Imaging of Vesicular Acetylcholine and Dopamine Transporters in Dementia With Lewy Bodies

Dementia With Lewy Bodies Clinical Trial

— IBVM/DATSCAN  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00917709
• Other study ID #: CHUBX 2008/34
• Status: Completed
• Phase: N/A
• First received: June 5, 2009
• Last updated: August 20, 2014
• Start date: May 2009
• Est. completion date: October 2013

Study information

• Verified date: August 2014
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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).

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Dementia
• Dementia With Lewy Bodies
• Lewy Body Disease

Intervention

Other:
• Imaging with IBVM
in vivo molecular imaging of presynaptic molecular target of cholinergic systems with [123I]-iodobenzovesamicol
• 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

Locations

Country	Name	City	State
France	Groupe Hospitalier Pellegrin - C.H.U. de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binding Potential (BP) quantification of each radioligand		Day 1 ; Day 1 and between day 14 to 28	No
Secondary	Ratio dopaminergic system/cholinergic system Binding Potential		Day 1 and between day 14 to 28	No