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Also known as LY3303560
Zagotenemab · 3 trials · 3 indications
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.
A summary of other non-serious adverse events (AEs), and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Number of participants with one or more SAEs considered by the investigator to be related to study drug administration. A summary of other nonserious adverse events (AEs), and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
| 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. |
| 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. |
| LY3303560 | EXPERIMENTAL | Single IV infusion 7 milligram (mg), 21 mg, 70 mg, 210 mg, 700 mg, 1400 mg, 2800 mg, and 5600 mg of LY3303560 on Day 1 in healthy participants. |
| Saline Solution | PLACEBO_COMPARATOR | Single IV infusion of saline solution to match LY3303560 on Day 1 in healthy participants. |
| LY3303560 Subcutaneous (SC) | EXPERIMENTAL | Single SC injection of 210 mg LY3303560 on Day 1 in healthy participants. |
| Name | Type | Description |
|---|---|---|
| Zagotenemab | DRUG | Administered IV |
| Placebo | DRUG | Administered IV |
| 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. |
| Saline Solution - IV | DRUG | Administered IV |
| LY3303560 - SC | DRUG | Administered SC |
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...
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Zagotenemab is an investigational monoclonal antibody being studied for the treatment of Alzheimer disease. It was evaluated in a Phase 2 clinical trial in participants with early symptomatic Alzheimer disease. It is not approved for any indication and remains in clinical development.
Zagotenemab targets MAPT, the microtubule-associated protein tau. It is designed as an inhibitor of this target. Tau pathology is a hallmark of Alzheimer disease, and zagotenemab was developed to bind and neutralize tau species in the brain.
Zagotenemab is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. The company sponsored the Phase 2 clinical trial of the drug in Alzheimer disease.
Zagotenemab is in Phase 2 development. It is an investigational monoclonal antibody and has not been approved by the FDA for any indication. The Phase 2 trial has been completed, and no active trials are currently listed.
Zagotenemab was studied in the Phase 2 trial NCT03518073, titled A Study of LY3303560 in Participants With Early Symptomatic Alzheimer's Disease. The trial enrolled 360 participants, was randomized, double-blind, and placebo-controlled, and was conducted in the United States, Canada, and Japan.