases
Cerebrovascular Disorders

Intracranial Arterial Diseases
Cognition Disorders
Intracranial Arteriosclerosis
Dopamine
Delirium, Dementia, Amnestic, Cognitive Disorders
Movement Disorders
Mental Disorders
Dementia, Vascular
Parkinsonian Disorders
Dementia
Delirium

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009