Identify markers predicting Parkinson progression
- Trial ID
- NCT02305147
- Official Title
- Etude Des Facteurs Prédictifs De L'apparition Et De L'évolution De La Maladie De Parkinson
- Goal
- Identify markers predicting Parkinson progression
- Status
- RECRUITING
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- Study Type
- OBSERVATIONAL
- Enrollment
- 360 participants
- Conditions
- Parkinson Disease
- Interventions
- Clinical, biological and imaging followup
Summary For Families
The goal is to find clinical, biological, imaging and genetic markers that predict who will develop Parkinson's and how quickly the disease will progress. Participants have regular clinical exams, blood and genetic tests, MRI scans and dopamine transporter SPECT imaging, with SPECT measuring loss of dopamine nerve terminals and MRI checking brain structure so researchers can link symptoms to measurable changes over time. The trial is enrolling adults 18 and older in four groups: people with recent idiopathic Parkinson's diagnosed under 3 years ago, people with confirmed PD gene mutations, people at higher risk such as those with idiopathic REM sleep behavior disorder or relatives of genetically confirmed patients, and healthy volunteers. Key requirements include a normal basic cognitive screen, no contraindication to MRI or SPECT, and no drug-induced or atypical parkinsonism or recent neuroleptic use.
Locations
- Hôpital Pitié-Salpêtrière, Paris, France
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Clinical, biological and imaging followup. The goal is to find clinical, biological, imaging and genetic markers that predict who will develop Parkinson's and how quickly the disease will progress. Participants have regular clinical exams, blood and genetic tests, MRI scans and dopamine transporter SPECT imaging, with SPECT measuring loss of dopamine nerve terminals and MRI checking brain structure so researchers can link symptoms to measurable changes over time. The trial is enrolling adults 18 and older in four groups: people with recent idiopathic Parkinson's diagnosed under 3 years ago, people with confirmed PD gene mutations, people at higher risk such as those with idiopathic REM sleep behavior disorder or relatives of genetically confirmed patients, and healthy volunteers. Key requirements include a normal basic cognitive screen, no contraindication to MRI or SPECT, and no drug-induced or atypical parkinsonism or recent neuroleptic use.
- 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 15 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.