Autoimmune EncephalitisSAPIENCE2NCT06609044
Long-term Impact of NMDAR Encephalitis
An observational study of Autoimmune Encephalitis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
NMDA receptor antibody encephalitis is a rare autoimmune neurological disease of the central nervous system with an estimated incidence of 1.5 people per million per year. Patients with anti-NMDAR encephalitis experience an acute phase of the disease characterized by psychosis, memory loss, seizures, autonomic nervous… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Autoimmune Encephalitis
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 16 Dec 2024to 4 Apr 2025
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with anti-NMDA encephalitis aged over 18 years old and followed in Lyon. We plan to include 30 patients.
Who may be able to join
- Patients with NMDAR encephalitis
- Age ≥ 18 years old
- Patient affiliated to a social security system
- No opposition from the patient
Who cannot join
- Patients whithout NMDAR encephalitis
- Age \< 18 years old
- Patient under guardianship or curatorship
- Patient with neurological disorders pre-existing encephalitis
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de référence des syndromes neurologies paranéoplasiques et encéphalites auto-immunes - Hôpital neurologiques Pierre WERTHEIMER
Bron, 69500
About this study
Official title: Social and Psychological Long-term Impact of NMDA Receptor Encephalitis
NMDA receptor antibody encephalitis is a rare autoimmune neurological disease of the central nervous system with an estimated incidence of 1.5 people per million per year. Patients with anti-NMDAR encephalitis experience an acute phase of the disease characterized by psychosis, memory loss, seizures, autonomic nervous system instability, or coma. Since the discovery of this disease 14 years ago by Prof. Dalmau, the clinical presentation of the acute phase has been well characterized, while the psychosocial impact of the disease remains largely unexplored.
Currently, there are few cohort studies of patients that have identified persistent cognitive impairment as a factor impacting remission after the acute phase. Given the scarcity of information concerning the post-acute phase, it is therefore essential to determine the long-term social and psychological outcomes and their daily effects on the social and functional life of this severe disease. This is especially important as the patients are young, with a median age of 21 years, and may face lasting limitations potentially detrimental to their success in professional, educational, or social environments.
Read the detailed description
This study will help improve the management of patients with anti-NMDAR encephalitis :
- By providing the first assessment of long-term cognitive, psychological and social consequences
- By characterizing the patient's journey through the disease
- By developing a standardized neuropsychological assessment which will improve the assessment of the patient in the post-acute phase As well as improving patient care in the long term through the drafting of specific medical recommendations.
- Conditions
- Autoimmune Encephalitis
- Keywords
- NMDAR encephalitis, psychosocial impact
- Medical subject headings
- Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anti-NMDAR encephalitis patients. | Patients over 18 years old with NMDAR encephalitis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease.
Neuropsychological Questionnaires :
- RAVLT questionnaire (no score)
- EMPAN questionnaire (no score)
Measured: 50 MINUTES
Analysis of cognitive assessments of patients with anti-NMDAR encephalitis after the acute phase of the disease.
Score of PROMs questionnaires :
- FSS (score : /63)
- HADS (score : /42)
- EQ5D5L (score : /100)
- BDI-II (no score )
- MMQ (no score)
- PSQI (no score)
Measured: 40 MINUTES
Patient's experience of the disease
Score of Clinical questionnaire about patient's experience of the disease
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start16 Dec 2024
- Primary completion4 Apr 2025
- Study completion4 Apr 2025
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 Autoimmune EncephalitisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme HONNORAT, MD, Principal investigator, Centre de référence des syndromes neurologies paranéoplasiques et encéphalites auto-immunes - Hôpital neurologiques Pierre WERTHEIMER - Groupement hospitalier Est - Hospices civiles de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609044
- Sponsor's protocol ID
- 69HCL24_0793
- Other IDs
- 2024-A01958-39
- Acronym
- SAPIENCE2
- Status last verified
- Dec 2025
- First submitted
- 6 Sep 2024
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boeken OJ, Heine J, Duda-Sikula M, Patricio V, Picard G, Buttard C, Benaiteau M, Mendes A, Howard F, Easton A, Kurpas D, Honnorat J, Dalmau J, Finke C. Assessment of long-term psychosocial outcomes in N-methyl-D-aspartate receptor encephalitis - the SAPIENCE study protocol. BMC Neurol. 2024 Sep 6;24(1):322. doi: 10.1186/s12883-024-03842-6.
PubMed 39242986
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social and Psychological Long-term Impact of NMDA Receptor Encephalitis
- ClinicalTrials.gov ID
- NCT06609044
- Acronym / sponsor ID
- SAPIENCE2 / 69HCL24_0793
- Conditions
- Autoimmune Encephalitis
- Keywords
- NMDAR encephalitis, psychosocial impact
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 23 Sep 2024 (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.
