Lewy Body DementiaDatScanNCT00820937
Diagnostic of Lewy Body Dementia by Combining Scintigraphy (SPECT) Using a Specific Transporter and Magnetic Resonance Imaging (MRI)
A study testing Single photon emission computed tomography and Magnetic Resonance Imaging in people with Lewy Body Dementia, run by University Hospital, Limoges at 3 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Lewy Body Dementia
- What is being tested?
- Single photon emission computed tomography and Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 3 sitesFrance
- Study dates
- Mar 2006to Mar 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Département de Gérontologie - Chu Limoges
Limoges, 87000
Pôle de psychiatrie du sujet âgé - CH Esquirol
Limoges, 87000
Service de Neurologie - CHU de Limoges
Limoges, 87000
About this study
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
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).
Read the 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.
- Conditions
- Lewy Body Dementia
- Being tested
- Single photon emission computed tomography and Magnetic Resonance Imaging
- Medical subject headings
- Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single photon emission computed tomography and Magnetic Resonance ImagingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
SPECT and MRI differential imaging
Measured: Visit 1
Secondary outcomes (1)
Neuropsychological analysis
Measured: Visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startMar 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lewy Body DementiaStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820937
- Sponsor's protocol ID
- I04014
- Acronym
- DatScan
- Status last verified
- Aug 2009
- First submitted
- 27 Dec 2008
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Comparison of DAT-scan evaluation for the aetiological diagnosis of hallucinations in the elderly P. Thomas a,∗,d, A. Prado-Jeana,b, J.-P. Clément a,d, P. Couratier a,b, J. Monteil c NPG Neurologie - Psychiatrie - Gériatrie Volume 13, Issue 75, June 2013, Pages 145-151
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00820937
- Acronym / sponsor ID
- DatScan / I04014
- Conditions
- Lewy Body Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 12 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single photon emission computed tomography and Magnetic Resonance Imaging | Procedure or surgery | – |
Primary outcome
SPECT and MRI differential imaging
Time frame: Visit 1
1 secondary outcome
Neuropsychological analysis
Time frame: Visit 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Results publicationComparison of DAT-scan evaluation for the aetiological diagnosis of hallucinations in the elderly P. Thomas a,∗,d, A. Prado-Jeana,b, J.-P. Clément a,d, P. Couratier a,b, J. Monteil c NPG Neurologie - Psychiatrie - Gériatrie Volume 13, Issue 75, June 2013, Pages 145-151
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single photon emission computed tomography and Magnetic Resonance Imaging in people with Lewy Body Dementia, run by University Hospital, Limoges at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SPECT and MRI differential imaging (time frame: Visit 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00820937, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.