Dopamine Transporter Scintigraphy Imaging (DAT-Imaging) i... | NCT00209456

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

NCT00209456

Sponsor

GE Healthcare

Status

Completed

Last Update Posted

May 16, 2007Estimated

Enrollment

326

Phase

Phase 3

Conditions

Lewy Body Dementia
Non-DLB Dementia
Alzheimer's
Vascular Dementia

Interventions

DatSCAN

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2003

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2007

Last Update Posted Date

May 16, 2007Estimated

Description Module

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.

Detailed Description

GEHC had decided notto provide this detail

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

326

Name	Type	Description	Arm Group Labels	Other Names
DatSCAN	Drug

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Accuracy, positive predictive value and negative predictive value of DaTSCAN SPECT
Semi-quantitative analysis of the striatal uptake ratios of DaTSCAN SPECT images.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Marc Pignot, PhD	GE Healthcare	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24993764	Derived	O'Brien JT, Oertel WH, McKeith IG, Grosset DG, Walker Z, Tatsch K, Tolosa E, Sherwin PF, Grachev ID. Is ioflupane I123 injection diagnostically effective in patients with movement disorders and dementia? Pooled analysis of four clinical trials. BMJ Open. 2014 Jul 3;4(7):e005122. doi: 10.1136/bmjopen-2014-005122.

ID	Term
D020961	Lewy Body Disease
D015140	Dementia, Vascular

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases