Parkinson's Disease Biomarkers in Nerve Cells in the Gut

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT05347407
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Colonoscopy — PROCEDURE
    Patients will be provided with a kit and be asked to bring a stool sample to their colonoscopy appointment. Mucosal biopsies will be collected with standard forceps during colonoscopy. If the physician determines that the patient will need colonoscopy with biopsy as part of their routine clinical care, they will take 6-8 additional biopsies for use in the research study. If the physician determines that the patient will need colonoscopy without biopsy as part of their routine clinical care, they will take 6-8 biopsies for use in the research study only. The collection of additional biopsies will add an estimated two minutes to the whole procedure.

Study Details

Parkinson's disease affects all the nerve cells in the body, including the ones in the gut. The gut contains its own nervous system, the enteric nervous system, and can be thought of as a "second brain". This second brain can reflect what is going on in the actual brain. This study is being done to look for biomarkers, or early indicators of developing Parkinson's disease, in the microbiome and in the gut tissue taken during routine screening colonoscopy. People aged 45 and over who are due for their routine screening colonoscopy are eligible to participate.

Key Dates

Start date
Dec 30, 2020
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Control
    Healthy Patients
  • Arm: Parkinson's Disease
    Patients diagnosed with Parkinson's disease
  • Arm: At risk for PD
    Defined as REM sleep behavior disorder, known genetic risk factor, and/or first degree relatives with PD
  • Arm: Dementia with Lewy Bodies
    Patients diagnosed with Dementia with Lewy Body Disease
  • Arm: Multiple System Atrophy
    Patients diagnosed with Multiple System Atrophy

Primary Outcome Measure

Biochemical changes in enteric nervous system [ Time Frame: A single timepoint will be evaluated on biopsy samples taken from subjects during routine screening colonoscopy. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10021
Virginia Gao, MD PhD
[email protected]
929-989-7898
Jacqueline Burre, PhD
[email protected]
Virginia Gao, M.D. PhD (PRINCIPAL_INVESTIGATOR)
Jacqueline Burre, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Weill Cornell Medicine· New York, NY

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