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

NCT00917709 | Completed

• 1 other identifier: CHUBX 2008/34
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dementia With Lewy Bodies

Keywords

dementia with Lewy bodies; imaging; acetylcholine; dopamine; IBVM; DATSCAN

Outcome Measures

Primary Outcomes (1)

• Binding Potential (BP) quantification of each radioligand

  Day 1 ; Day 1 and between day 14 to 28

Secondary Outcomes (1)

• Ratio dopaminergic system/cholinergic system Binding Potential

  Day 1 and between day 14 to 28

Study Arms (3)

DLB with extrapyramidal syndrome

EXPERIMENTAL

patients dementia with Lewy bodies with extrapyramidal syndrome

Other: Imaging with IBVM; Other: Imaging with DATSCAN; Behavioral: neuropsychological evaluation

DLB without extrapyramidal syndrome

OTHER

patients dementia with Lewy bodies without extrapyramidal syndrome

Other: Imaging with IBVM; Other: Imaging with DATSCAN; Behavioral: neuropsychological evaluation

healthy volunteers

SHAM COMPARATOR

healthy volunteers

Other: Imaging with IBVM; Other: Imaging with DATSCAN; Behavioral: neuropsychological evaluation

Interventions

Imaging with IBVM OTHER

in vivo molecular imaging of presynaptic molecular target of cholinergic systems with \[123I\]-iodobenzovesamicol

DLB with extrapyramidal syndrome; DLB without extrapyramidal syndrome; healthy volunteers

Imaging with DATSCAN OTHER

in vivo molecular imaging of presynaptic molecular target of dopaminergic systems (DAT) with DATSCAN

DLB with extrapyramidal syndrome; DLB without extrapyramidal syndrome; healthy volunteers

neuropsychological evaluation BEHAVIORAL

neuropsychological evaluation using neuropsychological tests

DLB with extrapyramidal syndrome; DLB without extrapyramidal syndrome; healthy volunteers

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients: man or woman probable DLB, with and without extrapyramida syndrome
• Healthy subjects: man or woman with no neuropsychiatric disorders

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Groupe Hospitalier Pellegrin - C.H.U. de Bordeaux

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Lewy Body Disease

Interventions

X-Rays; ioflupane

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Michèle ALLARD, Pr

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2009
• First Posted: June 10, 2009
• Study Start: May 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: August 21, 2014

Record last verified: 2014-08

Locations

FR (1)