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

Sponsored by:	University Hospital, Limoges
Information provided by:	University Hospital, Limoges
ClinicalTrials.gov Identifier:	NCT00820937

Purpose

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	Intervention
Lewy Body Dementia	Procedure: Single photon emission computed tomography and Magnetic Resonance Imaging

Genetics Home Reference related topics: Alzheimer disease familial paroxysmal nonkinesigenic dyskinesia

MedlinePlus related topics: Dementia Lewy Body Disease MRI Scans Nuclear Scans

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment
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

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:

SPECT and MRI differential imaging [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Neuropsychological analysis [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	March 2006
Estimated Study Completion Date:	March 2009
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	65 Years to 90 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820937

Locations

France
Pôle de psychiatrie du sujet âgé - CH Esquirol
Limoges, France, 87000
Service de Neurologie - CHU de Limoges
Limoges, France, 87000
Département de Gérontologie - Chu Limoges
Limoges, France, 87000

Sponsors and Collaborators

University Hospital, Limoges

More Information

No publications provided

Responsible Party:	CHU Limoges ( Marie SENGELEN )
Study ID Numbers:	I04014
Study First Received:	December 27, 2008
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00820937 History of Changes
Health Authority:	France: Direction Générale de la Santé

Study placed in the following topic categories:

Lewy Body Dementia
Ganglion Cysts
Alzheimer Disease
Hallucinations
Basal Ganglia Diseases
Central Nervous System Diseases
Neurodegenerative Diseases
Lewy Body Disease

Brain Diseases
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Movement Disorders
Mental Disorders
Parkinsonian Disorders
Dementia
Delirium

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Movement Disorders
Mental Disorders
Basal Ganglia Diseases
Nervous System Diseases
Central Nervous System Diseases

Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases
Lewy Body Disease
Dementia

ClinicalTrials.gov processed this record on May 06, 2009