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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03019536 | A Study of LY3303560 in Participants With Mild Cognitive Impairment or Alzheimer's Disease | PHASE1 | COMPLETED | 22 | — | — | Jan 31, 2017 | Jun 5, 2019 | Oct 10, 2023 | 11 | United States, Japan +1 |
A summary of other non-serious adverse events (AEs), and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
| Arm | Type | Description |
|---|---|---|
| 70 mg LY3303560 | EXPERIMENTAL | 70 milligram (mg) LY3303560 administered intravenously (IV) every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up to 6 further doses), followed by a 16-week follow-up period. |
| 210 mg LY3303560 | EXPERIMENTAL | 210 mg LY3303560 administered IV every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up to 6 further doses), followed by a 16-week follow-up period. |
| Placebo IV | EXPERIMENTAL | Placebo administered intravenously (IV) every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up to 6 further doses),, followed by a 16-week follow-up period. |
| Name | Type | Description |
|---|---|---|
| LY3303560 - IV | DRUG | Administered IV |
| Placebo - IV | DRUG | Administered IV |
| Florbetapir F 18 | DRUG | Administered IV during the Positron Emission Tomography (PET) scan performed during screening. |
| Flortaucipir F18 | DRUG | Administered IV during the PET scan performed during the study. |
Inclusion Criteria: * Mild Cognitive Impairment (MCI) due to Alzheimer's Disease (AD) or mild-to-moderate AD based on National Institute of Aging and Alzheimer's Association diagnostic criteria * Female participants: women not of child-bearing potential may participate, and include those who are: ...