RECRUITINGOBSERVATIONAL
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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
Who Should NOT Join This Trial:
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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Locations (1)
Digestive Disease Associates
Branford, Connecticut, United States