Dementia With Lewy BodiesIBVM/DATSCANNCT00917709
Imaging of Vesicular Acetylcholine and Dopamine Transporters in Dementia With Lewy Bodies
A study testing Imaging with IBVM, Imaging with DATSCAN and neuropsychological evaluation in people with Dementia With Lewy Bodies, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The general aim of this research project is to determine the relationships between alterations of central cholinergic (ACh) and dopaminergic (DA) systems and neurobehavioral features of dementias with Lewy bodies (DLB). Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia With Lewy Bodies
- What is being tested?
- Imaging with IBVM, Imaging with DATSCAN and neuropsychological evaluation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- May 2009to Oct 2013
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients: man or woman probable DLB, with and without extrapyramida syndrome
- Healthy subjects: man or woman with no neuropsychiatric disorders
Who cannot join
- Diagnostic or therapeutic irradiation during the 12 months before SPECT imaging
- Age less than 18 and more than 90
- Iodine sensibility
- Brain-vascular disease, severe brain injury, type I and II diabetes mellitus, thyroid dysfunction, chronic alcoholism
- Pregnant and breast feeding women, women in age to procreate
- Impossibility to undergo MRI study (pace-maker, claustrophobia)
- Persons under guardianship, outside state to express their assent or in emergency situation
- Healthy subjects: cognitive impairment, dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Vivo SPECT Imaging of Vesicular Acetylcholine and Dopamine Transporters in Dementia With Lewy Bodies: Applying in Diagnostic and Identification of Pathological Subtypes.
The general aim of this research project is to determine the relationships between alterations of central cholinergic (ACh) and dopaminergic (DA) systems and neurobehavioral features of dementias with Lewy bodies (DLB).
Both clinical and neurochemical data support the view that DLB is not a homogeneous entity and it can be hypothesized that differential alterations of central ACh systems (i.e. anterior vs posterior vs striatal interneurons) in association or not with a DA nigrostriatal dysfunction could partly support the clinical heterogeneity observed in this disease. ACh in vivo imaging has been relatively underutilized to date and to our knowledge only on the postsynaptic side. Furthermore, ACh/DA interactions and their relationships with the symptomatology of DLB and related pathologies (PDD) had never been investigated.
Read the detailed description
Neurochemical investigations and observations suggest a crucial physiopathological role of central ACh systems in dementias with Lewy bodies (DLB). Alterations of cholinergic neurons could be involved in the general cognitive decline (central feature) but also in fluctuating attentional performances and rapid eye movement sleep disorder as it was shown in thalamus.
Post synaptic in vivo SPECT imaging recently demonstrated an increase in muscarinic receptors in DLB patients in the occipital cortex that could be associated with the visuospatial dysfunction often reported in DLB or even in visual hallucinations.From a pharmacological point of view, the involvement of ACh systems in DLB is confirmed by the consistently reported efficacy of cholinesterase inhibitor therapy, considered as greater than in AD.
Concerning DA systems, presynaptic in vivo SPECT imaging studies of DA transporter have shown a decreased striatal uptake in DLB patients, different when compared with Parkinson's disease patients or Alzheimer's disease patients.
Strategy, procedure In this project we will use for the first time in vivo molecular imaging of presynaptic molecular target of ACh systems (VAChT) with [123I]-iodobenzovesamicol and of DA systems (DAT) with DATSCAN in order to better analyse the link between neurobehavioral profiles of patients and a differential alteration of ACh/DA systems in DLB.
- Conditions
- Dementia With Lewy Bodies
- Being tested
- Imaging with IBVM, Imaging with DATSCAN, neuropsychological evaluation
- Keywords
- dementia with Lewy bodies, imaging, acetylcholine, dopamine, IBVM, DATSCAN
- 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.
Imaging with IBVMOther
in vivo molecular imaging of presynaptic molecular target of cholinergic systems with [123I]-iodobenzovesamicol
Imaging with DATSCANOther
in vivo molecular imaging of presynaptic molecular target of dopaminergic systems (DAT) with DATSCAN
neuropsychological evaluationBehavioural
neuropsychological evaluation using neuropsychological tests
| Study group | Role | What they receive |
|---|---|---|
| DLB with extrapyramidal syndrome | Experimental | patients dementia with Lewy bodies with extrapyramidal syndrome Receives: Other: Imaging with IBVM; Other: Imaging with DATSCAN; Behavioral: neuropsychological evaluation |
| DLB without extrapyramidal syndrome | Other | patients dementia with Lewy bodies without extrapyramidal syndrome Receives: Other: Imaging with IBVM; Other: Imaging with DATSCAN; Behavioral: neuropsychological evaluation |
| healthy volunteers | Sham comparator | healthy volunteers Receives: Other: Imaging with IBVM; Other: Imaging with DATSCAN; Behavioral: neuropsychological evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binding Potential (BP) quantification of each radioligand
Measured: Day 1 ; Day 1 and between day 14 to 28
Secondary outcomes (1)
Ratio dopaminergic system/cholinergic system Binding Potential
Measured: Day 1 and between day 14 to 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2013
- Study completionOct 2013
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 Dementia With Lewy BodiesStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michèle ALLARD, Pr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917709
- Sponsor's protocol ID
- CHUBX 2008/34
- Acronym
- IBVM/DATSCAN
- Status last verified
- Aug 2014
- First submitted
- 5 Jun 2009
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Mazere J, Lamare F, Allard M, Fernandez P, Mayo W. 123I-Iodobenzovesamicol SPECT Imaging of Cholinergic Systems in Dementia with Lewy Bodies. J Nucl Med. 2017 Jan;58(1):123-128. doi: 10.2967/jnumed.116.176180. Epub 2016 Jul 28.
