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

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ClinicalTrials.gov Identifier: NCT00820937
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : August 27, 2009
Sponsor:
Information provided by:
University Hospital, Limoges

Study Description
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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).

Condition or disease Intervention/treatment Phase
Lewy Body Dementia Procedure: Single photon emission computed tomography and Magnetic Resonance Imaging Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Diagnostic
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 Start Date : March 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. SPECT and MRI differential imaging [ Time Frame: Visit 1 ]

Secondary Outcome Measures :
  1. Neuropsychological analysis [ Time Frame: Visit 1 ]

Eligibility Criteria
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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820937


Locations
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France
Département de Gérontologie - Chu Limoges
Limoges, France, 87000
Pôle de psychiatrie du sujet âgé - CH Esquirol
Limoges, France, 87000
Service de Neurologie - CHU de Limoges
Limoges, France, 87000
Sponsors and Collaborators
University Hospital, Limoges
More Information
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Responsible Party: Marie SENGELEN, CHU Limoges
ClinicalTrials.gov Identifier: NCT00820937    
Other Study ID Numbers: I04014
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: August 27, 2009
Last Verified: August 2009
Additional relevant MeSH terms:
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Dementia
Lewy Body Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
 Mental Disorders
Neurodegenerative Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Synucleinopathies