The Cholinergic ResponsE in Early lewy body Disease (CREED) Study

• Research type

  Research Study

• Full title

  The Cholinergic ResponsE in Early lewy body Disease (CREED) Study

• IRAS ID

  270045

• Contact name

  John-Paul Taylor

• Contact email

  john-paul.taylor@ncl.ac.uk

• Sponsor organisation

  Newcastle upon Tyne Hospitals NHS Foundation Trust

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  Lewy body dementia (LBD), which includes Parkinson’s disease dementia (PDD) and dementia with Lewy bodies (DLB), is a condition that results in problems in a brain chemical system called the cholinergic system, which contributes to symptoms like visual hallucinations, risk of falls, problems with walking and our ability to think, speak, read and understand (cognition) the world around us. LBD is the second most common cause of neurodegenerative dementia after Alzheimer’s disease (AD) with care costs of nearly double those of AD. Less than half of LBD patients respond to a cholinesterase inhibitor (CHEI), which improves cholinergic function; yet for those who do respond there is improved quality of life and lower mortality. There is currently no test that can predict treatment response to cholinesterase inhibitors.
  The aim of this study is to develop a low-cost, easy-to-acquire test to identify people with early stage LBD who will respond best to a cholinesterase inhibitor. We aim to enrol 60 participants with LBD and 16 healthy volunteers. We will utilise donepezil, a cholinesterase inhibitor which is an established treatment for Alzheimer’s dementia and may also benefit some people with LBD. Participants will be randomly assigned (like flipping a coin) to receive either donepezil or a placebo for a certain period of time (with the exception of the healthy volunteers) followed by a period when no drug would be given before switching over to the other treatment group. We will ask people to undergo a number of tests including neurocognitive and neuropsychiatry assessments, electroencephalography (EEG), magnetic resonance imaging, transcranial magnetic stimulation, gait assessment and body sensors. We will see whether we can predict any improvements in thinking abilities based on the test results.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  20/NE/0025

• Date of REC Opinion

  5 Feb 2020

• REC opinion

  Favourable Opinion