A US Study That Observes How Parkinson's Disease Changes Over Time in Patients Who Still Have Movement Symptoms Despite Taking Parkinson's Medications
Recruiting
Observational Study
Parkinson's Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
45 – 75
Sex
Any
Study type
Observational
Participants needed
300 (estimated)
Sponsor
Bayer · Industry
Who this trial is looking for
This trial is looking for people with Parkinson's disease who still have movement symptoms even though they are on medication. Participants will help researchers understand how the condition changes over time without altering their current treatment.
Are You a Good Fit for This Trial?
Must be takingLevodopa
Rules you outMultiple system atrophyProgressive supranuclear palsyHuntington's diseaseAlzheimer's disease
You may be able to join if
I am between 45 and 75 years old.
I have been diagnosed with Parkinson's disease.
I have moderate to advanced Parkinson's symptoms.
I experience motor fluctuations with at least 1 hour of OFF state daily.
I have been on stable Parkinson's medication for at least 4 weeks.
I show responsiveness to my Parkinson's medication.
I scored at least 24 on the Montreal Cognitive Assessment.
I agree to participate and will provide signed consent.
You may not be able to join if
I have a history of conditions that could explain my symptoms other than Parkinson's.
I have significant heart or vascular disease.
I have a significant mental health condition not under control.
I have a history of certain infections like HIV or hepatitis.
I have had active cancer in the last 5 years.
I am currently pregnant or nursing.
I have used specific devices for Parkinson's treatment.
I have had certain types of brain surgery.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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.
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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…
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.
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