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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06335173 | A Study to Evaluate Efficacy and Safety of Intravenous Sabirnetug in Participants With Early Alzheimer's Disease (ALTITUDE-AD) | PHASE2 | ACTIVE NOT_RECRUITING | 542 | — | — | Feb 29, 2024 | Oct 1, 2026 | Oct 27, 2025 | 68 | United States, Canada +3 |
| NCT06511570 | A Study Comparing the Safety, Tolerability, and Pharmacokinetics of Sabirnetug IV and Sabirnetug + rHuPH20 SC in Healthy Participants | PHASE1 | COMPLETED | 28 | — | — | Jun 25, 2024 | Sep 17, 2024 | Oct 18, 2024 | 1 | United States |
iADRS is a validated composite of cognition and function made up of Alzheimer's Disease Assessment Scale - Cognitive Subscale 13-item (ADAS-Cog13) and the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living scale (ADCS-iADL). ADAS-Cog13 is a rater-administered instrument consisting of 13 items assessing cognitive function areas most typically impaired in AD. ADAS-Cog13 scores range from 0 to 85, with higher scores indicating a greater deficit of global cognition. The ADCS-iADL is a subset of the 23-item ADCS-ADL (items 6a and 7 to 23). The iADLs are more complex skills required to successfully live independently. iADL-items score ranges from 0 to 59 (lower scores indicating greater impairment). The iADRS is calculated as a linear combination of total scores from the ADAS-Cog13 and ADCS-iADL. The iADRS score ranges from 0 to 144 with lower scores indicating worse performance.
Cmax (Maximum concentration, determined directly from individual concentration-time data)
Tmax (Time of the maximum concentration)
λz (The observed terminal rate constant; estimated by linear regression through at least three data points in the terminal phase of the log concentration-time profile)
T1/2 (The observed terminal half-life)
AUC168h (Area under the concentration-time curve during a one-week dosing interval)
AUClast (Area under the concentration-time curve from time zero to the time of the last quantifiable concentration; calculated using the linear trapezoidal rule)
AUCinf (Area under the concentration-time curve from time zero extrapolated to infinity)
AUCExtrap (%)(The percentage of AUCinf based on extrapolation)
Clast (The last quantifiable concentration determined directly from individual concentration-time data)
Tlast (Time of the last quantifiable concentration)
| Arm | Type | Description |
|---|---|---|
| Double-blind Treatment (DBT) Period: sabirnetug 35 mg/kg | EXPERIMENTAL | Participants will receive sabirnetug, 35 milligrams per kilogram (mg/kg), Q4W as intravenous (IV) infusion during the DBT period. |
| DBT Period: sabirnetug 50 mg/kg | EXPERIMENTAL | Participants will receive sabirnetug, 35 mg/kg, for the first two doses, followed by sabirnetug, 50 mg/kg, Q4W as an IV infusion during the DBT period. |
| DBT Period: Placebo | PLACEBO_COMPARATOR | Participants will receive sabirnetug matching placebo, Q4W as an IV infusion during the DBT period. |
| Open-Label Extension (OLE) Period: sabirnetug 35 mg/kg | EXPERIMENTAL | Participants will receive sabirnetug, 35 mg/kg, Q4W as an IV infusion during the OLE period. |
| Arm 1 | EXPERIMENTAL | 12 participants receive sabirnetug by intravenous infusion |
| Arm 2 | EXPERIMENTAL | 16 participants receive sabirnetug + rHuPH20 by subcutaneous injection |
| Name | Type | Description |
|---|---|---|
| sabirnetug | DRUG | Intravenous sabirnetug |
| Placebo | DRUG | Intravenous Placebo |
| sabirnetug (ACU193) | DRUG | sabirnetug by intravenous infusion |
| Sabirnetug + rHuPH20 | COMBINATION_PRODUCT | sabirnetug + rHuPH20 by subcutaneous injection |
Inclusion Criteria: * Body weight of at least 30 kilograms (kg) (66 pounds \[lbs\]) and no more than 160 kg (352 lbs) at Screening * Must consent to apolipoprotein E4 (APOE4) genotype status assessment * Must meet all of the following criteria 1. National Institute on Aging-Alzheimer's Associati...