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Trial record 3 of 12 for:    LRRK2
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Study of the Enteric Nervous System Using Colonic Biopsies in Parkinson Patients With LRRK2 Mutation (EnteroLarc)

This study is currently recruiting participants.
Verified June 2012 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01618383
First received: June 11, 2012
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

The clinical and pathological similarities between LRRK2 related parkinsonism and idiopathic Parkinson's disease (PD) indicate that monogenetic LRRK2 parkinsonism may be a paradigm for the development of Lewy bodies disease, and a careful look at discrepancies between these two conditions may provide insight into the pathogenesis of PD. The early involvement of the enteric nervous system (ENS) during PD led to theories that an as yet unidentified external agent entering the ENS causes PD . If lesions of the ENS are found in patients who present with a genetic form of parkinsonism would go against this notion, and thus provide insight to the pathophysiology of the disease.


Condition Intervention
Parkinson's Disease
 Other: colonoscopy or rectosigmoidoscopy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Study of the Enteric Nervous System Using Colonic Biopsies in Parkinson Patients With LRRK2 Mutation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Presence of alpha-synuclein aggregates in colonic biopsies using immunohistochemistry [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analysis of intestinal permeability in biopsies using Ussing's chambers [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Colonic biopsies
Colonic biopsies obtained during the course of colonoscopy or rectosigmoidoscopy
 Other: colonoscopy or rectosigmoidoscopy
Usual procedure

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 30-80, both genders
  • Parkinson's disease patients
  • Parkinson's disease patients with G2019S mutations
  • Controls: patient at risk of colic cancer for whom a coloscopy is required
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618383

Contacts
Contact: Thiphaine ROUAUD, Doctor +33 240165199 tiphaine.rouaud@chu-nantes.fr

Locations
France
University Hospital Recruiting
Nantes, France
Contact: Tiphaine ROUAUD, Doctor         tiphaine.rouaud@chu-nantes.fr    
Contact: Pascal DERKINDEREN, Professor         pascal.derkinderen@chu-nantes.fr    
Principal Investigator: Tiphaine ROUAUD, Doctor            
Sub-Investigator: Pascal DERKINDEREN, Professor            
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Tiphaine ROUAUD, Doctor Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01618383     History of Changes
Other Study ID Numbers: RC11_0110
Study First Received: June 11, 2012
Last Updated: June 12, 2012
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Nantes University Hospital:
Parkinson's disease
gut
colon
biopsies
LRRK2

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on June 17, 2013