NCT06870838

Neuroinflammation in FTLD

Neuroinflammation in Frontotemporal Lobar Degeneration - a Multimodal Biomarker Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 110 (estimated)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

At baseline, the study will involve the following procedures: clinical assessment including neurological and neuropsychological investigation, blood sampling, and a voluntarily lumbar puncture on the first day at the Erasmus MC University Medical Center, (EMC) and two sessions of 7T MRI scanning on the second day at the Leiden University Medical Center (LUMC). After one year, clinical assessment and blood analyses will be repeated in the EMC to assess disease progression. The aim is to include 25 patients with probable or definite FTLD-tau, 25 patients with probable or definite FTLD-TDP, 50 healthy individuals with 50% risk to carry a mutation in MAPT or GRN, or the C9orf72 HRE. If necessary for age matching, 10 additional healthy subjects without increased risk of FTLD will be included.

Conditions

• Corticobasal Syndrome(CBS)
• Primary Progressive Aphasia(PPA)
• Progressive Supranuclear Palsy(PSP)
• Behavioral Variant Frontotemporal Dementia (bvFTD)
• Frontotemporal Lobar Degeneration (FTLD)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	7T MRI scan	MRI-scanning of the brain using a 7T MRI scanner
DIAGNOSTIC_TEST	CSF	CSF collection via lumbar puncture
DIAGNOSTIC_TEST	Blood withdrawal	Blood is collected by doing a blood withdrawal
DIAGNOSTIC_TEST	Neuropsychological assessment	Tests for memory, language, attention, executive functions, praxis, social cognition, visuoconstructive skills
DIAGNOSTIC_TEST	Clinical measures	Medical history, neurological assessment, neuropsychiatric inventory

Timeline

• Start date: 2023-07-25
• Primary completion: 2025-08-01
• Completion: 2026-08-01
• First posted: 2025-03-11
• Last updated: 2025-09-11

Locations

2 sites across 1 country: Netherlands