Autoimmune Dementia: Predictors of Neuronal Synaptic Antibodies in Patients With New-ONset Cognitive Impairment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-90
SponsorAzienda Usl di Bologna
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
patients with a diagnosis of new-onset neurocognitive disorders (major and minor)
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 2 trial groupsGroup A: retrospective cohort
Group B: prospective cohort
Trial outcomes
Primary outcomes
1
frequency of antibodies against neuronal antigens
NSAb frequency will be calculated by dividing the number of patients with NSAb with the total number of patients
Time frame
at baseline2
frequency of antibodies against neuronal antigens
NSAb frequency will be calculated by dividing the number of patients with NSAb with the total number of patients
Time frame
12 months (54 weeks)3
creation of a score that predicts the presence of NSAb
Based on logistic regression models including the clinical, imaging and biomarkers data. The minimum and maximum score is to be defined on the bases of the analyses of the clinical data at 24 months milestone.An higher score is expected to be associated with the antibody presence.
Time frame
24 months (108 weeks)Secondary outcomes
1
changes of neurodegeneration biomarkers
comparison of blood biomarkers from baseline to one year follow up in seropositive versus seronegative patients. The blood biomarkers are: phosphorylated tau protein 181 (p-tau 181) (pg/mL), Neurofilament Light chain (NfL) (pg/mL), Glial Fibrillary Acidic Protein (GFAP) (pg/mL).
Time frame
at baseline2
changes of neurodegeneration biomarkers
comparison of blood biomarkers from baseline to one year follow up in seropositive versus seronegative patients. The blood biomarkers are: phosphorylated tau protein 181 (p-tau 181) (pg/mL), Neurofilament Light chain (NfL) (pg/mL), Glial Fibrillary Acidic Protein (GFAP) (pg/mL).
Time frame
1 year (54 weeks)3
changes of neuroanatomy
comparison of Brain MRI from baseline to one year follow up in seropositive versus seronegative patients
Time frame
at baseline4
changes of neuroanatomy
comparison of Brain MRI from baseline to one year follow up in seropositive versus seronegative patients
Time frame
1 year (54 weeks)Sponsors and contacts
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Source ClinicalTrials.gov