Clinical assessments for Parkinson's (NCT07187843)
Predict balance and thinking changes
- Trial ID
- NCT07187843
- Official Title
- Study of the Progression of Axial and Cognitive Symptoms and Biomarkers of Neurodegeneration in Patients With Parkinson's Disease Divided Into Brain-first and Body-first Phenotypes
- Goal
- Predict balance and thinking changes
- Status
- RECRUITING
- Sponsor
- Azienda USL Reggio Emilia - IRCCS
- Study Type
- OBSERVATIONAL
- Enrollment
- 150 participants
- Conditions
- Parkinson Disease, Parkinsonian Disorders, Brain Disease, Basal Ganglia Diseases, Synucleinopathies
- Interventions
- Clinical assessments, Phenotypic classification
Summary For Families
Researchers aim to tell whether early Parkinson's fits into the proposed "brain-first" or "body-first" types and how those types change posture, balance, walking, and thinking over time. Participants will have detailed exams, sleep testing, brain and heart imaging, and blood tests for markers of nerve damage and inflammation, including neurofilament light chain and immune responses to alpha-synuclein, interferon-gamma, and interleukin-5. The study is enrolling adults 18 and older who meet standard Parkinson's diagnostic criteria, can give informed consent, and can be classified as brain-first or body-first based on sleep testing for REM sleep behavior disorder plus imaging that looks at dopamine transport and heart nerve function; people under 18, those who cannot consent, or those with an uncertain diagnosis are not eligible.
Locations
- Azienda USL IRCCS di Reggio Emilia, Reggio Emilia, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Clinical assessments. Researchers aim to tell whether early Parkinson's fits into the proposed "brain-first" or "body-first" types and how those types change posture, balance, walking, and thinking over time. Participants will have detailed exams, sleep testing, brain and heart imaging, and blood tests for markers of nerve damage and inflammation, including neurofilament light chain and immune responses to alpha-synuclein, interferon-gamma, and interleukin-5. The study is enrolling adults 18 and older who meet standard Parkinson's diagnostic criteria, can give informed consent, and can be classified as brain-first or body-first based on sleep testing for REM sleep behavior disorder plus imaging that looks at dopamine transport and heart nerve function; people under 18, those who cannot consent, or those with an uncertain diagnosis are not eligible.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 2 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.