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Also known as [¹⁴C]-LY3372689
LY3372689 · 1 trial · 1 indication
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 LY3372689 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) adjusted for age at baseline, AChEI/Memantine use at baseline, pooled investigator. Data presented are posterior mean with 95% credible interval.
| Arm | Type | Description |
|---|---|---|
| 0.75 Milligram (mg) LY3372689 | EXPERIMENTAL | Double-blind treatment period: Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks. Post treatment follow up period: Participants who received 0.75 mg LY3372689 during the double-blind treatment period entered a post-treatment follow-up period for 4 weeks after last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety monitoring. Post treatment observational extension period: Participants who received 0.75 mg LY3372689 during the double-blind treatment period had the option to enter post-treatment observational extension period for approximately 9 months on average since last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety, other/exploratory efficacy and biomarker monitoring. |
| 3 mg LY3372689 | EXPERIMENTAL | Double-blind treatment period: Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks. Post treatment follow up period: Participants who received 3 mg LY3372689 during the double-blind treatment period entered a post-treatment follow-up period for 4 weeks after last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety monitoring. Post treatment observational extension period: Participants who received 3 mg LY3372689 during the double-blind treatment period had the option to enter post-treatment observational extension period for approximately 9 months on average since last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety, other/exploratory efficacy and biomarker monitoring. |
| Placebo | PLACEBO_COMPARATOR | Double-blind treatment period: Participants received placebo administered orally once daily for up to 124 weeks. Post treatment follow up period: Participants who received placebo during the double-blind treatment period entered a post-treatment follow-up period for 4 weeks after last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety monitoring. Post treatment observational extension period: Participants who received placebo during the double-blind treatment period had the option to enter post-treatment observational extension period for approximately 9 months on average since last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety, other/exploratory efficacy and biomarker monitoring. |
| Name | Type | Description |
|---|---|---|
| LY3372689 | DRUG | given orally |
| Placebo | DRUG | given orally |
Inclusion Criteria: * Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months * MMSE score of 22 to 30 (inclusive) at screening * CDR global score of 0.5 to 1.0 (inclusive), with a memory box score ≥0.5. * Meet 18F flortaucipir positron emission tomog...
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LY3372689 is an investigational small molecule developed by Eli Lilly and Company for Alzheimer disease. It is a Phase 2 clinical candidate in the neurology therapeutic area. A radiolabeled version, [¹⁴C]-LY3372689, has also been used. It has been studied in one completed Phase 2 trial enrolling 327 participants.
LY3372689 is being developed as a treatment for Alzheimer disease. Its only clinical trial, NCT05063539, evaluated safety, tolerability, and efficacy in participants with Alzheimer disease. That Phase 2 study is completed, and the drug remains investigational rather than approved for any use.
LY3372689 is made and developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored the Phase 2 study of the compound in Alzheimer disease.
LY3372689 is in Phase 2 development. Its single trial, NCT05063539, was a Phase 2 study that has completed. The drug is investigational and has not been approved by the FDA for Alzheimer disease or any other indication.
LY3372689 has been studied in one clinical trial, NCT05063539, titled A Study of LY3372689 to Assess the Safety, Tolerability, and Efficacy in Participants With Alzheimer's Disease. It was a completed Phase 2, randomized, double-blind, placebo-controlled trial with 327 participants across the United States, Australia, Canada, Japan, and Poland.
Yes. [¹⁴C]-LY3372689 is an alternative name for LY3372689, referring to a carbon-14 radiolabeled form of the same compound. Searches for either name refer to the Eli Lilly small molecule studied in Alzheimer disease under the trial identifier NCT05063539.