Investigating neuroinflammation in frontotemporal lobar degeneration
Neuroinflammation in Frontotemporal Lobar Degeneration - a Multimodal Biomarker Study
This study is trying to see how inflammation in the brain affects people with frontotemporal lobar degeneration and includes both patients with the condition and healthy individuals at risk for it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 2 sites (Leiden and 1 other locations) |
| Trial ID | NCT06870838 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the role of neuroinflammation in frontotemporal lobar degeneration (FTLD) using advanced techniques such as 7T MRI and biomarker analysis. Participants will undergo clinical assessments, blood sampling, and lumbar punctures to collect cerebrospinal fluid (CSF). The study will include patients diagnosed with various forms of FTLD and healthy individuals at risk for genetic mutations associated with the disease. Follow-up assessments will be conducted after one year to monitor disease progression and evaluate the effectiveness of identified biomarkers.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with FTLD-tau or FTLD-TDP, as well as presymptomatic mutation carriers.
Not a fit: Patients with other neurological or psychiatric disorders that may affect cognitive functions will likely not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and monitoring of FTLD, potentially guiding future therapeutic interventions.
How similar studies have performed: While the approach of using neuroinflammation biomarkers in FTLD is promising, it is still relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to undergo MRI scanning * For probable FTLD-tau: a clinical diagnosis of PSP, CBS or nfvPPA, or any clinical FTLD spectrum diagnosis with a proven MAPT mutation * For probable FTLD-TDP: a clinical diagnosis of svPPA or any clinical FTLD spectrum diagnosis with a proven GRN mutation or C9orf72 repeat expansion * For presymptomatic mutation carriers: a MAPT mutation, GRN mutation or a C9orf72 mutation without clinical sign of a FTLD spectrum phenotype (CDR 0) For control subjects: no known neurological or psychiatric disorder * For controls: no known neurological or psychiatric disorder Exclusion Criteria: * Other neurological or psychiatric disorder that may affect cognitive functions, such as a brain tumour, multiple sclerosis or drug or alcohol abuse or use of psycho-active medications * CSF profile (β-amyloid, p-tau, t-tau) suggestive of AD pathology * Clinical dementia Rating Scale (CDR) score \>1 * Contra-indication to undergo MRI * Contra-indication to undergo lumbar puncture
Where this trial is running
Leiden and 1 other locations
- Leiden University Medical Center — Leiden, Netherlands (Active_not_recruiting)
- Erasmus MC — Rotterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Elise Dopper, MD PhD
- Email: e.dopper@erasmusmc.nl
- Phone: +31107030916
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.