An investigator-initiated prospective, longitudinal, single center, observational study to investigate biomarkers of TDP-43 and oxidized lipid metabolism in Amyotrophic Lateral Sclerosis (ALS).

An investigator-initiated prospective, longitudinal, single center, observational study to investigate biomarkers of TDP-43 and oxidized lipid metabolism in Amyotrophic Lateral Sclerosis (ALS). - ALS-Biomarker Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56755

Enrollment

100

Registered

2024-02-07

Start date

2024-06-13

Completion date

Unknown

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ALS Lou Gehrig Disease ALS

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Signed informed consent - Age above 18 years - Diagnosis ALS

Exclusion criteria

Exclusion criteria: - Fulfilling the criteria for respiratory insufficiency (non-invasive ventilation use >23 hours per day for 10 consecutive days or having a tracheostomy) - MiToS stage 2, 3 or 4 - confirmed FUS or SOD1 mutation - Contraindication to lumbar puncture - Any of the following medically significant conditions: 1. Neurological impairment/dysfunction or unstable psychiatric illness that in the investigator*s opinion is likely to interfere with assessment of ALS disease progression. 2. Clinically significant unstable medical condition other than ALS, which would present a risk to a patient to participate in the study 3. Presence of dementia that impairs the ability of the subject to provide informed consent, according to the PI decision. 4. Cancer that is currently under active treatment or is likely to require treatment during the study that may alter the subject*s function and thereby interfere with assessment of ALS disease progression. 5. Any other condition that in the investigator*s opinion would present a risk to a patient to participate in the study, interfere with the assessment of safety or has an increased risk of causing death during the study.

Design outcomes

Primary

Measure	Time frame
Biomarker levels of oxidized lipid metabolism and TDP-43 pathology in blood at time 0, 4,8 and 12 months and CSF at time 0 and 12 months, and changes of biomarker levels of oxidized lipid metabolism and TDP-43 over time.	—

Secondary

Measure	Time frame
Association of biomarker levels with phenotypical characteristics over time, e.g. time from onset of symptoms, ALSFRS-R, MiToS stage, site of onset (Limb/Bulbar), respiratory function, time to ventilation/death.	—

Countries

Netherlands

Contacts

Public ContactL.A. Berg

Universitair Medisch Centrum Utrecht

l.a.v.denberg-16@umcutrecht.nl0887559576

Outcome results