PCNorAD
Research type
Research Study
Full title
Physiological Correlates of Noradrenergic Add-on Therapy in Alzheimer’s Disease
IRAS ID
232750
Contact name
Paresh Malhotra
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
17HH4208, JRCO and insurance reference ; 171996, NorAD IRAS Project ID ; 16/LO/1258, NorAD REC reference
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
The proposed study (PCNorAD) is to examine a number of markers of brain function in the context of the NIHR-funded NorAD Clinical Trial. This randomised double-blind, placebo-controlled Trial is being carried out to investigate whether combination therapy with Extended-Release Guanfacine (GXR) and standard Cholinesterase Inhibitors (ChEIs) is superior to treatment with ChEIs alone. Noradrenergic systems are known to be affected early in Alzheimer’s Disease (AD) and noradrenaline is particularly important for attentional processes, which are also impaired early in AD. The participants will either be recruited from the NorAD trial or as controls unrelated to NorAD. The study team will be aware which patients are recruited from the NorAD trial but will remain blinded as to whether they are receiving guanfacine or placebo, thus preventing any effect on the outcome on the main NorAD trial. Equal numbers of patients taking active drug and placebo will be recruited without any unblinding taking place.
Although the NorAD study does include some neuropsychological measures of cognition, there are a number of critical questions that are not within the remit of the trial. AD is increasingly recognized as having a more heterogeneous cognitive profile than previously thought, and the current proposal aims to find out how to identify groups of patients that might respond to combination treatment, and which biomarkers might mirror clinical improvement observed during the trial. The studies build on recent findings in the fields of cognitive neuroscience, dementia research and neuropharmacology, and the framework of the NorAD trial provides a unique opportunity for carrying out this clinical research. We will use non-invasive methods to examine brain activity in patients on active drug and patients taking placebo. These will include scanning, pupil measurements and will help us to find out whether changes in thinking are reliably related to specific alterations in brain activity.REC name
London - Central Research Ethics Committee
REC reference
18/LO/0249
Date of REC Opinion
3 Jul 2018
REC opinion
Further Information Favourable Opinion