Track axial and cognitive progression
- 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
- Track axial and cognitive progression
- 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
The goal is to compare how balance, gait, posture and thinking skills change over time in people with Parkinson's who show a brain-first pattern versus a body-first pattern. Participants are sorted into those groups using overnight polysomnography to look for REM sleep behavior disorder, SPECT DAT scans to measure dopamine transporter loss, and 123I‑MIBG heart scans to assess cardiac autonomic involvement, then receive regular clinical assessments and biomarker testing to track axial and cognitive progression. DAT SPECT shows nigrostriatal dopamine loss and MIBG reveals peripheral autonomic denervation, helping explain different symptom patterns. Adults 18 and older with a confirmed Parkinson's diagnosis who can give informed consent are eligible, while people with a doubtful diagnosis or who cannot consent are excluded.
Locations
- Azienda USL IRCCS di Reggio Emilia, Reggio Emilia, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Clinical assessments. The goal is to compare how balance, gait, posture and thinking skills change over time in people with Parkinson's who show a brain-first pattern versus a body-first pattern. Participants are sorted into those groups using overnight polysomnography to look for REM sleep behavior disorder, SPECT DAT scans to measure dopamine transporter loss, and 123I‑MIBG heart scans to assess cardiac autonomic involvement, then receive regular clinical assessments and biomarker testing to track axial and cognitive progression. DAT SPECT shows nigrostriatal dopamine loss and MIBG reveals peripheral autonomic denervation, helping explain different symptom patterns. Adults 18 and older with a confirmed Parkinson's diagnosis who can give informed consent are eligible, while people with a doubtful diagnosis or who cannot consent are excluded.
- 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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 2 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.