Lumbar punction for Parkinson's (NCT04844060)
Use spinal fluid to diagnose
- Trial ID
- NCT04844060
- Official Title
- Analysis of Clinical Data and Diagnosis in Any Person Requiring an Assay of Alzheimer Biomarkers in Cerebrospinal Fluid
- Goal
- Use spinal fluid to diagnose
- Status
- RECRUITING
- Sponsor
- University Hospital, Strasbourg, France
- Study Type
- OBSERVATIONAL
- Enrollment
- 10000 participants
- Conditions
- Alzheimer Disease, Dementia With Lewy Bodies, Frontotemporal Dementia, Parkinson's Disease Dementia, Multiple System Atrophy
- Interventions
- Lumbar punction
Summary For Families
The goal is to see how Alzheimer-related proteins in spinal fluid relate to clinical diagnoses across different brain diseases, including Parkinson's disease dementia, so clinicians can tell which condition is most likely causing symptoms. Participants have a lumbar puncture to collect cerebrospinal fluid, which is tested for biomarkers like amyloid beta, total tau, and phosphorylated tau, and those lab results are compared with clinical information to improve diagnostic accuracy. This is an observational data-gathering effort, not a treatment, so it does not change medications like levodopa. Anyone of any age or sex who is having a lumbar puncture and has reliable clinical diagnostic information can be included.
Locations
- Service d'évaluation et Centre Mémoire de Ressources et de Recherche (CM2R), Hôpital de jour Saint François - Pôle de Gériatrie, Hôpitaux Universitaires de Strasbourg, Hôpital de la Robertsau, Strasbourg, France
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Lumbar punction. The goal is to see how Alzheimer-related proteins in spinal fluid relate to clinical diagnoses across different brain diseases, including Parkinson's disease dementia, so clinicians can tell which condition is most likely causing symptoms. Participants have a lumbar puncture to collect cerebrospinal fluid, which is tested for biomarkers like amyloid beta, total tau, and phosphorylated tau, and those lab results are compared with clinical information to improve diagnostic accuracy. This is an observational data-gathering effort, not a treatment, so it does not change medications like levodopa. Anyone of any age or sex who is having a lumbar puncture and has reliable clinical diagnostic information can be included.
- Who can participate?
- Eligibility criteria vary. Check the full listing on ClinicalTrials.gov for detailed inclusion and exclusion criteria.
- 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 20 years and 10 months.
- 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.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Lumbar puncture (spinal tap) (invasive). Confirm the full schedule with the study coordinator.