NCT Number: NCT00820937
Diagnostic of Lewy Body Dementia by Combining Scintigraphy (SPECT) Using a Specific Transporter and Magnetic Resonance Imaging (MRI)
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).
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Notify MeKey information
Conditions
Age range
65 year–90 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Département de Gérontologie - Chu Limoges, Limoges, France
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
SPECT and MRI differential imaging
Time frame: Visit 1
Secondary outcomes
-
Neuropsychological analysis
Time frame: Visit 1
Sponsors and collaborators
Lead sponsor
University Hospital, Limoges
Other
Registry information
Official study 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
Acronym: DatScan
Important dates
- Study start
- 2006
- Primary completion
- 2008
- Study completion
- 2008
- First posted
- Jan 12, 2009
- Registry last updated
- Jul 30, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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