Colonic Tissue Biopsy Detection of Phosphorylated Alpha-synuclein for Parkinson's Diagnosis or REM Sleep Behavior Disorder
Recruiting now
Conditions studied: PARKINSON DISEASE (Disorder), Parkinson, Parkinson s Disease, Parkinson Disease
In brief
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.
Key facts
- Study ID
- NCT07217054
- Run by
- CND Life Sciences
- People needed
- 40
- Starts
- 2025-11-04
- Expected to finish
- 2029-10-01
- Last updated by the study team
- 2026-02-11
Who can join
Age: 40 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Use of anticoagulants (Plavix or aspirin alone is allowed)
- Under active treatment for colon cancer; 30-day post anti-cancer treatment allowed
- Current, ongoing gastrointestinal illness
- Recent intrabdominal surgery
- Pregnant or planning to become pregnant before the scheduled colonoscopy
- Significant cognitive impairment, as determined by study investigators
Where it is running
- Digestive Disease Associates — Branford, Connecticut, United States (enrolling)
Full record on ClinicalTrials.gov
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