Clinical, biological and imaging f… for Parkinson's (NCT02305147)
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
- ACTIVE_NOT_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?
- 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 15 years.
- 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.
- How many visits does this trial involve?
- Subjects are assessed at baseline and then every year during a four-year study.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Biopsy (invasive); Skin biopsy (minimally invasive). Confirm the full schedule with the study coordinator.