A Study of Lanabecestat (LY3314814) in Participants With Mild Alzheimer's Disease Dementia
Summary
The main purpose of this study is to evaluate the efficacy of the study drug known as lanabecestat in participants with mild Alzheimer's disease (AD) dementia.
Timeline
- Start
- 2016-07-01
- Primary completion
- 2018-09-28
- Completion
- 2018-09-28
Outcome
Missed primary endpoint
Stopped: “An independent assessment concluded the trial was not likely to meet the primary endpoint upon completion and therefore, trial stopped for futility.”
registry analysis (superiority test); Placebo vs Lanabecestat 20 mg; p = 0.129; LS Mean Difference (Final Values) 2.51 (95% CI -0.752 to 5.776); Mixed Models Analysis NCT02783573 ↗
registry analysis (superiority test); Placebo vs Lanabecestat 50 mg; p = 0.903; LS Mean Difference (Final Values) -0.21 (95% CI -3.725 to 3.296); Mixed Models Analysis NCT02783573 ↗
paper There were no consistent, reproducible dose-related findings on primary or secondary efficacy measures. PMID 31764959 ↗
paper Treatment with lanabecestat was well tolerated and did not slow cognitive or functional decline. PMID 31764959 ↗
release “the AMARANTH trial, in early Alzheimer's disease, and the DAYBREAK-ALZ trial, in mild Alzheimer's disease dementia, were not likely to meet their primary endpoints” lilly.com ↗
Publications
- Wessels AM, Tariot PN, Zimmer JA, Selzler KJ, Bragg SM, Andersen SW, Landry J, Krull JH, Downing AM, Willis BA, Shcherbinin S, Mullen J, Barker P, Schumi J, Shering C, Matthews BR, Stern RA, Vellas B, Cohen S, MacSweeney E, Boada M, Sims JR. Efficacy and Safety of Lanabecestat for Treatment of Early and Mild Alzheimer Disease: The AMARANTH and DAYBREAK-ALZ Randomized Clinical Trials. JAMA Neurol. 2020 Feb 1;77(2):199-209. doi: 10.1001/jamaneurol.2019.3988.
- Cebers G, Alexander RC, Haeberlein SB, Han D, Goldwater R, Ereshefsky L, Olsson T, Ye N, Rosen L, Russell M, Maltby J, Eketjall S, Kugler AR. AZD3293: Pharmacokinetic and Pharmacodynamic Effects in Healthy Subjects and Patients with Alzheimer's Disease. J Alzheimers Dis. 2017;55(3):1039-1053. doi: 10.3233/JAD-160701.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lanabecestat | Small molecule | 20 mg | Oral |
| Subject | Lanabecestat | Small molecule | 50 mg | Oral |