A US Study That Observes How Parkinson's Disease Changes Over Time in Patients Who Still Have Movement Symptoms Despite Taking Parkinson's Medications (NCT07330258)
A Natural History Study of Treated Parkinson's Disease Patients Experiencing Motor Complications
๐ฉบ Plain-English Summary (8th-Grade Level)
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, ฮฑ-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.
Who can join: Review the eligibility criteria below.
Location: Banner Alzheimer's Institute (BAI)-Phoenix โ Phoenix, Arizona
Age range: 45 Years to 75 Years
๐งช Interventions in This Study
- Standard of Care (OTHER)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (26 Sites)
Showing the first 25 of 26 sites.
- Banner Alzheimer's Institute (BAI)-Phoenix โ Phoenix, Arizona
- University of Arizona Banner Alzheimer's Institute (BAI)-Tucson โ Tucson, Arizona
- The Parkinson's & Movement Disorder Institute โ Fountain Valley, California
- Keck School of Medicine โ Los Angeles, California
- Baptist Health Miami Neuroscience Institute โ Miami, Florida
- AdventHealth Neuroscience Institute โ Orlando, Florida
- University of South Florida โ Tampa, Florida
- Morehouse Healthcare โ Atlanta, Georgia
- Medical College of Georgia at Augusta University โ Augusta, Georgia
- Northwestern Memorial HealthCare at Central DuPage Hospital โ Winfield, Illinois
- MedStar Montgomery Medical Center โ Olney, Maryland
- Boston Medical Center โ Boston, Massachusetts
- University of Michigan โ Ann Arbor, Michigan
- Rutgers - Robert Wood Johnson Medical School โ New Brunswick, New Jersey
- Northwell Health โ New York, New York
- Stony Brook University โ Stony Brook, New York
- University of Buffalo โ Williamsville, New York
- Cleveland Clinic โ Cleveland, Ohio
- Thomas Jefferson University โ Philadelphia, Pennsylvania
- Baylor College of Medicine โ Houston, Texas
- University of Texas Health Science Center at Houston โ Houston, Texas
- Intermountain Health โ Murray, Utah
- University of Vermont โ Burlington, Vermont
- University of Virginia โ Charlottesville, Virginia
- Sentara Neurology Specialists โ Norfolk, Virginia
๐ Contact the Study Coordinator
Phone: (888) 842-2937
Email: clinical-trials-contact@bayer.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Parkinson's Disease
- Genotypic Influences on Network Progression in Parkinson's Disease โ Manhasset, New York
- Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations โ Phoenix, Arizona
- Long-term Follow-up of Glutamic Acid Decarboxylase (GAD) Gene Transfer in Parkinson's Disease โ New Haven, Connecticut
- Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in GBA-PD โ Phoenix, Arizona
- Cont. of a Study to Evaluate Implanting Peripheral Nerve Grafts Into Subjects With Parkinson's Disease (PD) During DBS โ Lexington, Kentucky
- ExAblate Transcranial MRgFUS for Unilateral Pallidotomy for the Treatment of Parkinson's Disease โ Toronto, Ontario
Explore by condition: All Parkinson's Disease clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.