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Dopamine Transporter Scintigraphy Imaging (DAT-Imaging) in Patients With Lewy Body Dementia
This study has been completed.
First Received: September 13, 2005   Last Updated: May 15, 2007   History of Changes
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

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

Resource links provided by NLM:


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

No publications provided

Study ID Numbers: PDT301
Study First Received: September 13, 2005
Last Updated: May 15, 2007
ClinicalTrials.gov Identifier: NCT00209456     History of Changes
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
Lewy Body Dementia
Ganglion Cysts
Basal Ganglia Diseases
Vascular Diseases
Central Nervous System Diseases
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
Dopamine Agents
Parkinsonian Disorders
Dementia
Delirium

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Basal Ganglia Diseases
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Arteriosclerosis
Neurodegenerative Diseases
Lewy Body Disease
Brain Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Intracranial Arteriosclerosis
Delirium, Dementia, Amnestic, Cognitive Disorders
Movement Disorders
Mental Disorders
Dementia, Vascular
Cardiovascular Diseases
Parkinsonian Disorders
Dementia

ClinicalTrials.gov processed this record on July 02, 2009