- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00917709
Imaging of Vesicular Acetylcholine and Dopamine Transporters in Dementia With Lewy Bodies (IBVM/DATSCAN)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bordeaux, France, 33076
- Groupe Hospitalier Pellegrin - C.H.U. de Bordeaux
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients: man or woman probable DLB, with and without extrapyramida syndrome
- Healthy subjects: man or woman with no neuropsychiatric disorders
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: DLB with extrapyramidal syndrome
patients dementia with Lewy bodies with extrapyramidal syndrome
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in vivo molecular imaging of presynaptic molecular target of cholinergic systems with [123I]-iodobenzovesamicol
in vivo molecular imaging of presynaptic molecular target of dopaminergic systems (DAT) with DATSCAN
neuropsychological evaluation using neuropsychological tests
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Other: DLB without extrapyramidal syndrome
patients dementia with Lewy bodies without extrapyramidal syndrome
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in vivo molecular imaging of presynaptic molecular target of cholinergic systems with [123I]-iodobenzovesamicol
in vivo molecular imaging of presynaptic molecular target of dopaminergic systems (DAT) with DATSCAN
neuropsychological evaluation using neuropsychological tests
|
Sham Comparator: healthy volunteers
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in vivo molecular imaging of presynaptic molecular target of cholinergic systems with [123I]-iodobenzovesamicol
in vivo molecular imaging of presynaptic molecular target of dopaminergic systems (DAT) with DATSCAN
neuropsychological evaluation using neuropsychological tests
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Binding Potential (BP) quantification of each radioligand
Time Frame: Day 1 ; Day 1 and between day 14 to 28
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Day 1 ; Day 1 and between day 14 to 28
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ratio dopaminergic system/cholinergic system Binding Potential
Time Frame: Day 1 and between day 14 to 28
|
Day 1 and between day 14 to 28
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2008/34
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Eisai Co., Ltd.CompletedDementia With Lewy Bodies (DLB)
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Eisai Co., Ltd.CompletedDementia With Lewy Bodies (DLB)Japan
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