NCT07213440Recruiting
Identification of Early Markers for ALS
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
Although several molecules have been proposed as biomarker candidates, a clinically established signature for an early or even premotor diagnosis of ALS is not available. Due to the already advanced, disease stage at the time of diagnosis as well as rapid disease progression, an early diagnosis is mandatory for efficacious disease-modifying therapies. In this project, the investigators will develop a clinical molecular fingerprint of PGMC that will provide insight into the molecular pathogenesis of ALS and allow earlier diagnosis.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 8 Jan 2025
- Start date
- 30 Sept 2024
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT07213440
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 30 Sept 2024 to the primary completion date, 30 Apr 2027
- 1 site 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
- Inability to express consent to the study
- Persons subject to a judicial safeguard measure, under guardianship or curatorship.
- Linguistic incapacity or psychic refusal to read the information.
- Pregnant women
- Foreseen inability to attend scheduled visits
- Persons refusing to take one of the following samples: Acquisition of blood samples, Acquisition of tear fluid samples, Acquisition of urine sample
Who the study is looking for
- FIRST GROUP: Premotor gene mutation carriers (PGMC):
- 18-90 years of age
- Provision of a written informed consent
- Affiliation with a social security scheme or beneficiary of such a scheme
- Diagnosed by a clinically certified laboratory with a disease- causing mutation in a known ALS gene by predictive genetic testing
- No symptoms of motor neuron disease explainable otherwise than by mutation in a known ALS gene
- SECOND GROUP: Control subjects to premotor gene mutation carriers (CTR):
- 18-90 years of age
- Provision of a written informed consent
- Affiliation with a social security scheme or beneficiary of such a scheme
- No known genetic mutation and no known ALS disease in close family
- No diagnosed motor-neuron disease
- THIRD GROUP: ALS (EALS) / ALS mimics (MIM)
- 18-90 years of age
- provision of a written informed consent
- affiliation with a social security scheme or beneficiary of such a scheme
- Patients with pure motor symptom or early ALS (EALS) or ALS mimics (MIM)
- EALS are patients with pure motor symptom / early motor symptoms of ALS, including those, where the diagnosis of ALS can already be made. These may be patients who meet the following criteria:
- According to El Escorial criteria : patients who can be classified as possible ALS or those who show upper motor neuron (UMN) signs only or lower motor neuron (LMN) signs only, so that classification as possible ALS is also not possible. Symptoms should not persist for more than 12 months.
- According to Gold Coast criteria: Patients who do not fulfill the criterion of temporal progression or patients who only show UMN signs or only LMN signs in one region and thus do not fulfill the diagnostic criteria of ALS.
Age in the registry: 18 years to 90 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Tours Coordinator of this site? Confirm its status | Tours | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.