Agitation with Dementia of the Alzheimer's Type
Conditions
Brief summary
Change in CMAI items score aligning to the IPA agitation criteria domains from baseline to Week 12
Detailed description
Improvement in mADCS-CGI-C at Week 12, Change in CGI-S score as related to agitation from baseline to Week 12, Change in CaGI-S score as related to agitation from baseline to Week 12, Improvement in CaGI-C at Week 12, Change in behavioral and psychological symptoms as measured by NPI-12 from baseline to Week 12, Change in memory and cognitive behaviors as studied using MMSE total score from baseline to Week 12, Change in CMAI items score aligning to the IPA agitation criteria domains from baseline to Weeks 2, 4, and 8, Change in C-SDD from baseline to Week 12
Interventions
DRUGPL1
DRUGMasupirdine
Sponsors
Suven Life Sciences Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in CMAI items score aligning to the IPA agitation criteria domains from baseline to Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in mADCS-CGI-C at Week 12, Change in CGI-S score as related to agitation from baseline to Week 12, Change in CaGI-S score as related to agitation from baseline to Week 12, Improvement in CaGI-C at Week 12, Change in behavioral and psychological symptoms as measured by NPI-12 from baseline to Week 12, Change in memory and cognitive behaviors as studied using MMSE total score from baseline to Week 12, Change in CMAI items score aligning to the IPA agitation criteria domains from baseline to Weeks 2, 4, and 8, Change in C-SDD from baseline to Week 12 | — |
Countries
Croatia, Poland
Outcome results
None listed