NorAD Version 1.0
Research type
Research Study
Full title
Randomised Clinical Trial of Noradrenergic Add-on Therapy with Extended-Release Guanfacine in Alzheimer's Disease
IRAS ID
171996
Contact name
Paresh Malhotra
Contact email
Sponsor organisation
Imperial College Healthcare NHS Trust
Eudract number
2016-002598-36
Duration of Study in the UK
2 years, 5 months, 1 days
Research summary
NorAD is a clinical trial funded by the UK National Institute of Health Research. In this trial we will assess whether a long-acting preparation of guanfacine, a drug used to treat Attention Deficit Hyperactivity Disorder in children, can improve thinking (particularly attention) in Alzheimer’s Disease (AD) when it is added to the standard NICE-approved drugs that are normally used in this condition. Guanfacine acts by increasing levels of noradrenaline, a substance in the brain which is closely linked with attention, and both noradrenaline levels and attentional performance have been shown to be reduced in Alzheimer’s Disease.
Guanfacine has been shown to boost attention in animals and healthy volunteers, and is used to treat Attention Deficit Hyperactivity Disorder in children. In previous work we have also shown that guanfacine can improve attention in stroke patients. A few studies of guanfacine treatment in AD took place around twenty years ago, with very few patients (fewer than 30 in each case) and, crucially, those studies looked at the effects of guanfacine on its own and used the standard preparation. We want to assess whether long-acting guanfacine should be used in addition to NICE-approved drugs that are currently being used in AD as part of combination therapy, since theory would suggest a greater effect when both types of drug are used together. We plan to recruit 160 patients and treat half of them with guanfacine in addition to standard medication and we will compare them with the other half who will be given placebo in addition to standard medication. We will treat all patients for 12 weeks, with assessments of thinking before guanfacine treatment, at 4 weeks and at 12 weeks. By using tests of thinking and attention, we will evaluate whether adding guanfacine to standard therapy improves thinking in Alzheimer’s Disease.
REC name
London - Westminster Research Ethics Committee
REC reference
16/LO/1258
Date of REC Opinion
12 Sep 2016
REC opinion
Further Information Favourable Opinion