Autoimmune Dementia: Predictors of Neuronal Synaptic Antibodies in Patients With New-ONset Cognitive Impairment

Recruiting now

Conditions studied: Cognitive Impairment, Dementia

In brief

The goal of this observational study is to investigate the frequency and the possible pathogenic role of neuronal synaptic antibodies (NSAb) in patients with cognitive impairment (CI). The main questions it aims to answer are: 1. the frequency and associated features of NSAb in patients with CI and the usefulness of a clinical score in improving autoimmune dementia (AID) diagnosis; 2. the clinical significance of NSAb in patients with CI not fulfilling the autoimmune encephalitis (AE) criteria and serum NSAb (NSAb-pos-CI); 3. the impact of blood-brain-barrier (BBB) dysfunction on their pathogenicity.

Key facts

Study ID

NCT06321588

Run by

Azienda Usl di Bologna

People needed

300

Starts

2023-05-10

Expected to finish

2026-06-30

Last updated by the study team

2026-02-11

Who can join

Age: 40 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• both sexes
• adult (aged between 40 and 90 years)
• patients with a diagnosis of new-onset neurocognitive disorders (major and minor), as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, with onset within the previous 24 months

You may not qualify if…

• presence of a history of seizures within 4 weeks from onset.

Where it is running

• IRCCS Istituto delle Scienze Neurologiche di Bologna — Bologna, Bologna, Italy (enrolling)
• Istituto Auxologico Italiano IRCCS — Milan, Milano, Italy (enrolling)
• Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan, Milano, Italy (enrolling)

Full record on ClinicalTrials.gov

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