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

Recruitingn/aAges 40 Years - 99 YearsAllCND Life Sciences
NCT07217054 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

1 site
Digestive Disease Associates
Branford, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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