Genes affect medication side effects
- Trial ID
- NCT06329739
- Official Title
- Genetics in Parkinson's Disease: Behavioral and Cognitive Outcomes in Patients Undergoing Dopaminergic Treatment
- Goal
- Genes affect medication side effects
- Status
- RECRUITING
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Study Type
- OBSERVATIONAL
- Enrollment
- 68 participants
- Conditions
- Parkinson Disease
- Interventions
- Clinical examinations and clinical scales administration
Summary For Families
The goal is to find out whether inherited genetic differences influence thinking, mood, and behavior in people with Parkinson's who are taking dopaminergic medications. Participants who have had genetic testing for Mendelian forms of Parkinson's get detailed clinical exams and standardized cognitive and behavioral scales, and researchers compare those outcomes by genetic status; levodopa and dopamine agonists boost brain dopamine to improve movement but can also cause hallucinations, sleep and memory changes, and impulse control problems, so the study looks at whether genetics affects those effects. Adults 18 and older with a Parkinson's diagnosis who are on levodopa and/or dopamine agonists and have undergone genetic testing are eligible, deep brain stimulation recipients are excluded, and participants must be able to give informed consent.
Locations
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Clinical examinations and clinical scales administration. The goal is to find out whether inherited genetic differences influence thinking, mood, and behavior in people with Parkinson's who are taking dopaminergic medications. Participants who have had genetic testing for Mendelian forms of Parkinson's get detailed clinical exams and standardized cognitive and behavioral scales, and researchers compare those outcomes by genetic status; levodopa and dopamine agonists boost brain dopamine to improve movement but can also cause hallucinations, sleep and memory changes, and impulse control problems, so the study looks at whether genetics affects those effects. Adults 18 and older with a Parkinson's diagnosis who are on levodopa and/or dopamine agonists and have undergone genetic testing are eligible, deep brain stimulation recipients are excluded, and participants must be able to give informed consent.
- 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 10 years.
- 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.