NCT06321588 Autoimmune Dementia: Predictors of Neuronal Synaptic Antibodies in Patients With New-ONset Cognitive Impairment
| NCT ID | NCT06321588 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Usl di Bologna |
| Condition | Cognitive Impairment |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-05-10 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2023-05-10 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Maria Pia Giannoccaro, Dr.
PRINCIPAL INVESTIGATOR
IRCCS Istituto delle Scienze Neurologiche di Bologna
Frequently Asked Questions
Who can join the NCT06321588 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 90 Years, studying Cognitive Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06321588 currently recruiting?
Yes, NCT06321588 is actively recruiting participants. Contact the research team at mariapia.giannoccaro@ausl.bologna.it for enrollment information.
Where is the NCT06321588 trial being conducted?
This trial is being conducted at Bologna, Italy, Milan, Italy, Milan, Italy.
Who is sponsoring the NCT06321588 clinical trial?
NCT06321588 is sponsored by Azienda Usl di Bologna. The principal investigator is Maria Pia Giannoccaro, Dr. at IRCCS Istituto delle Scienze Neurologiche di Bologna. The trial plans to enroll 300 participants.