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Diagnostic of Lewy Body Dementia by Combining Scintigraphy (SPECT) Using a Specific Transporter and Magnetic Resonance Imaging (MRI) (DatScan)

Primary Purpose

Lewy Body Dementia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Single photon emission computed tomography and Magnetic Resonance Imaging
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lewy Body Dementia

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with alzheimer disease following NINCDS-ADRDA scale or Lewy body dementia following Mc Keith scale.
  • Aged between 65 et 90 years
  • Patients with visual hallucination
  • Patients with helping people
  • Patients with MMSE (Mini Mental State Examination) equal or more than 18.
  • Signed consent

Exclusion Criteria:

  • Hospitalized patients without their consent
  • Patients who have not passed the neuropsychological tests
  • Patients with a MMSE less than 18
  • Patients without helping
  • Patients with no visual hallucinations
  • Patients with severe somatic pathology.
  • Pregnancy
  • Allergy to iodine

Sites / Locations

  • Département de Gérontologie - Chu Limoges
  • Pôle de psychiatrie du sujet âgé - CH Esquirol
  • Service de Neurologie - CHU de Limoges

Outcomes

Primary Outcome Measures

SPECT and MRI differential imaging

Secondary Outcome Measures

Neuropsychological analysis

Full Information

First Posted
December 27, 2008
Last Updated
August 26, 2009
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT00820937
Brief Title
Diagnostic of Lewy Body Dementia by Combining Scintigraphy (SPECT) Using a Specific Transporter and Magnetic Resonance Imaging (MRI)
Acronym
DatScan
Official Title
Interest of the Combination of the DaTSCAN Scintigraphy and MRI Scan in the Differential Diagnosis of Lewy Body Dementia From Alzheimer Disease in Patients With Hallucinations
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Limoges

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to improve the diagnostic of Lewy body dementia by combining the scintigraphy (SPECT) usig a spécific transporter and magnetic resonance imaging (MRI).
Detailed Description
Lewy body dementia is the second leading cause of dementia in France after degenerative Alzheimer's disease. However its dignosis is difficult. Its comes in large part from the similarity of symptoms with another close dementia syndrome : the Alzheimer disease . Therfore, its is very important to have a mean to distinguish between the two dementias. One highlight of the Lewy body dementia process being dopaminergic degeneration, the use of specific radioactive tracers is thought to be the way. The radiotracer that has the greatest advantage for these explorations is currently the DaTSCAN because it binds specifically on the dopamine transporter and can be used in Single photon emission computed tomography (SPECT). The aim of this study is to improve the performance of imaging in the diagnosis of dementia by combining scintigraphy (SPECT) and magnetic resonance imaging (MRI) in the exploration of the striatal region . The development of this method applied to a population of subjects, with hallucinations and cognitive disorders, should demonstrate the value and complementarity of metabolic images (SPECT) and morphological (MRI) within the differential diagnosis of Lewy body dementia and the Alzheimer disease . From a methodological point of view, the patient will be included in hospital and will have a clinical diagnosis defined according to the criteria of dementia NINCDS-ADRDA for the Alzheimer disease and Mc-Keith criteria for Lewy body dementia. Their MMSE will be over 18 and they have in common recurrent visual hallucinations. After the inclusion, two steps must be distinguished, a neuropsychological evaluation stage and an scitigraphy exploration . Before the SPECT , all patients should have an MRI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lewy Body Dementia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Single photon emission computed tomography and Magnetic Resonance Imaging
Primary Outcome Measure Information:
Title
SPECT and MRI differential imaging
Time Frame
Visit 1
Secondary Outcome Measure Information:
Title
Neuropsychological analysis
Time Frame
Visit 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with alzheimer disease following NINCDS-ADRDA scale or Lewy body dementia following Mc Keith scale. Aged between 65 et 90 years Patients with visual hallucination Patients with helping people Patients with MMSE (Mini Mental State Examination) equal or more than 18. Signed consent Exclusion Criteria: Hospitalized patients without their consent Patients who have not passed the neuropsychological tests Patients with a MMSE less than 18 Patients without helping Patients with no visual hallucinations Patients with severe somatic pathology. Pregnancy Allergy to iodine
Facility Information:
Facility Name
Département de Gérontologie - Chu Limoges
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
Pôle de psychiatrie du sujet âgé - CH Esquirol
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
Service de Neurologie - CHU de Limoges
City
Limoges
ZIP/Postal Code
87000
Country
France

12. IPD Sharing Statement

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Diagnostic of Lewy Body Dementia by Combining Scintigraphy (SPECT) Using a Specific Transporter and Magnetic Resonance Imaging (MRI)

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