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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03518073 | A Study of LY3303560 in Participants With Early Symptomatic Alzheimer's Disease | PHASE2 | COMPLETED | 360 | — | — | Apr 30, 2018 | Oct 25, 2021 | Aug 30, 2022 | 60 | United States, Canada +1 |
Integrated Alzheimer's Disease Rating Scale (iADRS) is a simple linear combination of scores from 13-item alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog13) and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). It is used to assess whether zagotenemab slows down the cognitive and functional decline associated with early symptomatic Alzheimer's Disease, compared to placebo. The iADRS score ranges from 0 to 144 with lower scores indicating worse performance and higher score better performance. Change from baseline was calculated using Bayesian disease progression model (DPM) with fixed, categorical effects of treatment, pooled site, acetylcholinesterase inhibitor (AChEI) use at baseline (yes/no), and the continuous effects of baseline score and age at baseline. Data presented are posterior mean with 95% credible interval.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received intravenous (IV) infusion of placebo once every four weeks (Q4W) for 100 weeks. |
| Zagotenemab 1400 mg | EXPERIMENTAL | Participants received IV infusion of 1400 milligram (mg) zagotenemab Q4W for 100 weeks. |
| Zagotenemab 5600 mg | EXPERIMENTAL | Participants received IV infusion of 5600 mg zagotenemab Q4W for 100 weeks. |
| Name | Type | Description |
|---|---|---|
| Zagotenemab | DRUG | Administered IV |
| Placebo | DRUG | Administered IV |
Inclusion Criteria: * Participants must have gradual and progressive change in memory function for \>6 months. * Participants must have a family member or close friend who is with you at least 10 hours per week and can attend study appointments. Exclusion Criteria: * Participants must not have si...