Detecting Parkinson's-related alpha-synuclein in colon tissue taken during routine colonoscopy
Official title: Detection of Phosphorylated Alpha-Synuclein in Colonic Tissue Biopsy During Routine Colonoscopy
Run by CND Life Sciences · NCT07217054 · Data updated 2026-11-12
This will see if small extra colon tissue samples taken during a routine colonoscopy can find phosphorylated alpha-synuclein in people with Parkinson's disease or REM sleep behavior disorder.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 40 Years to 99 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | CND Life Sciences Academic / other |
| Locations | 1 site (Branford, Connecticut) |
| Status | Recruiting |
| Started | November 4, 2025 |
| Main results expected | October 2028 |
| Study ends | October 2029 |
| Registry record updated | February 11, 2026 |
| Trial ID | NCT07217054 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 40–99 who are relatively healthy, have a clinical diagnosis of Parkinson's disease or RBD (without a diagnosis of PD, DLB, or MSA for the RBD group), and are already scheduled for a routine colonoscopy are ideal candidates.
✕Probably not a fit
People who do not have Parkinson's or RBD, those on disallowed anticoagulants, with active gastrointestinal illness, recent intra-abdominal surgery, pregnant or planning pregnancy, or with significant cognitive impairment are not eligible and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study asks whether phosphorylated alpha-synuclein can be detected in colonic tissue from adults with clinically confirmed Parkinson's disease or REM sleep behavior disorder. Eligible participants aged 40–99 who are already scheduled for a routine colonoscopy will have four additional small biopsy samples taken (two from each side of the colon), adding about two minutes to the procedure. The extra samples will be analyzed in the lab for phosphorylated alpha-synuclein; no additional clinic visits are required and individual test results are not routinely returned to participants. The aim is to determine whether gut biopsy detection could allow earlier identification of disease than symptom-based diagnosis.
Why it matters
Potential benefit: If successful, this approach could allow earlier detection of Parkinson's disease or RBD by finding disease-related protein in the gut, potentially enabling earlier medical management or enrollment in preventive studies.
How similar studies have gone: Prior research has explored alpha-synuclein detection in gut biopsies with mixed results, so the approach is promising but not yet conclusively validated.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Digestive Disease Associates
Branford, Connecticut, United States Recruiting
Study contacts
- Study coordinator: Christina Wagner
- Email: cwagner@ddabranford.com
- Phone: 203-481-0315
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.