ClinicalTrials.gg
RecruitingNCT07217054Syn-GUpdated Feb 11, 2026

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

An observational study in PARKINSON DISEASE (Disorder), Parkinson and Parkinson s Disease, sponsored by CND Life Sciences. Recruiting at 1 site in United States. Open to participants aged 40 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-02-11.

Sponsored by CND Life Sciences · Observational

From the registry’s dates

  • Started Nov 2025; still recruiting 1 year later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
40
Ages
40 Years to 99 Years
Sex
All
01

Study 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.

Read the detailed description

What is this study about? This study is testing whether doctors can detect signs of Parkinson's disease or REM Sleep Behavior Disorder (RBD) by taking small tissue samples from the colon during a routine colonoscopy. Researchers want to see if they can find a specific protein called alpha-synuclein that builds up in people with Parkinson's disease or RBD.

Why is this study important? Currently, Parkinson's disease is diagnosed mainly by observing symptoms like tremors and movement problems and RBD is characterized by the loss of muscle atonia during REM sleep. However, by the time these symptoms appear, the disease has already progressed significantly. Finding a way to detect the disease earlier could help doctors start treatment sooner and potentially slow down the disease.

Who can participate?

Adults between 40-99 years old People who have already been diagnosed with Parkinson's disease or REM Sleep Behavior Disorder People who are already scheduled to have a routine colonoscopy for colon cancer screening or other medical reasons What happens during the study?

**During the colonoscopy:**

The colonoscopy procedure remains exactly the same as planned. Doctors will take 4 additional small tissue samples (2 from each side of the colon).

This adds only about 2 minutes to the procedure.

**After the colonoscopy:**

No additional visits are required. The tissue samples will be tested for the alpha-synuclein protein. Participants will not receive individual test results.

What are the risks?

The main risks are the same as any routine colonoscopy, including:

Discomfort during the procedure. Very rare complications like bleeding or bowel perforation. Small risk of infection. Possible breach of medical privacy (researchers take steps to protect this).

What are the benefits?

Participants help advance research that could lead to earlier detection of Parkinson's disease or REM Sleep Behavior Disorder.

This could eventually help future patients get diagnosed and treated sooner. There are no direct medical benefits to participants.

How many people will be in this study? 20 people with Parkinson's disease and 20 people with REM Sleep Behavior Disorder will participate in this study at Digestive Disease Associates (DDA).

How long does participation take?

The colonoscopy procedure (same length as normally planned).

This research is sponsored by CND Life Sciences and conducted at DDA.

02

Conditions studied

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

Browse trials for

03

In context

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

This study's planned enrollment of 40 is below the median of 96 across 1,085 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

CND Life Sciences is the lead sponsor of 8 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • Parkinson's Disease (PD)

    Trial participants with Parkinson's disease

  • REM Sleep Behavior Disorder (RBD)

    Trial participants with REM Sleep Behavior Disorder (RBD)

06

What researchers measure

Primary outcomes

  1. Detection of phosphorylated alpha-synuclein in colon tissue samples

    Time frame: At time of colonoscopy procedure

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2025 (actual). Primary completion is estimated for Oct 2028, 35 months after the start.

Of 378 non-industry observational studies under Parkinson Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 133. This study's planned 35 months is below that.

Counting every sponsor, half of 438 studies reached it within 47 months; a quarter within 22 and three quarters within 114.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2025
First posted
Oct 15, 2025
StartActual
Nov 4, 2025
Primary completionEst.
Oct 2028
CompletionEst.
Oct 2029
Last update
Feb 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07217054
Lead sponsor
CND Life Sciences
Responsible party
Sponsor
First posted
Oct 15, 2025
Start date
Nov 4, 2025
Primary completion
Oct 2028 (estimated)
Completion
Oct 2029 (estimated)
Last update
Feb 11, 2026

Study contacts

Christina Wagner
Contact
cwagner@ddabranford.com
203-481-0315 ext. opt 2, ex 67

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion