Hallucinations and Delusions Associated with Alzheimer’s Disease Psychosis
Conditions
Brief summary
Incidence of TEAEs, treatment-emergent SAEs, and TEAEs leading to study discontinuation
Detailed description
Safety: • Observed values and changes from OL Baseline in clinical safety laboratory assessments, 12-lead ECG parameters, vital sign parameters, and body weight • GCAS score • Changes from OL Baseline in ESRS-A score • Changes from OL Baseline in MMSE score, Effectiveness: Changes from OL Baseline in the following: • NPI-C H+D score • CGI-S hallucinations and delusions domain-specific score • NPI-C A+A score in participants who had a CGI-S agitation and aggression domain-specific score of ≥4 at OL Baseline • ADCS-ADL total score, Effectiveness: Changes from OL Baseline in ZBI-12 score, Pharmacokinetic: Plasma concentrations of ML-007 (and its major metabolites, if applicable)
Interventions
None listed
Sponsors
Maplight Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of TEAEs, treatment-emergent SAEs, and TEAEs leading to study discontinuation | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: • Observed values and changes from OL Baseline in clinical safety laboratory assessments, 12-lead ECG parameters, vital sign parameters, and body weight • GCAS score • Changes from OL Baseline in ESRS-A score • Changes from OL Baseline in MMSE score, Effectiveness: Changes from OL Baseline in the following: • NPI-C H+D score • CGI-S hallucinations and delusions domain-specific score • NPI-C A+A score in participants who had a CGI-S agitation and aggression domain-specific score of ≥4 at OL Baseline • ADCS-ADL total score, Effectiveness: Changes from OL Baseline in ZBI-12 score, Pharmacokinetic: Plasma concentrations of ML-007 (and its major metabolites, if applicable) | — |
Outcome results
None listed