Evaluating BDNF Biomarkers in Cerebrospinal Fluid for Huntington's Disease
Study of Brain Derived Neurotrophic Factor (BDNF) Pathway Biomarkers in the Cerebrospinal Fluid in Patients With Huntington's Disease
NA · University Hospital, Montpellier · NCT04012411
This study is testing if measuring a protein in the spinal fluid can help understand Huntington's Disease better and see how it relates to the disease's severity and brain changes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 135 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier (other) |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT04012411 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the levels of Brain Derived Neurotrophic Factor (BDNF) in the cerebrospinal fluid of patients with Huntington's Disease (HD) to explore its potential as a biomarker for the BDNF-TrkB signaling pathway. It is a multicenter, prospective case-control study involving several university hospitals in France. The study will also evaluate plasma BDNF levels, correlate these with clinical severity and brain MRI parameters, and confirm the presence of other neuronal degeneration markers. Participants will include genetically confirmed HD patients and control subjects who have undergone lumbar puncture for medical reasons.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with genetically confirmed Huntington's Disease.
Not a fit: Patients with advanced stages of Huntington's Disease that interfere with cognitive evaluations or MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new biomarker for monitoring disease progression and treatment response in Huntington's Disease.
How similar studies have performed: While studies have explored biomarkers in Huntington's Disease, the specific focus on BDNF in cerebrospinal fluid is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * General inclusion criteria: * age ≥ 18 years-old * national health insurance cover * Patients inclusion criteria: * genetically confirmed Huntington's disease diagnosis (≥ 35 CAG repeat in HTT gene exon 1) * written informed consent * only for patients "with lumbar puncture (LP)": patient agreement for LP * Control inclusion criteria: * anterior LP for medical reason with consent for biobank "Neuro" with following samples present in this biobank : 2 mL blood + 0.5 mL plasma + 0.5 mL cerebrospinal fluid * information and non-opposition for the finality of this biobank * paired by age with a patient (+/- 5 years difference) Exclusion Criteria: * General exclusion criteria: * protected by law * Patients exclusion criteria: * Huntington's disease stage too Evolved that may interfere with cognitive evaluations or MRI * contraindications to brain MRI * only for patients "with LP": contraindications to LP * incapacity to give informed consent * Control exclusion criteria: * neurodegenerative of inflammatory central nervous system pathology
Where this trial is running
Montpellier
- University Hospital of Montpellier — Montpellier, France (RECRUITING)
Study contacts
- Study coordinator: Cecilia MARELLI, MD
- Email: c-marelli@chu-montpellier.fr
- Phone: +33(0)467336029
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Huntington Disease, CSF, Biomarkers, BDNF, P42