14861B Extension study of Lu AE58054 in Alzheimer's disease
Research type
Research Study
Full title
An open-label extension study to evaluate the long-term safety and tolerability of Lu AE58054 as adjunctive treatment to donepezil in patients with mild-moderate Alzheimer's disease
IRAS ID
165287
Contact name
Louisa Vass
Contact email
Sponsor organisation
H. Lundbeck A/S
Eudract number
2013-000001-23
Duration of Study in the UK
1 years, 10 months, 30 days
Research summary
This is an interventional, multi-national, multi-site, open-label extension study in patients with mild to moderate Alzheimer's Disease (AD) who completed the 24-week "lead-in" double-blind, placebo controlled clinical studies 14861A and 14862A (from now on these studies will be referred to as “lead-in study” throughout IRAS form) . Note that that the14861A lead-in study is not being conducted in the UK. However, the 14862A lead-in study is being conducted in the UK.
In this extension study, all participants will receive 60 mg/day of study drug, Lu AE58054, in combination with their standard donepezil hydrochloride (donepezil) medication (10 mg/day). The dose of Lu AE58054 can be decreased to 30 mg/day if 60 mg/day is not well tolerated in the opinion of the investigator.
The purpose of this extension study is to evaluate the safety and tolerability of Lu AE58054 over a longer period of time when given with donepezil.
The total study duration for the participants will be 32 weeks which includes a 28 week treatment period and a 4 week follow-up period.
As with the lead-in study, participants will be required to have a caregiver who will also consent to take part in this extension study. Without a caregiver, the participant will not be able to take part in the study.
REC name
Scotland A: Adults with Incapacity only
REC reference
15/SS/0032
Date of REC Opinion
3 Jun 2015
REC opinion
Further Information Favourable Opinion