NMDA receptor antibody encephalitis is a rare autoimmune neurological disease of the central nervous system with an estimated incidence of 1.5 people per million per year. Patients with anti-NMDAR encephalitis experience an acute phase of the disease characterized by psychosis, memory loss, seizures, autonomic nervous system instability, or coma. Since the discovery of this disease 14 years ago by Prof. Dalmau, the clinical presentation of the acute phase has been well characterized, while the psychosocial impact of the disease remains largely unexplored.
Currently, there are few cohort studies of patients that have identified persistent cognitive impairment as a factor impacting remission after the acute phase. Given the scarcity of information concerning the post-acute phase, it is therefore essential to determine the long-term social and psychological outcomes and their daily effects on the social and functional life of this severe disease. This is especially important as the patients are young, with a median age of 21 years, and may face lasting limitations potentially detrimental to their success in professional, educational, or social environments.
Detailed description
This study will help improve the management of patients with anti-NMDAR encephalitis :
- By providing the first assessment of long-term cognitive, psychological and social consequences
- By characterizing the patient's journey through the disease
- By developing a standardized neuropsychological assessment which will improve the assessment of the patient in the post-acute phase As well as improving patient care in the long term through the drafting of specific medical recommendations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-NMDAR encephalitis patients. | – | –Patients over 18 years old with NMDAR encephalitis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with anti-NMDA encephalitis aged over 18 years old and followed in Lyon. We plan to include 30 patients.
Key inclusion criteria (4 listed)
- Patients with NMDAR encephalitis
- Age ≥ 18 years old
- Patient affiliated to a social security system
- No opposition from the patient
Key exclusion criteria (4 listed)
- Patients whithout NMDAR encephalitis
- Age \< 18 years old
- Patient under guardianship or curatorship
- Patient with neurological disorders pre-existing encephalitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease.
Time frame: 50 MINUTES
Neuropsychological Questionnaires : * RAVLT questionnaire (no score) * EMPAN questionnaire (no score)
Analysis of cognitive assessments of patients with anti-NMDAR encephalitis after the acute phase of the disease.
Time frame: 40 MINUTES
Score of PROMs questionnaires : * FSS (score : /63) * HADS (score : /42) * EQ5D5L (score : /100) * BDI-II (no score ) * MMQ (no score) * PSQI (no score)
Patient's experience of the disease
Time frame: 1 Year
Score of Clinical questionnaire about patient's experience of the disease
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 23 Dec 2025.
- Results publication: PubMed 39242986Boeken OJ, Heine J, Duda-Sikula M, Patricio V, Picard G, Buttard C, Benaiteau M, Mendes A, Howard F, Easton A, Kurpas D, Honnorat J, Dalmau J, Finke C. Assessment of long-term psychosocial outcomes in N-methyl-D-aspartate receptor encephalitis - the SAPIENCE study protocol. BMC Neurol. 2024 Sep 6;24(1):322. doi: 10.1186/s12883-024-03842-6.
- Individual participant dataSharing planned: No
Related trials for Autoimmune Encephalitis
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)
Progressive Multifocal Leukoencephalopathy
RecruitingPhase 2
A Study in Participants With Anti-NMDAR Encephalitis and Anti-NMDAR Autoantibody-Associated Psychiatric Disease
Anti-N-methyl-D-aspartate Receptor (NMDAR) Encephalitis (ANRE), Anti-N-methyl-D-aspartate Receptor (NMDAR) Antibody-associated Psychiatric Disease
Not yet recruitingPhase 1/2
A Safety and Efficacy Study Evaluating CTX112 in Subjects With Refractory Neurologic Autoimmune Disease
Progressive Multiple Sclerosis (PMS), Neuromyelitis Optica
Recruiting
OPM- MEG in Non-immune And iMmune-medIated Neurological Disease
Autoimmune Encephalitis (AE), Acute Disseminated Encephalomyelitis
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.
Jérôme HONNORAT, MD principal investigator
Centre de référence des syndromes neurologies paranéoplasiques et encéphalites auto-immunes - Hôpital neurologiques Pierre WERTHEIMER - Groupement hospitalier Est - Hospices civiles de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Encephalitis, run by Hospices Civils de Lyon 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 4 inclusion and 4 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 23 Dec 2025. 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?
Psychosocial questionnaires of patients with anti-NMDAR encephalitis after the acute phase of the disease. (time frame: 50 MINUTES). The study lists 3 primary outcomes in all. 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 NCT06609044, 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 23 Dec 2025.