NCT06870838Active, not recruiting
Neuroinflammation in FTLD
Neuroinflammation in Frontotemporal Lobar Degeneration - a Multimodal Biomarker Study
Source: ClinicalTrials.gov · Last updated 11 Sept 2025
Brief summary (registry, in English)
The goal of this observational study is to investigate the role of neuroinflammation in frontotemporal lobar degeneration (FTLD). The main aims of this study are: 1. To elucidate the role and timing of neuroinflammation in FTLD by using a combination of clinical measures, 7T MRI, and CSF biomarkers; 2. To differentiate FTLD-TDP and FTLD-tau during life using biomarkers for neuroinflammation; 3. To identify biomarkers to predict and monitor disease progression in FTLD; Secondary aim: 1\. To explore the role of brain clearance in the disease process of FTLD. Participants will undergo 7T MRI scans, blood and CSF collection, clinical, neurological, and neuropsychological evaluation.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 110 (estimated)
- First submitted
- 3 Feb 2025
- Start date
- 25 Jul 2023
- Primary completion date
- 1 Aug 2025
- Lead sponsor
- Leiden University Medical Center
- Diseases
- Frontotemporal dementia
- NCT number
- NCT06870838
What you commit to
- Study type: Observational
- Planned participants: 110
- From 25 Jul 2023 to the primary completion date, 1 Aug 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Clinical dementia Rating Scale (CDR) score \>1
Other
- CSF profile (β-amyloid, p-tau, t-tau) suggestive of AD pathology
- Contra-indication to undergo MRI
- Contra-indication to undergo lumbar puncture
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Leiden University Medical Center Coordinator of this site? Confirm its status | Leiden | Netherlands | Unknown status |
| Erasmus MC Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.