Dementia Clinical Trial
— ADONISOfficial 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
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | June 30, 2026 |
Est. primary completion date | June 30, 2026 |
Accepts healthy volunteers | |
Gender | All |
Age group | 40 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Istituto delle Scienze Neurologiche di Bologna | Bologna | |
Italy | Fondazione IRCCS Istituto Neurologico Carlo Besta | Milano | |
Italy | Istituto Auxologico Italiano IRCCS | Milano |
Lead Sponsor | Collaborator |
---|---|
Azienda Usl di Bologna |
Italy,
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | at baseline | |
Primary | 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 | 12 months (54 weeks) | |
Primary | 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. | 24 months (108 weeks) | |
Secondary | 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). | at baseline | |
Secondary | 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). | 1 year (54 weeks) | |
Secondary | changes of neuroanatomy | comparison of Brain MRI from baseline to one year follow up in seropositive versus seronegative patients | at baseline | |
Secondary | changes of neuroanatomy | comparison of Brain MRI from baseline to one year follow up in seropositive versus seronegative patients | 1 year (54 weeks) | |
Secondary | changes of inflammatory biomarkers | comparison of inflammatory biomarkers from baseline to one year follow up in seropositive versus seronegative patients. The inflammatory biomarkers are: Interferon alpha (IFN alpha) (pg/mL), Interferon gamma (IFN gamma) (pg/mL), Interleukin-1 beta (IL-1 beta) (pg/mL), Interleukin-2 (IL-2) (pg/mL), Interleukin-4 (IL-4) (pg/mL), Interleukin-5 (IL-5) (pg/mL), Interleukin-6 (IL-6) (pg/mL), Interleukin-8 (IL-8) (pg/mL), Interleukin-17A (IL-17A) (pg/mL), Tumor necrosis factor alpha (TNF alpha) (pg/mL), Interferon gamma-induced protein 10 (IP-10) known as C-X-C motif chemokine 10(CXCL10) (pg/mL), Monocyte chemoattractant protein-1 (MCP-1) known as C-C motif chemokine ligand 2 (CCL2) (pg/mL). | at baseline | |
Secondary | changes of inflammatory biomarkers | comparison of inflammatory biomarkers from baseline to one year follow up in seropositive versus seronegative patients. The inflammatory biomarkers are: Interferon alpha (IFN alpha) (pg/mL), Interferon gamma (IFN gamma) (pg/mL), Interleukin-1 beta (IL-1 beta) (pg/mL), Interleukin-2 (IL-2) (pg/mL), Interleukin-4 (IL-4) (pg/mL), Interleukin-5 (IL-5) (pg/mL), Interleukin-6 (IL-6) (pg/mL), Interleukin-8 (IL-8) (pg/mL), Interleukin-17A (IL-17A) (pg/mL), Tumor necrosis factor alpha (TNF alpha) (pg/mL), Interferon gamma-induced protein 10 (IP-10) known as C-X-C motif chemokine 10(CXCL10) (pg/mL), Monocyte chemoattractant protein-1 (MCP-1) known as C-C motif chemokine ligand 2 (CCL2) (pg/mL). | 1 year (54 weeks) | |
Secondary | changes of brain blood barrier biomarkers | comparison of brain blood barrier biomarkers from baseline to one year follow up in seropositive versus seronegative patients. The biomarkers are: S100 calcium-binding protein B (S-100b) (pg/mL), Glial Fibrillary Acidic Protein (GFAP) (pg/mL). | at baseline | |
Secondary | changes of brain blood barrier biomarkers | comparison of brain blood barrier biomarkers from baseline to one year follow up in seropositive versus seronegative patients. The biomarkers are: S100 calcium-binding protein B (S-100b) (pg/mL), Glial Fibrillary Acidic Protein (GFAP) (pg/mL). | 1 year (54 weeks) |
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