Hallucinations and Delusions Associated with Alzheimer’s Disease Psychosis
Conditions
Brief summary
Change from Baseline to Week 7 in the NPI-C H+D score
Detailed description
Change from Baseline to Week 7 in the CGI-S hallucinations and delusions domain-specific score, Change from Baseline to Week 7 in the NPI-C A+A score in participants who have a CGI-S agitation/aggression domain-specific score of ≥4 at Baseline, CGI-C hallucinations and delusions domain-specific score at Week 7, Change from Baseline to Week 7 on the NPI-C Hallucinations score, Change from Baseline to Week 7 on the NPI-C Delusions score, NPI-C H+D response, defined as ≥30% decrease in NPI-C H+D score at Week 7 relative to Baseline, Change from Baseline to Week 7 on the caregiver distress score of the hallucinations + delusions domains of the NPI-C
Interventions
DRUGPlacebo for ML-007C-MA bilayer tablet
Sponsors
Maplight Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline to Week 7 in the NPI-C H+D score | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline to Week 7 in the CGI-S hallucinations and delusions domain-specific score, Change from Baseline to Week 7 in the NPI-C A+A score in participants who have a CGI-S agitation/aggression domain-specific score of ≥4 at Baseline, CGI-C hallucinations and delusions domain-specific score at Week 7, Change from Baseline to Week 7 on the NPI-C Hallucinations score, Change from Baseline to Week 7 on the NPI-C Delusions score, NPI-C H+D response, defined as ≥30% decrease in NPI-C H+D score at Week 7 relative to Baseline, Change from Baseline to Week 7 on the caregiver distress score of the hallucinations + delusions domains of the NPI-C | — |
Countries
Bulgaria, Czechia, France, Hungary, Italy, Poland, Portugal, Romania, Slovakia
Outcome results
None listed