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
About this trial
This is an interventional diagnostic trial for Lewy Body Dementia
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
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
NCT ID
NCT00820937
First Posted
December 27, 2008
Last Updated
August 26, 2009
Sponsor
University Hospital, Limoges
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
Learn more about this trial
Diagnostic of Lewy Body Dementia by Combining Scintigraphy (SPECT) Using a Specific Transporter and Magnetic Resonance Imaging (MRI)
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