Rochester, MNNCT07567794Now EnrollingIRB Ready

Parkinson Disease (PD) Clinical Trial in Rochester, MN

Access cutting-edge parkinson disease (pd) treatment through this clinical trial at a research site in Rochester. Study-provided care at no cost to qualified participants.

Sponsored by Duke University

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Expert Care in Rochester

Access parkinson disease (pd) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related parkinson disease (pd) treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Rochester

    Convenient for MN residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Rochester site if eligible
  4. 4Begin participation

About This Parkinson Disease (PD) Study in Rochester

The purpose of this research study is to identify the role that the gut-brain axis, the group of nerves that connect the brain and gut, plays in Parkinson's disease (PD). The National Institute of Diabetes and Digestive and Kidney Diseases is sponsoring this research study. During this study, specific groups of participants, also known as "cohorts", will be identified based on the severity of their PD. There will also be a cohort enrolling participants who do not have Parkinson's and a cohort enrolling participants that are at risk for developing PD. Each of these cohorts will be compared to the others to assess the differences in the gut-brain connection. Participants in this study will: * meet with a medical provider * answer questionnaires * give samples of blood, stool, and saliva * have X-rays taken while swallowing different foods (swallowing study) * have X-rays taken to see how long it takes markers to move through their colon (colon transit study) * have a flexible sigmoidoscopy, where a doctor looks inside the lower part of the colon and takes small tissue samples (biopsies) from the mucosa (lining) * have samples taken of their skin * have an anorectal manometry and a balloon expulsion test, where a small tube and balloon are placed in the rectum to measure muscle function. Participation in the study will last up to 24 months (2 years).

Sponsor: Duke University

Who Can Participate

Inclusion Criteria

(All PD Cohorts)
Aged ≥21 years old and ≤80 years old
Clinical diagnosis of PD as defined by Movement Disorder Society (MDS) PD Criteria
Adequate visual, hearing, cognitive, and physical ability
Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures. Because longitudinal participation is important to the scientific goals of the program, a "best estimate" of interest, commitment, and geographic feasibility for three years will be documented by the enrolling investigator after interview with the potential enrollee Inclusion Criteria Controls
Aged ≥21 years old and ≤80 years old
No known or diagnosed neurodegenerative disease
Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures
Resides within the same household as person with PD Inclusion Criteria Prodromal Cohort
Aged ≥21 years old and ≤80 years old
Prodromal characteristics are defined by the MDS Research Criteria for PD and include either polysomnography (PSG)-confirmed rapid eye movement sleep behavior disorder (RBD) or possible RBD (questionnaire-based), with hyposmia as defined by the University of Pennsylvania Smell Identification Test (UPSIT) ≤ 15th percentile.

Exclusion Criteria

(All Cohorts)
Diagnosis of secondary or atypical parkinsonism
Laboratory Values:
Hemoglobin (Hgb) \<10
Platelets \<70,000
Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) \> 2 1/2 times upper limit of normal (ULN)
Moderate or severe renal disease with an estimated glomerular filtration rate (eGFR) \<60 mL/min/BSA \[body surface area\]) calculated using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation, or moderate or severe hepatic impairment (alkaline phosphatase \[ALP\] \>2.0 times the ULN and/or total bilirubin \>2.0 times the ULN)
Significantly above the normal range for PT/INR/PTT
Currently taking anticoagulants that are deemed exclusionary by the investigator for risk of bleeding with sigmoidoscopy procedure
Clinically significant cognitive impairment with a Montreal Cognitive Assessment (MOCA) score \<22
Clinical or laboratory findings consistent with another primary neurodegenerative disease or cognitive disorder other than PD, including but not limited to, frontotemporal lobar disease, Huntington's disease, progressive supranuclear palsy, multisystem atrophy, Creutzfeld-Jakob- Disease, Down's syndrome, cortico-basal degeneration, dementia with Lewy Bodies, Alzheimer's disease, amyotrophic lateral sclerosis, seizure disorder, stroke, or other infectious, metabolic, or systemic disease affecting the central nervous system including, but not limited to, syphilis, present hypothyroidism, present or unaddressed/treated vitamin B12 deficiency, or other screening laboratory abnormalities
Suicidality, defined as active suicidal thoughts or ideation within 6 months before Screening or at Baseline, defined as answering yes to items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS), or history of suicide attempt in previous 2 years, or, in the Investigator's opinion, at serious risk of suicide
Has cancer or has had a malignant tumor within the past 5 years. (Participants with stable untreated prostate cancer or treated/removed cutaneous carcinomas are not excluded.)
Any medical condition or systemic disease that, in the Investigator's opinion, may either put the participant at risk because of participation in the study, influence the results or proposed analyses, or impair the participant's ability to fully participate in the study
Body mass index (BMI) \>35 kg/m2 or body weight \<50 kg
Participant is currently pregnant, breastfeeding, and/or lactating
History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria)
History of Covid 19 (SARS-CoV-2) infection within 6 weeks prior to screening.
Participants with unresolved symptoms of Covid 19 infection or ongoing cognitive or other deficits attributable to post-Covid 19 that may affect participant safety or interfere with cognitive assessments based on the Investigator's clinical judgment
Either ongoing or current participation in another clinical trial with an investigational agent and have taken at least one dose of study medication, unless unblinded on placebo, within 4 weeks prior to the start of screening, or five half-lives of the investigational drug, whichever is greater. The end of a previous investigational trial is the date the last dose of an investigational agent was taken. Participation in other research studies (e.g., observational studies) may be acceptable throughout this study.
History of GI surgery. (However, patients with appendicectomy, hemorrhoid surgery, and cholecystectomy will be eligible to participate).
Regular use of medication that impacts the intestinal barrier (e.g., NSAID more than 3 times weekly)
Has a history of Crohn's disease, ulcerative colitis, and/or other types of colitis (microscopic, lymphocytic, or collagenous colitis). Confirmed diagnosis of inflammatory bowel disease (IBD) and/or, active or uncontrolled IBD symptoms such as diarrhea, bleeding, or severe stomach pain. Treatment for IBD in the past 6 months with medicines such as steroids, biologics, or strong immune-suppressing drugs. Surgery to remove part of the bowel due to IBD. Other long-term gut diseases that cause inflammation, such as celiac disease.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Rochester?

Yes, this clinical trial (NCT07567794) has an active research site in Rochester, MN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Parkinson Disease (PD) Treatment Options in Rochester, MN

If you're searching for parkinson disease (pd) treatment options in Rochester, MN, this clinical trial (NCT07567794) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Rochester research site is actively enrolling participants for this clinical trial. You'll receive care from experienced parkinson disease (pd) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all parkinson disease (pd) clinical trials near you to find additional studies recruiting in your area.

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