Actively Recruiting
A US Study That Observes How Parkinson's Disease Changes Over Time in Patients Who Still Have Movement Symptoms Despite Taking Parkinson's Medications
Led by Bayer · Updated on 2026-04-20
300
Participants Needed
5
Research Sites
369 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A US Study That Observes How Parkinson's Disease Changes Over Time in Patients Who Still Have Movement Symptoms Despite Taking Parkinson's Medications
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 45 and 75 years at informed consent, with at least 30% aged 60 or older
- Clinically established Parkinson's disease diagnosis within 12 years
- Modified Hoehn and Yahr stage II-III in OFF-medication state (at least 12 hours from last medication dose)
- MDS-UPDRS part III score of 30 or higher in OFF-medication state
- Presence of motor fluctuations with at least 1 hour of OFF time per day
- Stable antiparkinsonian medication regimen for at least 4 weeks prior to screening with levodopa dose of 300 mg or more daily or dosing frequency of 3 or more times per day
- Responsiveness to levodopa shown by any improvement in modified Hoehn and Yahr stage or 30% improvement in MDS-UPDRS part III score
- Montreal Cognitive Assessment score of 24 or higher
- Agree to participate and provide signed informed consent
- Care partner aged 18 or older identified by patient and able to provide consent independently
You will not qualify if you...
- History or presence of conditions that could explain symptoms other than Parkinson's disease, including multiple system atrophy, progressive supranuclear palsy, corticobasal syndrome, vascular Parkinsonism, drug-induced Parkinsonism, essential tremor, Lewy body dementia, Huntington's disease, Wilson's disease, Alzheimer's disease, cerebrovascular disease, brain tumor, trauma, or infection
- Significant vascular or cardiovascular diseases such as stroke, transient ischemic attacks, uncontrolled hypertension or diabetes, unstable angina, or myocardial infarction
- Significant psychosis, impulse control disorder, or untreated/suboptimally treated depression
- History or presence of HIV, hepatitis B or C, syphilis, or tuberculosis
- Active or recent (within 5 years) malignant disease except certain treated skin or cervical cancers
- Currently pregnant, nursing, lactating, breastfeeding, or planning pregnancy during the study
- Use of levodopa/carbidopa intestinal gel, subcutaneous levodopa, or apomorphine pumps
- Prior brain surgery including deep brain stimulation or other experimental neurosurgical procedures
- History or current participation in cell or gene therapy procedures
- Current participation in any interventional clinical trial
AI-Screening
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Trial Site Locations
Total: 5 locations
1
The Parkinson's & Movement Disorder Institute
Fountain Valley, California, United States, 92708
Actively Recruiting
2
Keck School of Medicine
Los Angeles, California, United States, 90033
Actively Recruiting
3
Boston University
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
4
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Not Yet Recruiting
5
University of Vermont
Burlington, Vermont, United States, 05402
Not Yet Recruiting
Research Team
B
Bayer Clinical Trials Contact
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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