Dopamine Transporter Scintigraphy Imaging (DAT-Imaging) in Patients With Lewy Body Dementia
This study has been completed.
Sponsor:
GE Healthcare
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00209456
First received: September 13, 2005
Last updated: May 15, 2007
Last verified: May 2007
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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 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 |
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 More Information
No publications provided
| ClinicalTrials.gov 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 Dementia, Vascular Lewy Body Disease Brain Diseases Central Nervous System Diseases Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Cerebrovascular Disorders Intracranial Arteriosclerosis |
Intracranial Arterial Diseases Leukoencephalopathies Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Parkinsonian Disorders Basal Ganglia Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on May 23, 2013