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

Sponsor

GE Healthcare (Industry)

Overall Status

Completed

CT.gov ID

NCT00209456

Collaborator

(none)

326

Enrollment

Location

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Lewy Body Dementia Non-DLB Dementia Alzheimer's Vascular Dementia	Drug: DatSCAN	Phase 3

Detailed Description

GEHC had decided notto provide this detail

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Nov 1, 2003

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.