University of Wisconsin–Madison

Randomised, Double-blind, Parallel-group, Placebo Controlled, Fixed-dose Study of Lu AE58054 in Patients with Mild-moderate Alzheimer’s Disease Treated with Donepezil; Study 1

April 2014 to May 2017

This is an interventional, prospective, multi-national, multi-site, randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study of Lu AE58054. The target population for the study is patients with mild-moderate Alzheimer’s disease who are on a stable donepezil treatment (base treatment). The drug that is being tested in this study is called Lu AE58054. This is a new, investigational drug believed to improve cognitive function when given in addition to donepezil. Lu AE58054 is an encapsulated tablet which will be taken by mouth. This study will consist of screening, study treatment and follow-up phases. The study will include 7 visits to the clinic and 1 additional visit after the patients have stopped taking the study drug.
Patients will be randomised symmetrically at visit 2 (day 0) to one of three treatment groups: LuAE58054 60mg/day, LuAE58054 30mg/day or placebo. The total study duration per patient from baseline to the end of follow-up will be approximately 28 weeks. The study will include the following periods:
2-week screening period
24-week double-blind (Lu AE58054 30 or 60 mg/day or placebo) treatment period as add-on to donepezil 10 mg/day
4-week safety follow-up period.
Randomisation will be stratified by Mini Mental State Exam (MMSE) stratum (12-18, 19-22) based on the screening visit assessment of MMSE in order to ensure balance between the treatment groups and MMSE.

This project led by: Sanjay Asthana, MD