Lu AE58054 Added to Donepezil for the Treatment for Moderate Alzheimer's Disease

NCT01019421 ↗

Phase 2 Completed 278 enrolled H. Lundbeck A/S

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to accept or reject the hypothesis that Lu AE58054 improves cognition and functional outcomes in patients with moderate Alzheimer's Disease, already in treatment with donepezil.

Timeline

Start: 2009-12
Primary completion: 2011-12
Completion: —

Outcome

Met primary endpoint

paper treatment difference of -2·16 points, 95% CI -3·62 to -0·69; p=0·0040 PMID 25297016 ↗

release “Addition of Lu AE58054 (90 mg/day) to stable donepezil treatment resulted in improved cognitive performance as measured by the primary endpoint ADAS-Cog at Week 24 (p=0.004).” otsuka.co.jp ↗

Publications

Wilkinson D, Windfeld K, Colding-Jorgensen E. Safety and efficacy of idalopirdine, a 5-HT6 receptor antagonist, in patients with moderate Alzheimer's disease (LADDER): a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2014 Nov;13(11):1092-1099. doi: 10.1016/S1474-4422(14)70198-X. Epub 2014 Oct 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Idalopirdine	Small molecule	30 mg	—