Recruiting

Observational Study

Sponsor:

CND Life Sciences

Code:

NCT07217054

Conditions

PARKINSON DISEASE (Disorder)

Parkinson

Parkinson s Disease

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07217054

Start date

Nov 4, 2025

Status verified date

Feb, 2026

Completion date

Oct, 2029

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not 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

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Parkinson's Disease (PD)

Trial participants with Parkinson's disease

REM Sleep Behavior Disorder (RBD)

Trial participants with REM Sleep Behavior Disorder (RBD)

Primary outcome measure

  • Detection of phosphorylated alpha-synuclein in colon tissue samples [ Time Frame: At time of colonoscopy procedure ]

Central Contacts and Locations

Central contacts

Locations

Digestive Disease Associates

Recruiting

Branford, Connecticut, United States, 06405

Contacts

Principal Investigator:

Daniel J Zanchetti, MD

More Information

Sponsor

CND Life Sciences

Last update posted

Feb 11, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by CND Life Sciences on 2026-02-11.