Imaging of Vesicular Acetylcholine and Dopamine Transporters in Dementia With Lewy Bodies (IBVM/DATSCAN)

This study is currently recruiting participants.
Verified November 2013 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00917709
First received: June 5, 2009
Last updated: November 18, 2013
Last verified: November 2013
  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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Binding Potential (BP) quantification of each radioligand [ Time Frame: Day 1 ; Day 1 and between day 14 to 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ratio dopaminergic system/cholinergic system Binding Potential [ Time Frame: Day 1 and between day 14 to 28 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2009
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00917709

Contacts
Contact: Michèle ALLARD, Pr michele.allard@chu-bordeaux.fr
Contact: Joachim MAZERE, Dr joachim.mazere@chu-bordeaux.fr

Locations
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         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Michèle ALLARD, Pr University Hospital, Bordeaux
  More Information

No publications provided

Responsible Party: 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: November 18, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
dementia with Lewy bodies
imaging
acetylcholine
dopamine
IBVM
DATSCAN

Additional relevant MeSH terms:
Lewy Body Disease
Dementia
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

ClinicalTrials.gov processed this record on April 21, 2014