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

RECRUITINGSponsored by CND Life Sciences
Actively Recruiting
SponsorCND Life Sciences
Started2025-11-04
Est. completion2028-10
Eligibility
Age40 Years – 99 Years
Healthy vol.Accepted
Locations1 site

Summary

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.

Eligibility

Age: 40 Years – 99 YearsHealthy volunteers accepted
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

Conditions4

PARKINSON DISEASE (Disorder)ParkinsonParkinson DiseaseParkinson's Disease

Locations1 site

Digestive Disease Associates
Branford, Connecticut, 06405
Christina Wagner203-481-0315cwagner@ddabranford.com

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