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| Sponsor: | University Hospital, Bordeaux |
|---|---|
| Information provided by: | University Hospital, Bordeaux |
| ClinicalTrials.gov Identifier: | NCT00917709 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Dementia With Lewy Bodies |
Other: Imaging with IBVM Other: Imaging with DATSCAN Behavioral: neuropsychological evaluation |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
| 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. |
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: DLB with extrapyramidal syndrome
patients dementia with Lewy bodies with extrapyramidal syndrome
|
Other: Imaging with IBVM
in vivo molecular imaging of presynaptic molecular target of cholinergic systems with [123I]-iodobenzovesamicol
Other: Imaging with DATSCAN
in vivo molecular imaging of presynaptic molecular target of dopaminergic systems (DAT) with DATSCAN
Behavioral: neuropsychological evaluation
neuropsychological evaluation using neuropsychological tests
|
|
DLB without extrapyramidal syndrome
patients dementia with Lewy bodies without extrapyramidal syndrome
|
Other: Imaging with IBVM
in vivo molecular imaging of presynaptic molecular target of cholinergic systems with [123I]-iodobenzovesamicol
Other: Imaging with DATSCAN
in vivo molecular imaging of presynaptic molecular target of dopaminergic systems (DAT) with DATSCAN
Behavioral: neuropsychological evaluation
neuropsychological evaluation using neuropsychological tests
|
|
Sham Comparator: healthy volunteers
healthy volunteers
|
Other: Imaging with IBVM
in vivo molecular imaging of presynaptic molecular target of cholinergic systems with [123I]-iodobenzovesamicol
Other: Imaging with DATSCAN
in vivo molecular imaging of presynaptic molecular target of dopaminergic systems (DAT) with DATSCAN
Behavioral: neuropsychological evaluation
neuropsychological evaluation using neuropsychological tests
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Michèle ALLARD, Pr | michele.allard@chu-bordeaux.fr | |
| Contact: Joachim MAZERE, Dr | joachim.mazere@chu-bordeaux.fr |
| France | |
| Groupe Hospitalier Pellegrin - C.H.U. de Bordeaux | Recruiting |
| Bordeaux, France, 33076 | |
| Contact: Michèle ALLARD michele.allard@chu-bordeaux.fr | |
| Contact: Willy MAYO willy.mayo@inserm.fr | |
| Principal Investigator: Michèle ALLARD, Pr | |
| Sub-Investigator: Philippe FERNANDEZ, Pr | |
| Sub-Investigator: Martine GUYOT, Dr | |
| Sub-Investigator: Igor SIBON, Dr | |
| Sub-Investigator: Sophie AURIACOMBE, Dr | |
| Sub-Investigator: Jean-François DARTIGUES, Pr | |
| Sub-Investigator: Jean-Marc ORGOGOZZO, Pr | |
| Sub-Investigator: Stéphane LANUSSE, Dr | |
| Principal Investigator: | Michèle ALLARD, Pr | University Hospital, Bordeaux |
More Information
| Responsible Party: | Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux |
| ClinicalTrials.gov Identifier: | NCT00917709 History of Changes |
| Other Study ID Numbers: | CHUBX 2008/34 |
| Study First Received: | June 5, 2009 |
| Last Updated: | June 10, 2011 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
dementia with Lewy bodies imaging acetylcholine |
dopamine IBVM DATSCAN |
|
Dementia Lewy Body Disease Brain Diseases Central Nervous System Diseases Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Parkinsonian Disorders Basal Ganglia Diseases Movement Disorders Neurodegenerative Diseases Acetylcholine Dopamine Dopamine Agents |
Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cardiotonic Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Protective Agents |
