Identify genetic causes of Parkinson
- Trial ID
- NCT05721911
- Official Title
- Implementing a National Biobank of Genetic, Sporadic and Prodromic Parkinson's Disease With Whole Genome Analysis and Functional Assessment of Polygenic Inheritance by iPSC Technology
- Goal
- Identify genetic causes of Parkinson
- Status
- RECRUITING
- Sponsor
- IRCCS San Raffaele
- Study Type
- OBSERVATIONAL
- Enrollment
- 230 participants
- Conditions
- Parkinson Disease, REM Sleep Behavior Disorder
- Interventions
- whole genome sequencing
Summary For Families
The goal is to build a national biobank linking whole genome data and lab-grown cell models to figure out how combinations of genetic variants influence Parkinson's risk, progression, and the link with REM sleep behavior disorder. Participants give samples for whole genome sequencing to find known and new risk variants and for making induced pluripotent stem cells, which are turned into neurons so researchers can test how a person’s unique polygenic profile alters cell function; the project is observational and does not change your Parkinson's medications. Adults 18 and older are eligible, including people with Parkinson's who have at least two cardinal signs with tremor or bradykinesia and a documented response to L-dopa or dopamine agonists, and people with idiopathic RBD; the study excludes those with dementia, other neurodegenerative diseases, major psychiatric conditions, or prolonged use of certain psychotropic drugs.
Locations
- IRCCS San Raffaele, Milan, Italy, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying whole genome sequencing. The goal is to build a national biobank linking whole genome data and lab-grown cell models to figure out how combinations of genetic variants influence Parkinson's risk, progression, and the link with REM sleep behavior disorder. Participants give samples for whole genome sequencing to find known and new risk variants and for making induced pluripotent stem cells, which are turned into neurons so researchers can test how a person’s unique polygenic profile alters cell function; the project is observational and does not change your Parkinson's medications. Adults 18 and older are eligible, including people with Parkinson's who have at least two cardinal signs with tremor or bradykinesia and a documented response to L-dopa or dopamine agonists, and people with idiopathic RBD; the study excludes those with dementia, other neurodegenerative diseases, major psychiatric conditions, or prolonged use of certain psychotropic drugs.
- 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 2 years and 4 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.