Colonoscopic Detection of Phosphorylated Alpha-synuclein for Parkinson's Diagnosis

NCT07204652 | Recruiting

• 1 other identifier: OHSU IRB # 27731
• Study Type: observational
• Target: 20
• 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. 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? Currently, Parkinson's disease is diagnosed by observing symptoms like tremors and movement problems, but by then the disease has already progressed significantly. Earlier detection could help doctors start treatment sooner.

Conditions

Parkinson; Parkinson's Disease and Parkinsonism; Parkinson Disease; PARKINSON DISEASE (Disorder)

Keywords

Parkinson; Parkinson's Disease; Parkinson disease; Parkinson Disease (Disorder)

Outcome Measures

Primary Outcomes (1)

• Detection of phosphorylated alpha-synuclein in colon tissue samples

  At time of colonoscopy procedure

Interventions

No Intervention: Observational Cohort DIAGNOSTIC_TEST

No Intervention: Observational Cohort

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 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:

• Adults 40 to 99 years of age
• Patients with a confirmed clinical diagnosis of Parkinson's disease by UKPDS Brain Bank Criteria

You may not qualify if:

• Use of anticoagulants (Plavix 75 mg or aspirin up to 325 mg alone is allowed)
• History of colon cancer
• Recent gastrointestinal illness or surgical procedures
• Pregnant or planning to become pregnant before the scheduled colonoscopy
• Significant cognitive impairment, as determined by study investigators
• Decisionally impaired adults who cannot express understanding that this study is voluntary and for research purposes

Sponsors & Collaborators

• CND Life Sciences: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Delaram Safarpour, MD, MSCE, FAAN

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magda Armendariz Sullivan

CONTACT

503-501-8478; armendam@ohsu.edu

Study Design

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

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

US (1)