Spit test could spot ALS early

NCT ID NCT05928416

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether a simple saliva sample can help diagnose amyotrophic lateral sclerosis (ALS). Researchers will analyze RNA in the saliva of 653 people, including ALS patients and healthy volunteers. If the test works, it could offer a faster, less invasive way to diagnose ALS.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple, non-invasive saliva test to help diagnose ALS earlier.
What could go wrong
This is an observational study, not a treatment trial. The test may not be accurate enough to replace current diagnostic methods.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

653 people

The number who actually took part.

Started

Jul 2023

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will be made up with amyotrophic lateral sclerosis (ALS) patients defined or probable according to El Escorial criteria ("ALS patients" group) and patients with no medical history or neurological symptoms (Control Group). The control group will be made up of people accompanying the patients (with or without ALS). The ALS patients in the study already benefit from routine medical care in ALS expert centers in France. . The patients concerned by the study are managed without modification of the care pathway, no modification of the therapeutic indications, no modification of the diagnostic examinations or follow-up necessary according to the context, which are carried out according to the recommendations of the HAS.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient over 18 years of age, * Patient from one of the 2 study populations: * Diagnosis of definite or probable ALS according to El Escorial criteria ("patients ALS" group) ; * Control group * Patient able to carry out a mouth rinse, * Patient affiliated to the healthcare system, * Patient has dated and signed the consent form, Exclusion Criteria: * Recent (\<1 month) or ongoing bacterial or viral infection, * Known active oral or digestive mycosis, * Evolving, symptomatic or obvious oral pathology, * Known pregnancy, * Patient participating in another clinical research study, * Patient deprived of liberty by administrative or judicial decision or under guardianship ; * Subject refusing to take a saliva sample; * For the control group: direct relationship (siblings, descendants, ascendants) with a patient included in the study; * For control group: medical history of neurological disease (excluding migraine).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • C.H.U. de Saint-Étienne

    Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055, France

  • CHRU Lille

    Lille, 59037, France

  • CHU Angers

    Angers, 49933, France

  • CHU Bordeaux

    Bordeaux, 33000, France

  • CHU Bretonneau

    Tours, 37044, France

  • CHU Caen

    Caen, 14000, France

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003, France

  • CHU Dupuytren

    Limoges, 97042, France

  • CHU Montpellier

    Montpellier, 34295, France

  • CHU Nantes

    Saint-Herblain, Loire-Atlantique, 44162, France

  • CHU Nice

    Nice, 06100, France

  • CHU Rennes

    Rennes, 35000, France

  • CHU Strasbourg

    Strasbourg, Alsace, 67098, France

  • CHU Toulouse

    Toulouse, 31059, France

  • CHU de la Réunion

    Saint-Pierre, 97448, France

  • Hospices Civils de Lyon

    Bron, Rhône, 69677, France

  • Hôpital Cavale Blanche

    Brest, 29609, France

  • Hôpital de La Timone

    Marseille, 13005, France

  • Hôpital de la Pitié-Salpêtrière

    Paris, 75013, France

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