Biochemical characterization of Parkinson's disease-related proteins in the enteric nervous system

Clinical Trial Details

Parkinson's disease affects 1 in 100 people over the age of 65, but the time between Parkinson's disease onset and diagnosis can be many months or years. Interestingly, pathological hallmarks of Parkinson's in the brain can also be seen in the neurons in the gut and symptoms like constipation often precede the onset of tremor and incoordination by many years. It is now believed that Parkinson's disease may begin in the gut, at least in some people. Unlike the neurons in the brain, the neurons in the gut are accessible through routine colonoscopy, and so can be obtained by biopsy to study in the laboratory. In addition, there are links between gut microbes, including bacteria, and the diagnosis of Parkinson's disease. This research study is therefore being done to discover whether the pathology and types of bacteria in the gut can serve as an indicator of Parkinson's disease in subjects aged 45-75 that could eventually help in earlier diagnosis. It will also strengthen our understanding of the link between the gut and brain in Parkinson's disease.

Key Eligibility:

Experimental Cohort
Inclusion Criteria

Age 45-75 years old
Idiopathic Parkinson’s Disease defined by the modified UK Parkinson’s Disease Society Brain Bank criteria
Baseline Hoehn & Yahr score 1-4
Able to give informed consent for study participation

Exclusion Criteria

Clinical features suggestive of a neurodegenerative diagnosis other than Parkinson’s disease
Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis or other neurodegenerative diseases
Significant concomitant medical disease limiting life expectancy to less than 24 months from study inclusion, or significant and serious concomitant medical disease that is poorly controlled
Active or untreated gastrointestinal disease

Control Cohort
Inclusion Criteria

Age 45-75 years old
No contraindications to undergoing screening colonoscopy
Able to give informed consent for study participation

Exclusion Criteria

Clinical features suggestive of a Parkinson’s disease or another neurodegenerative diagnosis
Significant concomitant medical disease limiting life expectancy to less than 24 months from study inclusion, or significant and serious concomitant medical disease that is poorly controlled
Signs of active malignant disease or other clinically relevant abnormality on chest x-ray
Active or untreated gastrointestinal disease

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Virginia Gao, MD, PhD
(347) 610-3475
vig9070@med.cornell.edu

Primary Investigator(s)

Virginia Gao, MD, PhD

Jacqueline Burre, PhD

Protocol ID(s)

Weill Cornell Medicine IRB #:

1909020813

Status

Open to Enrollment

Age Group

Adult

Disease

Parkinson's Disease