Safety and Tolerability of Etanercept in Alzheimer's Disease

• Research type

  Research Study

• Full title

  A phase 2, double-blind, placebo-controlled study of the safety and tolerability of etanercept in patients with Alzheimer’s disease

• IRAS ID

  26459

• Contact name

  Clive Holmes

• Sponsor organisation

  University of Southampton

• Eudract number

  2009-013400-31

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Alzheimer??s disease is a disease of the brain that destroys brain cells and causes problems with memory, thinking and behaviour. The purpose of the study is to find out whether a drug called Etanercept is safe and well-tolerated in patients with Alzheimer??s disease. 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 TNF-alpha, a protein in the body that causes inflammation. The cause of Alzheimer??s disease is unknown. However, we do know that there is inflammation in the brain of a person with Alzheimer??s disease. This inflammation in the brain causes damage to brain cells and may be responsible for some of the symptoms of Alzheimer??s disease. We have shown that inflammation in the body can result in increased inflammation in the brain. Etanercept could be a useful drug to give to patients with Alzheimer??s disease because it may indirectly reduce inflammation in the brain by reducing inflammation in the body. Reducing inflammation in the brain may help to prevent damage and death of brain cells and help with some of the symptoms of Alzheimer??s disease. In this study we will find out whether patients with Alzheimer??s disease can tolerate taking Etanercept without harmful side effects. To achieve this we will carry out a double-blind, randomized, placebo-controlled trial of Etanercept in 40 patients with mild-moderate Alzheimer's disease.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  10/H0502/8

• Date of REC Opinion

  5 Feb 2010

• REC opinion

  Further Information Favourable Opinion