Phase 2/3, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Participants with Alzheimer’s Disease Dementia

Agitation in Alzheimer's Disease Dementia

Difference between active and placebo as measured by changes from baseline to endpoint (Week 6) in the Cohen-Mansfield Agitation Inventory total score

EXV-802: Difference between active and placebo as measured by changes from baseline to endpoint (Week 6) in the Clinical Global Impression of Severity of Illness (CGI-S) score, as related to symptoms of agitation., EXV-802: Difference between active and placebo as measured by changes from baseline to endpoint (Week 6) in the NPI-C Caregiver Distress total score for agitation and aggression., EXV-802: Difference between active and placebo as measured by changes from baseline to endpoint (Week 6) in the NPI-C Irritability / Lability score., EXV-802: Difference between active and placebo as measured by changes from baseline to endpoint (Week 6) in the NPI-C Sleep Disorders score., EXV-802: Difference between active and placebo in frequency and severity of adverse events and clinically relevant changes in relevant safety endpoints e.g.: • Mini‐Mental State Examination (MMSE) • Columbia Suicide Severity Rating Scale (C-SSRS) score • Clinical laboratory values • Vital signs • Electrocardiograms (ECGs) • Physical examination findings, EXV-801: Difference between active and placebo as measured by changes from baseline to endpoint (Week 6) in CMAI, CGI-S, NPI-C, exploratory PD markers (BDNF), and blood-based biomarkers (analysis limited to descriptive statistics, including the effect size)., EXV-801: Difference between active and placebo in frequency and severity of adverse events and clinically relevant changes in relevant safety endpoints e.g.: • Mini‐Mental State Examination (MMSE) • Columbia Suicide Severity Rating Scale (C-SSRS) score • Clinical laboratory values • Vital signs • Electrocardiograms (ECGs) • Physical examination findings

No related papers found yet.