Antibody-mediated NMDA Receptor Encephalitis: Symptoms, Biomarkers, and Mechanisms of the Prolonged Recovery Stage (AMENDS)

Fundacion Clinic per a la Recerca Biomédica

Status: Enrolling

Conditions: Anti-NMDA Receptor Encephalitis

Treatments: Behavioral: Remote cognitive rehabilitation program

Study type: Interventional

Funder types: Other

Identifiers

NCT06183788

HR22-00221

Details and patient eligibility

About

The encephalitis mediated by antibodies against the NMDA receptor (NMDARe) predominantly affects young adults and children resulting in severe neurologic and psychiatric deficits. After overcoming the acute stage, patients are left with long-lasting behavioral, cognitive, and psychiatric alterations with important socio-family-economical implications. Here investigators postulate that a better knowledge of this stage will improve treatment decisions and outcome.

In Aim 1, the post-acute stage will be clinically characterized, tools to remotely follow cognitive, behavioral and psychiatric deficits will be provided, and the impact of cognitive rehabilitation will be assessed.

In Aim 2, biomarkers (autoimmune, inflammatory, neuronal injury) will be identified as signatures of the acute and post-acute stages.

In Aim 3, a mouse model of NMDARe will be used to determine the underlying mechanisms and treatment of the postacute stage.

Enrollment: 20 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients ≥12 years old with NMDARe in the post-acute stage of the disease;
• ≤6 months from hospital discharge (acute phase)

Exclusion Criteria (one of the following):

• Inability to obtain informed consent;
• inability to travel to the center.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Anti-NMDARe patients with remote cognitive rehabilitation

Experimental group

Description:

Participants of a prospective cohort in post-acute phase of the Antibody-mediated NMDA Receptor Encephalitis that will received a behavioral treatment.

Treatment:

Behavioral: Remote cognitive rehabilitation program