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

August 20, 2014 updated by: University Hospital, Bordeaux

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

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

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bordeaux, France, 33076
        • Groupe Hospitalier Pellegrin - C.H.U. de Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: DLB with extrapyramidal syndrome
patients dementia with Lewy bodies with extrapyramidal syndrome
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
Other: DLB without extrapyramidal syndrome
patients dementia with Lewy bodies without extrapyramidal syndrome
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
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
Day 1 ; Day 1 and between day 14 to 28

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

June 5, 2009

First Submitted That Met QC Criteria

June 9, 2009

First Posted (Estimate)

June 10, 2009

Study Record Updates

Last Update Posted (Estimate)

August 21, 2014

Last Update Submitted That Met QC Criteria

August 20, 2014

Last Verified

August 1, 2014

More Information

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.

Clinical Trials on Dementia With Lewy Bodies

Clinical Trials on Imaging with IBVM

Subscribe