Actively Recruiting

Age: 40Years - 99Years
All Genders
ID07217054

Detection of Phosphorylated Alpha-Synuclein in Colon Tissue During Routine Colonoscopy for Parkinson's Disease or REM Sleep Behavior Disorder

Led by CND Life Sciences · Updated on 2026-02-11

40

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying whether tissue samples taken from the colon during routine colonoscopies can detect signs of Parkinson's disease or REM Sleep Behavior Disorder (RBD). The study focuses on finding a protein called phosphorylated alpha-synuclein in colon tissue, which may help diagnose these conditions earlier than current methods that rely on symptoms. Early detection could allow doctors to begin treatment sooner when the disease is less advanced. During the routine colonoscopy procedure, doctors will take four small additional tissue samples from the colon (two from each side). This adds only about two minutes to the standard procedure. After the colonoscopy, no extra visits are needed. The collected tissue samples will be tested for the alpha-synuclein protein to evaluate its presence in participants with Parkinson's disease or RBD. Participants will undergo the usual colonoscopy as planned, with the extra tissue sampling included. No individual test results will be given to participants. Researchers will measure the presence of phosphorylated alpha-synuclein in the colon tissue at the time of the procedure. The study involves 40 adults aged 40 to 99 who have Parkinson's disease or RBD and who are already scheduled for routine colonoscopy. The study is sponsored by CND Life Sciences and aims to improve early diagnosis of these neurological conditions.

CONDITIONS

Brief Title

Colonic Tissue Biopsy Detection of Phosphorylated Alpha-synuclein for Parkinson's Diagnosis or REM Sleep Behavior Disorder

Who Can Participate

Age: 40Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 40 to 99 years
  • Diagnosed with clinically confirmed Parkinson's disease or REM Sleep Behavior Disorder without diagnosis of Parkinson's Disease, dementia with Lewy bodies, or multiple system atrophy
  • Scheduled to undergo a routine colonoscopy for screening, surveillance, or diagnostic purposes related to colon cancer or other gastrointestinal diseases
  • Relatively healthy men and women
Not Eligible

You will not qualify if you...

  • Use of anticoagulants other than Plavix or aspirin
  • Currently receiving active treatment for colon cancer (30-day post treatment allowed)
  • Having an ongoing gastrointestinal illness
  • Recent abdominal surgery
  • Pregnant or planning pregnancy before the scheduled colonoscopy
  • Significant cognitive impairment as determined by investigators

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Day of colonoscopy procedure

Participants undergo a routine colonoscopy during which additional small tissue samples from the colon are collected to test for a specific protein linked to Parkinson's disease and REM Sleep Behavior Disorder.

1 visit (in-person) during routine colonoscopy

Long-term Monitoring

Duration - No additional time commitment beyond colonoscopy day

Participants are observed after the colonoscopy with no additional visits required. Tissue samples will be analyzed for research purposes, but participants will not receive individual test results.

No additional visits

Trial Site Locations

Total: 1 location

1

Digestive Disease Associates

Branford, Connecticut, United States, 06405

Actively Recruiting

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Research Team

C

Christina Wagner

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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