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

This study has been completed.
Information provided by:
GE Healthcare Identifier:
First received: September 13, 2005
Last updated: May 15, 2007
Last verified: May 2007
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
Vascular Dementia
Drug: DatSCAN
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00209456

Amersham Buchler GmbH Co. KG
Ismaning, Germany
Sponsors and Collaborators
GE Healthcare
Study Director: Marc Pignot, PhD GE Healthcare
  More Information Identifier: NCT00209456     History of Changes
Other Study ID Numbers: PDT301 
Study First Received: September 13, 2005
Last Updated: May 15, 2007
Health Authority: Austria: Federal Ministry for Health and Women
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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

Additional relevant MeSH terms:
Dementia, Vascular
Lewy Body Disease
Arterial Occlusive Diseases
Basal Ganglia Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Intracranial Arteriosclerosis
Mental Disorders
Movement Disorders
Nervous System Diseases
Neurocognitive Disorders
Neurodegenerative Diseases
Parkinsonian Disorders
Vascular Diseases processed this record on May 25, 2016