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

Vascular Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00209456
• Other study ID #: PDT301
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: May 15, 2007
• Start date: November 2003

Study information

• Verified date: May 2007
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and WomenCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthNorway: Norwegian Medicines AgencyPortugal: National Pharmacy and Medicines InstituteSpain: Spanish Agency of MedicinesSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Description:

GEHC had decided notto provide this detail

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 90 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Alzheimer’s
• Dementia
• Dementia, Vascular
• Lewy Body Dementia
• Lewy Body Disease
• Non-DLB Dementia
• Vascular Dementia

Intervention

Drug:
• DatSCAN

Locations

Country	Name	City	State
Germany	Amersham Buchler GmbH Co. KG	Ismaning

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of DaTSCAN SPECT scans in differentiating between probable dementia with Lewy Bodies (DLB) and non-DLB dementia subjects.
Secondary	Accuracy, positive predictive value and negative predictive value of DaTSCAN SPECT
Secondary	Semi-quantitative analysis of the striatal uptake ratios of DaTSCAN SPECT images.
Secondary	Impact of DaTSCAN SPECT analysis on the confidence of diagnosis.
Secondary	Findings in relation to probable, possible and no-DLB.
Secondary	Efficacy analysis at 12-month follow-up period.
Secondary	Safety profile