Investigating Neuronal Antibodies in Patients with Cognitive Impairment
Official title: Autoimmune Dementia: Predictors of Neuronal Synaptic Antibodies in Patients With New-ONset Cognitive Impairment and Their Relevance in Non-encephalitic formS: The ADONIS Study
Run by Azienda Usl di Bologna · NCT06321588 · Data updated 2026-11-12
This study is trying to see how common certain antibodies are in people with cognitive impairment and if they play a role in their condition, especially for those who don't have autoimmune encephalitis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 40 Years to 90 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Azienda Usl di Bologna Government |
| Locations | 3 sites (Bologna, Bologna and 2 other locations) |
| Status | Recruiting |
| Started | May 10, 2023 |
| Main results expected | June 30, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | February 11, 2026 |
| Trial ID | NCT06321588 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 40 to 90 years with new-onset neurocognitive disorders diagnosed within the last 24 months.
✕Probably not a fit
Patients with a history of seizures within 4 weeks of onset will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the frequency and potential pathogenic role of neuronal synaptic antibodies (NSAb) in patients experiencing cognitive impairment. It seeks to determine the prevalence of NSAb in these patients and assess the clinical significance of NSAb in those who do not meet the criteria for autoimmune encephalitis. Additionally, the study will investigate the impact of blood-brain barrier dysfunction on the pathogenicity of these antibodies. By addressing these questions, the study aims to improve the diagnosis and management of autoimmune dementia.
Why it matters
Potential benefit: If successful, this study could lead to earlier identification and better management strategies for patients with autoimmune dementia.
How similar studies have gone: While data on the prevalence of NSAb in cognitive impairment patients is limited, this study addresses a significant gap in understanding and could provide novel insights into autoimmune dementia.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: \- presence of a history of seizures within 4 weeks from onset.
Where it's running
-
IRCCS Istituto delle Scienze Neurologiche di Bologna
Bologna, Bologna, Italy Recruiting -
Istituto Auxologico Italiano IRCCS
Milan, Milano, Italy Recruiting -
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Milano, Italy Recruiting
Study contacts
- Principal investigator: Maria Pia Giannoccaro, Dr. — IRCCS Istituto delle Scienze Neurologiche di Bologna
- Study coordinator: Maria Pia Giannoccaro, Dr.
- Email: mariapia.giannoccaro@ausl.bologna.it
- Phone: +390514966112
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.