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?
- 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 20 years and 10 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.