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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06297590 | A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease | PHASE1 | RECRUITING | 48 | — | — | Aug 15, 2024 | Feb 1, 2027 | Apr 20, 2026 | 10 | United States, Japan +1 |
A summary of AEs, TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module
A summary of AEs, TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module
| Arm | Type | Description |
|---|---|---|
| LY3954068 (Part A) | EXPERIMENTAL | Single ascending dose of LY3954068 administered intrathecally (IT) |
| Placebo (Part A) | PLACEBO_COMPARATOR | Single ascending dose of placebo administered IT |
| LY3954068 (Part B) | EXPERIMENTAL | Multiple ascending dose of LY3954068 administered IT |
| Placebo (Part B) | PLACEBO_COMPARATOR | Multiple ascending dose of placebo administered IT |
| Name | Type | Description |
|---|---|---|
| LY3954068 | DRUG | Administered IT |
| Placebo | DRUG | Administered IT |
| Flortaucipir F18 | DRUG | Administered intravenously (IV) prior to Positron Emission Tomography (PET) scan |
Inclusion Criteria: * Have a body mass index (BMI) within the range 18 to 40 kilograms per square meter (kg/m²), inclusive, at screening. * Have gradual and progressive change in memory function for greater than or equal to (≥) 6 months as reported by the participant or informant. * Have a mini men...