PARKINSON DISEASE (Disorder)Syn-GNCT07217054
Colonic Tissue Biopsy Detection of Phosphorylated Alpha-synuclein for Parkinson's Diagnosis or REM Sleep Behavior Disorder
An observational study of PARKINSON DISEASE (Disorder) and Parkinson, run by CND Life Sciences at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- PARKINSON DISEASE (Disorder), Parkinson, Parkinson s Disease
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2025to Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Digestive Disease Associates
Branford, Connecticut, 06405
Christina Wagner, 203-481-0315 ext. opt 2, ext 67, cwagner@ddabranford.com
Daniel J Zanchetti, MD
About this study
Official title: Detection of Phosphorylated Alpha-Synuclein in Colonic Tissue Biopsy During Routine Colonoscopy
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.
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Disease (PD) | Trial participants with Parkinson's disease | |
| REM Sleep Behavior Disorder (RBD) | Trial participants with REM Sleep Behavior Disorder (RBD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of phosphorylated alpha-synuclein in colon tissue samples
Measured: At time of colonoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2025
- Study start4 Nov 2025
- Primary completionOct 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CND Life Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217054
- Sponsor's protocol ID
- CND-107
- Acronym
- Syn-G
- Status last verified
- Feb 2026
- First submitted
- 11 Oct 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Phosphorylated Alpha-Synuclein in Colonic Tissue Biopsy During Routine Colonoscopy
- ClinicalTrials.gov ID
- NCT07217054
- Acronym / sponsor ID
- Syn-G / CND-107
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- CND Life SciencesUniversity, hospital or other
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 15 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease (PD) | – | –Trial participants with Parkinson's disease |
| REM Sleep Behavior Disorder (RBD) | – | –Trial participants with REM Sleep Behavior Disorder (RBD) |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Relatively healthy men and women ≥40-99 years of age
- Patients with a diagnosis of
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of phosphorylated alpha-synuclein in colon tissue samples
Time frame: At time of colonoscopy procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PARKINSON DISEASE (Disorder) and Parkinson, run by CND Life Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Wagner (203-481-0315 ext. opt 2, ex 67, cwagner@ddabranford.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of phosphorylated alpha-synuclein in colon tissue samples (time frame: At time of colonoscopy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.