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Completed

NCT Number: NCT00209456

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

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.

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Key information

Conditions

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

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Amersham Buchler GmbH Co. KG

Ismaning, Germany

About this study

GEHC had decided notto provide this detail

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DatSCAN

Drug

Primary outcomes

  1. Sensitivity and specificity of DaTSCAN SPECT scans in differentiating between probable dementia with Lewy Bodies (DLB) and non-DLB dementia subjects.

Secondary outcomes

  1. Accuracy, positive predictive value and negative predictive value of DaTSCAN SPECT

  2. Semi-quantitative analysis of the striatal uptake ratios of DaTSCAN SPECT images.

  3. Impact of DaTSCAN SPECT analysis on the confidence of diagnosis.

  4. Findings in relation to probable, possible and no-DLB.

  5. Efficacy analysis at 12-month follow-up period.

  6. Safety profile

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Official study title

GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title

Important dates

Study start
2003
First posted
Sep 21, 2005
Registry last updated
May 16, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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