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

Detection of Phosphorylated Alpha-Synuclein in Colonic Tissue Biopsy During Routine Colonoscopy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 99 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether small tissue samples taken during a routine colonoscopy can show a protein called alpha-synuclein. Researchers want to learn if this could help detect Parkinson's disease or REM sleep behavior disorder (RBD), a sleep problem where muscles do not stay relaxed during dream sleep. The study is for adults ages 40–99 with either condition who have agreed to a routine colonoscopy.

The goal of this observational study is to learn whether tissue samples taken from the colon during routine colonoscopy can detect signs of Parkinson's disease or REM Sleep Behavior Disorder (RBD). The main question it aims to answer is: Can doctors find a protein called alpha-synuclein in colon tissue samples from people with Parkinson's disease and RBD? Currently, Parkinson's disease is diagnosed by observing symptoms like tremors and movement problems and RBD by loss of muscle atonia during REM sleep, but by then the disease has already progressed significantly. Earlier detection could help doctors start treatment sooner.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 40–99 and relatively healthy.
  • A doctor has confirmed that you have Parkinson's disease or RBD.
  • If you have RBD, you must not have Parkinson's disease, dementia with Lewy bodies (DLB), or multiple system atrophy (MSA). DLB and MSA are brain and nerve diseases.
  • You have agreed to a routine colonoscopy, an exam inside the colon, to check for colon cancer or rule out other digestive diseases.

Who can't join

  • You take medicines that prevent blood clots. Plavix or aspirin alone is allowed.
  • You are getting treatment for colon cancer. You may join 30 days after cancer treatment.
  • You currently have an ongoing digestive illness.
  • You recently had surgery inside your belly.
  • You are pregnant or plan to become pregnant before the colonoscopy.
  • The study team finds that you have serious problems with memory or thinking.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Relatively healthy men and women ≥40-99 years of age 2. Patients with a diagnosis of 1. Clinically confirmed PD or 2. Clinically confirmed RBD with no diagnosis of PD, DLB or MSA 3. Patients must have agreed to undergo a routine colonoscopy as part of their screening or surveillance for colon cancer or for diagnostic purposes for the exclusion of other GI diseases Exclusion Criteria: 1. Use of anticoagulants (Plavix or aspirin alone is allowed) 2. Under active treatment for colon cancer; 30-day post anti-cancer treatment allowed 3. Current, ongoing gastrointestinal illness 4. Recent intrabdominal surgery 5. Pregnant or planning to become pregnant before the scheduled colonoscopy 6. Significant cognitive impairment, as determined by study investigators

Study sites (1)

CT