Donepezil in Early Dementia Associated with Parkinson's Disease (V 1.0
Research type
Research Study
Full title
Multicentre UK Study of the Acetylcholinesterase Inhibitor Donepezil in Early Dementia Associated with Parkinson's Disease (MUSTARDD-PD)
IRAS ID
23965
Contact name
David J Burn
Sponsor organisation
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Eudract number
2009-015170-35
ISRCTN Number
30151023
Clinicaltrials.gov Identifier
Research summary
Every day in the UK, between 30 and 40 people will be told they have Parkinson's disease (PD). Of these, nearly four-fifths will go on to develop dementia in association with their PD. We wish to test the effectiveness of a drug called donepezil in people with dementia associated with Parkinson's disease (PDD) in a study called MUSTARDD-PD. Donepezil is one of a class of drugs known as cholinesterase inhibitors. It is important to learn whether donepezil in PDD produces benefits that are meaningful to patients and their families, whilst also being good value for money. In MUSTARDD-PD, the participant will have only mild symptoms of dementia and so will be able to give informed consent themselves. We are using a study design called a randomised double blind controlled design. This is a rigorous way of checking whether a particular drug may have an effect. Two large groups will receive either donepezil or an identical tablet, called a placebo, which contains no active drug. Each participant will be put into a group by chance (randomly). This is a 'double blind trial', so neither the participant nor the research team will know which treatment group the participant's in. Participants will take either the donepezil or placebo for up to two years. The results will then be compared to see if one treatment is better than the other. The trial will be carried out at 22 sites in the UK. Study subjects will be living in the community and recruited mainly through hospital out-patient clinics. We will assess measures of cognition (items like memory and attention), psychiatric disturbances (for example, visual hallucinations) and how the person is able to perform activities of daily living to determine whether this treatment works. We will measure changes in patient and carer quality of life between those people allocated to take donepezil and those taking placebo. We will also look at the services people use, their costs and the time spent by family members providing unpaid care so that we can perform a health economic evaluation.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
10/H0906/11
Date of REC Opinion
24 Mar 2010
REC opinion
Further Information Favourable Opinion