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

Study acronym: ADONIS
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Publications: details revised at 12 of 12 entriesv4
  2. Site details revised at 3 of 3 sites
    • Publications: details revised at 12 of 12 entries
    v3
  3. Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 6 of 8 entries
    • Study description expanded, about 7 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06321588
Lead Sponsor Azienda Usl di Bologna
Conditions
(from sponsor)		 Cognitive Impairment, Dementia
Related terms Cognitive Dysfunction, Dementia
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov