14862A Phase III trial of Lu AE58054 in Alzheimer's Disease
Research type
Research Study
Full title
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 2
IRAS ID
149117
Contact name
Fraser Inglis
Contact email
Sponsor organisation
Lundbeck LLC
Eudract number
2012-004764-22
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
14/EM/0123,
Research summary
The purpose of the study is to assess whether a research drug called Lu AE58054, given in addition to donepezil, can improve the 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.
A further aim of this study is to get a better understanding of the drug’s safety and to see if it is well tolerated when given in addition to donepezil in patients with Alzheimer’s disease. Investigations will also be carried out to see what happens to Lu AE58054 and donepezil levels in the body by measuring the concentration of both drugs in the blood, over time.
REC name
Scotland A REC
REC reference
14/SS/1018
Date of REC Opinion
10 Sep 2014
REC opinion
Further Information Favourable Opinion