Neuroinflammation in FTLD

Last updated: March 10, 2025
Sponsor: Leiden University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dementia

Speech Disorders

Progressive Supranuclear Palsy

Treatment

Clinical measures

Blood withdrawal

7T MRI scan

Clinical Study ID

NCT06870838
P21.090
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ability to undergo MRI scanning

  • For probable FTLD-tau: a clinical diagnosis of PSP, CBS or nfvPPA, or any clinicalFTLD spectrum diagnosis with a proven MAPT mutation

  • For probable FTLD-TDP: a clinical diagnosis of svPPA or any clinical FTLD spectrumdiagnosis with a proven GRN mutation or C9orf72 repeat expansion

  • For presymptomatic mutation carriers: a MAPT mutation, GRN mutation or a C9orf72mutation without clinical sign of a FTLD spectrum phenotype (CDR 0) For controlsubjects: no known neurological or psychiatric disorder

  • For controls: no known neurological or psychiatric disorder

Exclusion

Exclusion Criteria:

  • Other neurological or psychiatric disorder that may affect cognitive functions, suchas a brain tumour, multiple sclerosis or drug or alcohol abuse or use ofpsycho-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

Study Design

Total Participants: 110
Treatment Group(s): 5
Primary Treatment: Clinical measures
Phase:
Study Start date:
July 25, 2023
Estimated Completion Date:
August 31, 2026

Study 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.

Connect with a study center

  • Leiden University Medical Center

    Leiden,
    Netherlands

    Site Not Available

  • Erasmus MC

    Rotterdam, 3015GE
    Netherlands

    Active - Recruiting

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