Clinical Trial

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

Study acronym: ADONIS
Recruiting
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Record status
This record was last updated February 11, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-03-19; most recent amendment 2026-02-09.
Trial Details
NCT Number NCT06321588
Lead Sponsor Azienda Usl di Bologna
Conditions Cognitive Impairment, Dementia
Enrollment 300 participants
Start Date 2023-05-10
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-11