Colonic Tissue Biopsy Detection of Phosphorylated Alpha-synuclein for Parkinson's Diagnosis or REM Sleep Behavior Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-99
SponsorCND Life Sciences
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adults with clinically confirmed Parkinson's disease or REM Sleep Behavior Disorder who are undergoing routine colonoscopies for standard medical care. Participants must be able to provide informed consent and understand that participation is voluntary and for research purposes.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
40 Participants
are grouped into 2 trial groupsGroup A: Parkinson's Disease (PD)
Group B: REM Sleep Behavior Disorder (RBD)
Trial outcomes
Primary outcomes
1
Detection of phosphorylated alpha-synuclein in colon tissue samples
Time frame
At time of colonoscopy procedureSponsors and contacts
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Source ClinicalTrials.gov