Effect of a TNF alpha inhibitor on microglial activation in MCI
Research type
Research Study
Full title
A double-blind, placebo-controlled study of the effect of a TNF alpha antibody, certolizumab pegol (Cimzia), on microglial activation in amyloid PET positive patients with Mild Cognitive Impairment due to AD-Intermediate likelihood
IRAS ID
157479
Contact name
Clive Holmes
Contact email
Eudract number
2014-003101-14
ISRCTN Number
ISRCTN43889760
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Title: A study examining the effect of Cimzia on inflammation in the brain in patients with Mild Cognitive Impairment (MCI).
• Running from February to January 2018.
• The Memory Assessment and Research Centre (MARC) in Southampton is the lead centre for the study.
• There is a second clinical site in Manchester.
• Brain scans will be done at the Wolfson Molecular Imaging Centre (WMIC) in Manchester.Who can participate?
• Women and men, age 50 to 90, with a diagnosis of MCI.
Why do this study?
The purpose of the study is to find out whether a drug called Cimzia may help to reduce inflammation in the brain. Inflammation in the brain may contribute to the onset and progression of memory problems. Cimzia is a medicine used for illnesses where parts of the body become inflamed. Cimzia has now been used for 14 years world-wide for inflammatory diseases such as rheumatoid arthritis.
The cause of Alzheimer’s disease (AD) is unknown. However, we do know that there is inflammation in the brain of a person with AD. This inflammation in the brain causes damage to brain cells and may be responsible for some of the symptoms of Alzheimer’s disease.
It is possible that the presence of inflammation in the brain may play a role in the progression of MCI to AD.
This study may improve researcher’s understanding of the causes of MCI and AD and may lead to the development of medicines to treat MCI and AD.
Participants will undergo
• Initial health check and memory testing.
• Attend the WMIC for brain scans.
• If eligible for the study, they will receive the study drug, Cimzia, or a placebo, for 52 weeks, given fortnightly as an injection under the skin.
• Attend 7 more study visits.
• Attend WMIC at end of study for repeat brain scans.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
15/SC/0015
Date of REC Opinion
13 Feb 2015
REC opinion
Further Information Favourable Opinion