Study of the Enteric Nervous System Using Colonic Biopsies in Parkinson Patients With LRRK2 Mutation

NCT01618383 | Terminated DMC

• 1 other identifier: RC11_0110
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; gut; colon; biopsies; LRRK2

Outcome Measures

Primary Outcomes (1)

• Presence of alpha-synuclein aggregates in colonic biopsies using immunohistochemistry

  3 months

Secondary Outcomes (1)

• Analysis of intestinal permeability in biopsies using Ussing's chambers

  3 months

Study Arms (1)

Colonic biopsies

OTHER

Colonic biopsies obtained during the course of colonoscopy or rectosigmoidoscopy

Other: colonoscopy or rectosigmoidoscopy

Interventions

colonoscopy or rectosigmoidoscopy OTHER

Usual procedure

Colonic biopsies

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

University Hospital

Nantes, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Tiphaine ROUAUD, Doctor

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: June 13, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 1, 2016

Record last verified: 2016-11

Locations

FR (1)