There is one clinical trial.
A pilot study of the effects of Bacillus Calmette-Guérin (BCG) immunization on cerebrospinal fluid and blood-based biomarkers in older adults.
Description: Change in concentration of circulating cytokines in CSF from baseline
Measure: CSF biomarkers of pharmacodynamic response- cytokines Time: Day 84Description: Change in Treg number and proportion relative to total CD4+ and CD8+ T cells in CSF from baseline
Measure: CSF biomarkers of pharmacodynamic response-Treg Time: Day 84Description: Change in soluble TNF receptor (sTNF-R) concentration in CSF from baseline
Measure: CSF biomarkers of pharmacodynamic response-TNFR Time: Day 84Description: Change in concentration of ATN markers of AD pathophysiology (Amyloid-β42/40, phospho-tau, total tau and neurofilament light protein biomarkers) in CSF from baseline.
Measure: CSF biomarkers of AD pathology-ATN Time: Day 84Description: Change in BCG on molecular markers of immune response (YKL40, and sTREM2) concentration from from Baseline.
Measure: CSF biomarkers of immune response. Time: Day 84Description: Change in concentration of circulating cytokines in blood from baseline.
Measure: Blood biomarkers of pharmacodynamic response- cytokines Time: Day 28Description: Change in concentration of Treg number and proportion (relative to total CD4+ and CD8+ T cells) in blood from baseline.
Measure: Blood biomarkers of pharmacodynamic response-Treg Time: Day 28Description: Change in concentration of Soluble TNF receptor (sTNF-R) in blood from baseline.
Measure: Blood biomarkers of pharmacodynamic response-TNFR Time: Day 28Description: Change in concentration of circulating cytokines in blood from baseline
Measure: Blood biomarkers of pharmacodynamic response- cytokines Time: Day 84Description: Change in Treg number and proportion relative to total CD4+ and CD8+ T cells in blood from baseline
Measure: Blood biomarkers of pharmacodynamic response- Treg Time: Day 84Description: Change in soluble TNF receptor (sTNF-R) concentration in blood from baseline
Measure: Blood biomarkers of pharmacodynamic response- TNFR Time: Day 84Description: Change in concentration of ATN markers of AD pathophysiology (Amyloid-β42/40, phospho-tau, total tau and neurofilament light protein biomarkers) in blood from baseline.
Measure: Blood biomarkers of AD pathology Time: Day 28Description: Change in concentration of ATN markers of AD pathophysiology (Amyloid-β42/40, phospho-tau, total tau and neurofilament light protein biomarkers) in blood from baseline.
Measure: Blood biomarkers of AD pathology Time: Day 84Description: Change from baseline in Clinical Dementia Rating Sum-of-Boxes (CDR-SOB) score. Score range= 0-18 (0=unimpaired, 18=severe dementia)
Measure: Cognitive Measures (CDR) Time: Day 28Description: Change from baseline in Clinical Dementia Rating Sum-of-boxes (CDR-SOB) score. Score range= 0-18 (0=unimpaired, 18=severe dementia)
Measure: Cognitive Measures (CDR) Time: Day 84Description: Change from baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score.
Measure: Cognitive Measures (RBANS) Time: Day 28Description: Change from baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score
Measure: Cognitive Measures (RBANS) Time: Day 84