RightFit
RecruitingPhase not listed

A US Study That Observes How Parkinson's Disease Changes Over Time in Patients Who Still Have Movement Symptoms Despite Taking Parkinson's Medications

A Natural History Study of Treated Parkinson's Disease Patients Experiencing Motor Complications

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years
  • Procedures mentioned: Blood draws, Biopsies, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Data will come from questionnaires or rating scales conducted by the doctor with the patient during study visits, diaries and logs completed by the patient, medical records, health insurance claims records, blood samples and skin biopsies, a digital device that records movement/non-movement symptoms, and questionnaires completed by the care partner."
  • "Each participant may be followed for up to 5 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This US study follows people ages 45–75 who still have movement problems while taking Parkinson's medicines. It looks at how the disease changes, how treatments work, and the challenges patients and care partners face. People may be followed for up to 5 years, with no study drug or changes to their usual care.

This is an observational study in which data are collected and studied from Parkinson's disease patients who have movement symptoms despite taking standard Parkinson's medications. In observational studies, observations are made without any changes to the participant's healthcare or treatment plan. No investigational product will be administered in this study, as participants will be treated with the standard of care that medical experts currently consider most appropriate. Parkinson's disease (PD) is a condition that affects the brain and causes problems with movement and other body functions. The symptoms of Parkinson's disease can worsen over time. People with Parkinson's disease may experience shaking (tremor), slow movements, stiff muscles, trouble walking, and problems with balance. They can also have other symptoms, such as difficulty thinking clearly, changes in mood, or difficulty sleeping. Parkinson's disease mostly affects older adults, but it can happen to younger people too. There is no cure, but treatments can help manage the symptoms and improve quality of life. While doctors and researchers know that Parkinson's disease affects people in different ways and can worsen over time, there are still many things they don't fully understand-especially for people who experience movement symptoms despite taking their usual Parkinson's medicines. Earlier studies did not follow these patients long enough or collect all the important information needed. This study is being done to fill those gaps. The main purpose of this study is to better understand how Parkinson's disease changes over time in patients who experience movement symptoms while taking standard oral Parkinson's medications, what challenges patients and their care partners face, and how their treatments are working in real life. To do this, researchers will collect data on: * Sociodemographics (e.g. age, gender, race/ethnicity, insurance provider). * Medical history and vital signs (e.g. comorbidities, family history of Parkinson's, height, weight, blood pressure). * Medications and treatments (e.g. Parkinson's and non-Parkinson's medications and other treatments, rehabilitation therapy sessions, use of mobility assistance devices). * Movement symptoms (e.g. tremor, slow movement, balance). * Non-movement symptoms (e.g. cognition, mood, sleep, activities of daily living). * Molecular data (e.g. genetics, α-synuclein). * Burden of care (e.g. economic cost). Data will come from questionnaires or rating scales conducted by the doctor with the patient during study visits, diaries and logs completed by the patient, medical records, health insurance claims records, blood samples and skin biopsies, a digital device that records movement/non-movement symptoms, and questionnaires completed by the care partner. Data will be collected from December 2025 to December 2032. Each participant may be followed for up to 5 years.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Patients must be ages 45–75 and have had a confirmed Parkinson's diagnosis for at least 4 years but less than 12 years.
  • After at least 12 hours without Parkinson's medicine, patients must have a disease stage of II–III and a movement test score of at least 30.
  • Patients must have changing movement symptoms, with at least 1 hour each day when medicine does not control symptoms well. This is called OFF time.
  • Parkinson's medicines must be unchanged for at least 4 weeks before screening. Patients must take levodopa at least 300 mg daily or at least 3 times a day.
  • Levodopa must improve the disease stage score by at least 0.5 point or the movement test score by at least 30%.
  • Patients must score at least 24 on the MoCA, a test of memory and thinking.
  • Patients must agree to join and sign a consent form.
  • Care partners must be at least 18, be named by the patient as their main care partner, and agree and sign consent on their own.

