Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00843518 | Treatment for Aggression and Agitation in Patients With Alzheimer's Disease | PHASE2 | COMPLETED | 132 | — | — | Feb 1, 2009 | Jun 1, 2011 | Nov 29, 2017 | 17 | United States |
| NCT00051909 | Efficacy and Safety of LY451395 in Patients With Probable Alzheimer's Disease | PHASE2 | COMPLETED | 200 | — | — | Nov 1, 2002 | Jun 1, 2003 | Jul 19, 2006 | 9 | United States |
NPI assessed noncognitive psychopathology in participants with Alzheimer's dementia. A 4-item subscale of the standard 12-item NPI measured the neuropsychiatric symptoms of A/A, with items consisting of agitation/aggression, aberrant motor behavior, irritability/emotional lability, and disinhibition. Scores for each subscale (frequency x severity) were calculated to obtain each item score. The total subscale score ranged from 0 to 48, with higher scores indicating more frequent and/or severe A/A symptoms. If a symptom was not present at all, the site would not enter anything for frequency or severity, and a zero would be imputed for that item. Least Squares (LS) Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline NPI-4 A/A, and baseline-by-visit interaction.
| Arm | Type | Description |
|---|---|---|
| LY451395 | EXPERIMENTAL | 3 milligram (mg) LY451395 orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate |
| Placebo | PLACEBO_COMPARATOR | Placebo orally twice daily for 12 weeks |
| Name | Type | Description |
|---|---|---|
| LY451395 | DRUG | 3 mg LY451395 orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate |
| Placebo | DRUG | Placebo orally twice daily for 12 weeks |
Inclusion Criteria: * Community-dwelling participants with a diagnosis of probable Alzheimer's disease (AD) based on disease criteria from the National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and the Alzheimer's Association. Mini Mental State Examination (MMSE) sco...