Social CognitionCOSISLANCT04406675
Social Cognition in Patients With Amyotrophic Lateral Sclerosis
A study testing neuropsychological test in people with Social Cognition, run by University Hospital, Angers at 1 site in France.
Trial summary
Amyotrophic Lateral Sclerosis, also known as Charcot disease, is a neurodegenerative disease evidenced by gradual paralysis of the muscles involved in voluntary motor function. The clinical hallmark of Amyotrophic Lateral Sclerosis is the combination of upper and lower motor neuron signs and symptoms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Cognition
- What is being tested?
- neuropsychological test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 21 Sep 2020to 29 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient Amyotrophic Lateral Sclerosis :
- Education of at least 7 years
- Native language: French
- Patients Amyotrophic Lateral Sclerosis
- Signature of informed consent to participate in the study
- Accompanied patient
Show all 11Show fewer
- Control subject :
- People without any pathology
- Education of at least 7 years
- Native language: French
- Signature of informed consent to participate in the study
Who cannot join
- Patient Amyotrophic Lateral Sclerosis and control subject :
- Simultaneous participation in another interventional protocol with experimental treatment
- Inability to perform cognitive study tests
- Pregnant, lactating or parturient women
- Persons deprived of their liberty by administrative or judicial decision
- Persons under psychiatric care under duress
Show all 10Show fewer
- Persons subject to legal protection measures
- Persons out of state to express their consent
- People not affiliated or not beneficiaries of a social security scheme
- History likely to disturb cognition
Trial locations and contacts
1 site in 1 country.
About this study
Amyotrophic Lateral Sclerosis, also known as Charcot disease, is a neurodegenerative disease evidenced by gradual paralysis of the muscles involved in voluntary motor function. The clinical hallmark of Amyotrophic Lateral Sclerosis is the combination of upper and lower motor neuron signs and symptoms. The most recent studies suggest that up to 50% of Amyotrophic Lateral Sclerosis patients demonstrate mild to moderate cognitive disturbance. Impaired social cognition, including a deficit in the recognition of facial emotions and the identification of vocal prosody, is recognized as a part of the cognitive phenotype of Amyotrophic Lateral Sclerosis, with crucial implications for patients' and caregivers' training. However, studies remain scarce and the data acquired must be supported. The evolution of these manifestations during the disease is still poorly understood.
In this study the investigators aim to assess the social cognition capacities of patients with Amyotrophic Lateral Sclerosis compared to healthy matched control subjects.
- Conditions
- Social Cognition
- Being tested
- neuropsychological test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuropsychological testOther
neuropsychological test
| Study group | Role | What they receive |
|---|---|---|
| Patients Amyotrophic Lateral Sclerosis | Other | Not described Receives: Other: neuropsychological test |
| Control subjects | Other | Not described Receives: Other: neuropsychological test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the social cognition capacities
Evaluate the social cognition capacities of patients with Amyotrophic Lateral Sclerosis compared to control subjects using dynamic social cognition tests : Movie for the Assessment of Social Cognition. The maximum score is 48 points. The higher the score for correct answers, the better the performance.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start21 Sep 2020
- Primary completion29 May 2026
- Study completion29 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social CognitionStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406675
- Sponsor's protocol ID
- 2020-A01213-36
- Acronym
- COSISLA
- Status last verified
- Jun 2026
- First submitted
- 13 May 2020
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared later upon request (e.g., the CRF to allow a collaborator to select the data to which they wish to have access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the MIVAR investigator, based on a protocol provided by the applicant, after verification of obtaining regulatory authorizations, including the favorable opinion of an ethics committee.
Publications
Faure-de Baets J, Besnard J, Cassereau J, Emmelin E, Allain P. Assessment of social cognition in patients with amyotrophic lateral sclerosis: protocol for a cross-sectional comparative study at Angers University Hospita. BMJ Open. 2025 Jul 5;15(7):e097543. doi: 10.1136/bmjopen-2024-097543.
PubMed 40617623
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Cognition in Patients With Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT04406675
- Acronym / sponsor ID
- COSISLA / 2020-A01213-36
- Conditions
- Social Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 29 May 2026 (actual)
- Study completion
- 29 May 2026 (actual)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Amyotrophic Lateral Sclerosis, also known as Charcot disease, is a neurodegenerative disease evidenced by gradual paralysis of the muscles involved in voluntary motor function. The clinical hallmark of Amyotrophic Lateral Sclerosis is the combination of upper and lower motor neuron signs and symptoms. The most recent studies suggest that up to 50% of Amyotrophic Lateral Sclerosis patients demonstrate mild to moderate cognitive disturbance. Impaired social cognition, including a deficit in the recognition of facial emotions and the identification of vocal prosody, is recognized as a part of the cognitive phenotype of Amyotrophic Lateral Sclerosis, with crucial implications for patients' and caregivers' training. However, studies remain scarce and the data acquired must be supported. The evolution of these manifestations during the disease is still poorly understood.
In this study the investigators aim to assess the social cognition capacities of patients with Amyotrophic Lateral Sclerosis compared to healthy matched control subjects.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients Amyotrophic Lateral Sclerosis | Other | Other: neuropsychological test |
| Control subjects | Other | Other: neuropsychological test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Education of at least 7 years
- Native language: French
- Patients Amyotrophic Lateral Sclerosis
- Signature of informed consent to participate in the study
- Accompanied patient
Key exclusion criteria (10 listed)
- Simultaneous participation in another interventional protocol with experimental treatment
- Inability to perform cognitive study tests
- Pregnant, lactating or parturient women
- Persons deprived of their liberty by administrative or judicial decision
- Persons under psychiatric care under duress
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuropsychological testneuropsychological test | Other | Control subjects, Patients Amyotrophic Lateral Sclerosis |
Primary outcome
Evaluate the social cognition capacities
Time frame: One day
Evaluate the social cognition capacities of patients with Amyotrophic Lateral Sclerosis compared to control subjects using dynamic social cognition tests : Movie for the Assessment of Social Cognition. The maximum score is 48 points. The higher the score for correct answers, the better the performance.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Derived from this study: PubMed 40617623Faure-de Baets J, Besnard J, Cassereau J, Emmelin E, Allain P. Assessment of social cognition in patients with amyotrophic lateral sclerosis: protocol for a cross-sectional comparative study at Angers University Hospita. BMJ Open. 2025 Jul 5;15(7):e097543. doi: 10.1136/bmjopen-2024-097543.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared later upon request (e.g., the CRF to allow a collaborator to select the data to which they wish to have access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the MIVAR investigator, based on a protocol provided by the applicant, after verification of obtaining regulatory authorizations, including the favorable opinion of an ethics committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuropsychological test in people with Social Cognition, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the social cognition capacities (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04406675, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.