Who can't join

  • Patients cannot have another condition that could explain their symptoms instead of Parkinson's, such as another brain disease, brain injury, tumor, or infection.
  • Patients cannot have a history of stroke or mini-stroke, poorly controlled blood pressure or diabetes, or unstable chest pain or heart attack.
  • Patients cannot have serious psychosis, such as seeing things that are not there; serious trouble controlling urges; or depression that is untreated or not treated well enough.
  • Patients cannot have a history of HIV, hepatitis B or C, syphilis, or tuberculosis.
  • Patients cannot have current cancer or cancer active within the past 5 years. Exceptions include fully treated squamous or basal cell skin cancer and early cervical cancer that has not spread.
  • Patients cannot be pregnant or breastfeeding, or plan to be during the study.
  • Patients cannot have used levodopa/carbidopa gel delivered into the intestine, levodopa delivered under the skin, or an apomorphine pump.
  • Patients cannot have had brain surgery or cell or gene therapy, or currently be in a trial that tests a treatment or procedure.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria for Patient: * Individual of any sex ≥45 to ≤75 years of age at informed consent (at least 30% ≤60 years of age). * Diagnosis of clinically established Parkinson's disease (PD) as defined by the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for PD ≥4 and \<12 years from time of PD diagnosis at informed consent. * Modified H\&Y stage II-III in the practically defined OFF-medication state (≥12 hours from last dose of antiparkinsonian medications). * Score of ≥30 on MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III in the OFF-medication state. * Presence of motor fluctuations with ≥1 hour of absolute time in the OFF state per day as assessed by clinician/patient at screening. * Receiving stable antiparkinsonian medication regimen for ≥4 weeks prior to screening with a levodopa daily dose ≥300 mg or a dosing frequency of ≥3 times per day. * Responsiveness to levodopa as determined by change in the following measures from the practically defined OFF state to ON state after taking typical first-daily dose of PD-medications: i. any degree of improvement (≥0.5 point) in modified H\&Y stage OR. ii. ≥30% improvement in MDS-UPDRS part III score. * Montreal Cognitive Assessment (MoCA) score of ≥24. * Agree to participate and provide signed informed consent. Exclusion Criteria for Patient: * Known history or presence of conditions that may provide an alternative to a PD diagnosis including but not limited to: multiple system atrophy, progressive supranuclear palsy, striatonigral degeneration, corticobasal syndrome/degeneration, vascular Parkinsonism, drug-induced Parkinsonism, essential tremor, diffuse Lewy body disease, Lewy body dementia, Huntington's disease, Wilson's disease, Fahr's disease, Alzheimer's disease, cerebrovascular disease, brain tumor, trauma, and infection. * Known history or presence of significant vascular and/or cardiovascular disease limited to: stroke, transient ischemic attacks, poorly controlled hypertension, poorly controlled diabetes, unstable angina pectoris, or unstable myocardial infarction. * Known history or presence of significant psychosis or impulse control disorder, or untreated or sub optimally treated depression. * Known history or presence of human immunodeficiency virus, hepatitis B virus, hepatitis C virus, syphilis, or tuberculosis. * Current or previously active malignant disease within the past 5 years, except definitively treated cutaneous squamous cell carcinoma, basal cell carcinoma, or in situ uterine cervical carcinoma. * Currently pregnant, nursing, lactating, breastfeeding, or plan to be during study duration. * Known history or current use of percutaneous levodopa/carbidopa intestinal gel, subcutaneous levodopa, or apomorphine pump. * Prior history of brain surgery, including but not limited to: deep brain stimulation (DBS), pallidotomy, focused ultrasound thalamotomy, or other experimental neurosurgical procedure. * Known history or current participation in cell or gene therapy procedures. * Current participation in any interventional clinical trial. Inclusion Criteria for Care Partner: * ≥18 years of age at informed consent. * Identified by the PD patient as their primary care partner. * Agree to participate and the ability to provide signed informed consent independently, without the need for a legal representative. Exclusion Criteria for Care Partner: * Not applicable.

Study sites (27)

AZ

CA

CT

  • Yale School of Medicine's Stephen and Denise Adams Center for Parkinson's Disease Research · New Haven, CT 06510More trials in New Haven

FL

GA

IL

MA

MD

MI

NJ

NY

OH

PA

TX

UT

VA

VT

WA