COG-PBC Study
Research type
Research Study
Full title
Assessing cognitive impairment in primary biliary cirrhosis (COG-PBC)
IRAS ID
189557
Contact name
David Jones
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
31724, Application pending ISRCTN ref:
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Primary biliary cirrhosis (PBC) is an auto-immune liver disease affecting about 20,000 people in the UK. The immune system that usually protects the body from infections attacks its own cells. In PBC the bile ducts are attacked and leak so bile gets clogged in the liver (cholestasis). As well as the risks of long-term liver injury due to cholestasis, we think that cholestasis may also cause brain injury because PBC is linked with cognitive impairment (such as memory problems). Such symptoms dramatically impact on quality of life.
This research aims to find out more detail about cognitive impairment by asking people to do questionnaires and computerised tests/puzzles; this will show us things people have trouble with. We will also look at images of the brain with 2 scans and do a tracing of brain activity. We will compare results with other PBC patients who don’t have symptoms to see if there are differences.
We will look at 8 patients with moderate/severe symptoms and 8 patients with mild/no symptoms. This research will tell us if there are differences in the brain, do they happen before the symptoms start. This will be useful to find out because we can then do much bigger studies to see if by giving drugs earlier than we do now to treat PBC, it might stop symptoms and brain changes happening in the first place. It will also tell us what to measure and look for in bigger studies to come.
The study will take place at The Campus of Ageing and Vitality and the Royal Victoria Infirmary in Newcastle over 2 study visits (four weeks apart, both lasting 3-4 hours).
Visit 1 - Questionnaires, computerised tests/puzzles, magnetic resonance imaging scan (head).
Visit 2 – Positron emission tomography scan (head), electroencephalogram (trace of brain activity), computerised tests/puzzles.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
16/NE/0089
Date of REC Opinion
11 Apr 2016
REC opinion
Further Information Favourable Opinion