Investigating Neuronal Antibodies in Patients with Cognitive Impairment
Autoimmune Dementia: Predictors of Neuronal Synaptic Antibodies in Patients With New-ONset Cognitive Impairment and Their Relevance in Non-encephalitic formS: The ADONIS Study
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 40 Years to 90 Years |
| Sex | All |
| Sponsor | Azienda Usl di Bologna Government |
| Locations | 3 sites (Bologna, Bologna and 2 other locations) |
| Trial ID | NCT06321588 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with a history of seizures within 4 weeks of onset will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bologna, Bologna and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.