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LY451395 · 2 trials · 1 indication
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...
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LY451395 is an investigational small molecule being studied for the treatment of Alzheimer's Disease. It has been evaluated in Phase 2 clinical trials, including studies focused on efficacy and safety in patients with probable Alzheimer's Disease, as well as for aggression and agitation in Alzheimer's patients.
LY451395 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company has sponsored Phase 2 clinical trials to evaluate the drug's effects in patients with Alzheimer's Disease.
LY451395 is in Phase 2 clinical development. Two Phase 2 trials have been completed, with a total enrollment of 332 participants. The drug is investigational and has not been approved by regulatory authorities, as it remains in the clinical development stage.
LY451395 has been studied in two completed Phase 2 trials. NCT00051909 evaluated efficacy and safety in 200 patients with probable Alzheimer's Disease, while NCT00843518 assessed treatment for aggression and agitation in 132 Alzheimer's patients. Both trials were conducted in the United States.
LY451395 is not FDA approved. It is an investigational drug that has completed Phase 2 clinical trials for Alzheimer's Disease, but it has not received marketing authorization. The drug remains in clinical development and has not been approved for any use.