Progress of Mild Alzheimer's Disease in Participants on Solanezumab Versus Placebo
Summary
To test the idea that solanezumab will slow the cognitive decline of Alzheimer's Disease (AD) as compared with placebo in participants with mild AD.
Timeline
- Start
- 2013-07
- Primary completion
- 2016-10
- Completion
- 2017-02
Outcome
Missed primary endpoint
Stopped: “Solanezumab did not meet the study's primary endpoint.”
registry analysis (superiority test); Solanezumab vs Placebo; p = 0.095; Mean Difference (Final Values) -0.80 (95% CI -1.73 to 0.14); Mixed Models Analysis NCT01900665 ↗
paper with no significant between-group difference at week 80 (difference, -0.80; 95% confidence interval, -1.73 to 0.14; P=0.10). PMID 29365294 ↗
paper As a result of the failure to reach significance with regard to the primary outcome in the prespecified hierarchical analysis PMID 29365294 ↗
release “solanezumab did not meet the primary endpoint in the EXPEDITION3 clinical trial” lilly.com ↗
release “solanezumab did not meet the primary endpoint in a Phase 3 study of people with mild dementia due to Alzheimer's disease.” lilly.com ↗
Publications
- Chandler JM, Lansdall CJ, Ye W, McDougall F, Belger M, Toth B, Mi X, Sink KM, Atkins AS. The Alzheimer's Disease Cooperative Study - Activities of Daily Living dependence score: revision and validation of an algorithm evaluating patient dependence across the spectrum of AD severity. J Prev Alzheimers Dis. 2025 Sep;12(8):100261. doi: 10.1016/j.tjpad.2025.100261. Epub 2025 Jul 1.
- Holdridge KC, Yaari R, Hoban DB, Andersen S, Sims JR. Targeting amyloid beta in Alzheimer's disease: Meta-analysis of low-dose solanezumab in Alzheimer's disease with mild dementia studies. Alzheimers Dement. 2023 Oct;19(10):4619-4628. doi: 10.1002/alz.13031. Epub 2023 Mar 22.
- Honig LS, Vellas B, Woodward M, Boada M, Bullock R, Borrie M, Hager K, Andreasen N, Scarpini E, Liu-Seifert H, Case M, Dean RA, Hake A, Sundell K, Poole Hoffmann V, Carlson C, Khanna R, Mintun M, DeMattos R, Selzler KJ, Siemers E. Trial of Solanezumab for Mild Dementia Due to Alzheimer's Disease. N Engl J Med. 2018 Jan 25;378(4):321-330. doi: 10.1056/NEJMoa1705971.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Solanezumab | Protein / enzyme biologic | 400 mg | Intravenous |