Study examining the effect of Etanercept on inflammation in the brain

• Research type

  Research Study

• Full title

  A double-blind, placebo-controlled study of the effect of a TNF alpha inhibitor, etanercept (Enbrel), on microglial activation in amyloid PET positive patients with Mild Cognitive Impairment due to AD-Intermediate likelihood

• IRAS ID

  181913

• Contact name

  Clive Holmes

• Contact email

  ch4@soton.ac.uk

• Sponsor organisation

  University of Southampton

• Eudract number

  2015-002145-63

• ISRCTN Number

  ISRCTN12472821

• Duration of Study in the UK

  2 years, 2 months, 30 days

• Research summary

  Title: A study examining the effect of etanercept (Enbrel) on inflammation in the brain in patients with Mild Cognitive Impairment (MCI)

  • Duration: August 2015 to December 2017
  • 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 etanercept may help to reduce inflammation in the brain. Inflammation in the brain may contribute to the onset and progression of memory problems. Etanercept is used for illnesses where parts of the body become inflamed, for example rheumatoid arthritis and psoriasis. Etanercept reduces the inflammation associated with these diseases by blocking the action of TNFalpha, a protein in the body that causes inflammation.

  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, etanercept, or a placebo, for 52 weeks, given weekly as an injection under the skin.
  • Attend 6 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/0435

• Date of REC Opinion

  26 Aug 2015

• REC opinion

  Favourable Opinion