Randomized, double-blind, parallel-group, placebo-controlled, fixed-dose study of Lu AE58054 in patients with mild-moderate Alzheimer’s disease treated with donepezil; Study 2 | C4C

The trial is a late stage (phase III) clinical trial in 840 people (up to 20 in London) with Alzheimer’s disease of mild to moderate severity (with scores between 12 and 22 on the MMSE memory test). People will be randomly allocated to 1 of 2 doses of a new medication (LU AE58054 10mg or 30mg) or to a dummy treatment (placebo).Neither the study participant nor the doctors will know which treatment the person is receiving (double blind design). LU AE58054 has already been studied in a smaller trial in people with Alzheimer’s disease and showed significant benefits and good safety. All participants will also be receiving their ongoing Anti-dementia treatment (donepezil), which must have been stable for 6 months before starting the trial. The main study will last for 24 weeks and the participants will have an opportunity of entering a 6 month extension study and receive LU AE58054 or a 4-week safety follow-up period without treatment of IMP.