NCT07217054Recruiting
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
Source: ClinicalTrials.gov · Last updated 11 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 11 Oct 2025
- Start date
- 4 Nov 2025
- Primary completion date
- Oct 2028
- Lead sponsor
- CND Life Sciences
- Diseases
- Parkinson disease
- NCT number
- NCT07217054
What you commit to
- Study type: Observational
- Planned participants: 40
- From 4 Nov 2025 to the primary completion date, Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent intrabdominal surgery
Other illness
- Under active treatment for colon cancer; 30-day post anti-cancer treatment allowed
- Current, ongoing gastrointestinal illness
- Significant cognitive impairment, as determined by study investigators
Other
- Use of anticoagulants (Plavix or aspirin alone is allowed)
- Pregnant or planning to become pregnant before the scheduled colonoscopy
Who the study is looking for
- Relatively healthy men and women ≥40-99 years of age
- Patients with a diagnosis of
- Clinically confirmed PD or
- Clinically confirmed RBD with no diagnosis of PD, DLB or MSA
- 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
Age in the registry: 40 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Digestive Disease Associates Coordinator of this site? Confirm its status | Branford | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.