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

NCT07217054 | Recruiting

• 1 other identifier: CND-107
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PARKINSON DISEASE (Disorder); Parkinson; Parkinson s Disease; Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Detection of phosphorylated alpha-synuclein in colon tissue samples

  At time of colonoscopy procedure

Study Arms (2)

Parkinson's Disease (PD)

Trial participants with Parkinson's disease

REM Sleep Behavior Disorder (RBD)

Trial participants with REM Sleep Behavior Disorder (RBD)

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

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

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

Sponsors & Collaborators

• CND Life Sciences: lead

Study Sites (1)

Digestive Disease Associates

Branford, Connecticut, 06405, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Christina Wagner

CONTACT

203-481-0315; cwagner@ddabranford.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2025
• First Posted: October 15, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

US (1)