14863A Phase III study of Lu AE58054 in Alzheimer's Disease; Study 3
Research type
Research Study
Full title
Randomised, double-blind, parallel-group, placebo- controlled study of Lu AE58054 in patients with mild- moderate Alzheimer's disease treated with an acetylcholinesterase inhibitor; Study 3
IRAS ID
150835
Contact name
Craig Ritchie
Contact email
Sponsor organisation
H. Lundbeck A/S
Eudract number
2012-004765-40
Research summary
The purpose of the study is to assess whether, a research drug called Lu AE58054, given in addition to a patient's current medication (donepezil, rivastigmine or galantamine), can improve cognitive function (memory, thinking, reasoning) in patients with Alzheimer’s disease (dementia). Alzheimer´s disease is a chronic, progressive disease which gradually destroys memory and the ability to learn, reason, make judgments, communicate and carry out daily activities. In addition, patients with Alzheimer´s disease may develop symptoms such as aggression, agitation, apathy, depression, and hallucinations.
It is also a purpose of the study to get a better understanding of the drug’s safety and if is well tolerated when given in addition to donepezil, rivastigmine or galantamine in patients with Alzheimer’s disease. Donepezil, rivastigmine or galantamine all belong to the same class of treatments called acetylcholinesterase inhibitors (AChEIs). Further, it will be investigated what happens to the drug and your current medication in the body by measuring concentration of Lu AE58054 and donepezil, rivastigmine or galantamine in the blood over time.
REC name
London - Fulham Research Ethics Committee
REC reference
14/LO/1276
Date of REC Opinion
11 Sep 2014
REC opinion
Further Information Favourable Opinion