PubMed 27469360
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo SPECT Imaging of Vesicular Acetylcholine and Dopamine Transporters in Dementia With Lewy Bodies: Applying in Diagnostic and Identification of Pathological Subtypes.
- ClinicalTrials.gov ID
- NCT00917709
- Acronym / sponsor ID
- IBVM/DATSCAN / CHUBX 2008/34
- Conditions
- Dementia With Lewy Bodies
- Keywords
- dementia with Lewy bodies, imaging, acetylcholine, dopamine, IBVM, DATSCAN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 10 Jun 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 general aim of this research project is to determine the relationships between alterations of central cholinergic (ACh) and dopaminergic (DA) systems and neurobehavioral features of dementias with Lewy bodies (DLB).
Both clinical and neurochemical data support the view that DLB is not a homogeneous entity and it can be hypothesized that differential alterations of central ACh systems (i.e. anterior vs posterior vs striatal interneurons) in association or not with a DA nigrostriatal dysfunction could partly support the clinical heterogeneity observed in this disease. ACh in vivo imaging has been relatively underutilized to date and to our knowledge only on the postsynaptic side. Furthermore, ACh/DA interactions and their relationships with the symptomatology of DLB and related pathologies (PDD) had never been investigated.
Detailed description
Neurochemical investigations and observations suggest a crucial physiopathological role of central ACh systems in dementias with Lewy bodies (DLB). Alterations of cholinergic neurons could be involved in the general cognitive decline (central feature) but also in fluctuating attentional performances and rapid eye movement sleep disorder as it was shown in thalamus.
Post synaptic in vivo SPECT imaging recently demonstrated an increase in muscarinic receptors in DLB patients in the occipital cortex that could be associated with the visuospatial dysfunction often reported in DLB or even in visual hallucinations.From a pharmacological point of view, the involvement of ACh systems in DLB is confirmed by the consistently reported efficacy of cholinesterase inhibitor therapy, considered as greater than in AD.
Concerning DA systems, presynaptic in vivo SPECT imaging studies of DA transporter have shown a decreased striatal uptake in DLB patients, different when compared with Parkinson's disease patients or Alzheimer's disease patients.
Strategy, procedure In this project we will use for the first time in vivo molecular imaging of presynaptic molecular target of ACh systems (VAChT) with [123I]-iodobenzovesamicol and of DA systems (DAT) with DATSCAN in order to better analyse the link between neurobehavioral profiles of patients and a differential alteration of ACh/DA systems in DLB.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DLB with extrapyramidal syndrome | Experimental | Other: Imaging with IBVM, Other: Imaging with DATSCAN, Behavioral: neuropsychological evaluationpatients dementia with Lewy bodies with extrapyramidal syndrome |
| DLB without extrapyramidal syndrome | Other | Other: Imaging with IBVM, Other: Imaging with DATSCAN, Behavioral: neuropsychological evaluationpatients dementia with Lewy bodies without extrapyramidal syndrome |
| healthy volunteers | Sham comparator | Other: Imaging with IBVM, Other: Imaging with DATSCAN, Behavioral: neuropsychological evaluationhealthy volunteers |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients: man or woman probable DLB, with and without extrapyramida syndrome
- Healthy subjects: man or woman with no neuropsychiatric disorders
Key exclusion criteria (8 listed)
- Diagnostic or therapeutic irradiation during the 12 months before SPECT imaging
- Age less than 18 and more than 90
- Iodine sensibility
- Brain-vascular disease, severe brain injury, type I and II diabetes mellitus, thyroid dysfunction, chronic alcoholism
- Pregnant and breast feeding women, women in age to procreate
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 |
|---|---|---|
| Imaging with IBVMin vivo molecular imaging of presynaptic molecular target of cholinergic systems with [123I]-iodobenzovesamicol | Other | DLB with extrapyramidal syndrome, DLB without extrapyramidal syndrome, healthy volunteers |
| Imaging with DATSCANin vivo molecular imaging of presynaptic molecular target of dopaminergic systems (DAT) with DATSCAN | Other | DLB with extrapyramidal syndrome, DLB without extrapyramidal syndrome, healthy volunteers |
| neuropsychological evaluationneuropsychological evaluation using neuropsychological tests | Behavioural | DLB with extrapyramidal syndrome, DLB without extrapyramidal syndrome, healthy volunteers |
Primary outcome
Binding Potential (BP) quantification of each radioligand
Time frame: Day 1 ; Day 1 and between day 14 to 28
1 secondary outcome
Ratio dopaminergic system/cholinergic system Binding Potential
Time frame: Day 1 and between day 14 to 28
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 14 May 2026.
- Results publication: PubMed 27469360Mazere J, Lamare F, Allard M, Fernandez P, Mayo W. 123I-Iodobenzovesamicol SPECT Imaging of Cholinergic Systems in Dementia with Lewy Bodies. J Nucl Med. 2017 Jan;58(1):123-128. doi: 10.2967/jnumed.116.176180. Epub 2016 Jul 28.
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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.
Michèle ALLARD, Pr principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaging with IBVM, Imaging with DATSCAN and neuropsychological evaluation in people with Dementia With Lewy Bodies, run by University Hospital, Bordeaux at 1 site 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 2 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 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Binding Potential (BP) quantification of each radioligand (time frame: Day 1 ; Day 1 and between day 14 to 28). 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 NCT00917709, 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 14 May 2026.