Finding early biological signs of ALS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will collect cerebrospinal fluid by lumbar puncture and clinical data from three groups: premotor gene mutation carriers, early ALS patients (including ALS mimics), and healthy control subjects. Molecular analyses will be used to develop a clinical molecular fingerprint that may reveal early pathologic changes before overt motor symptoms. The work aims to provide insight into ALS pathogenesis and to support earlier or premotor diagnosis. The study is led by INSERM with collaboration from the Technical University of Munich and will enroll participants at CHU Tours in France.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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.

Exclusion Criteria:

* 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

Where it's running

• CHU Tours
  Tours, France, France Recruiting

Study contacts

• Study coordinator: Philippe CORCIA, Professor
• Email: philippe.corcia@univ-tours.fr
• Phone: +33247473724

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.