EBBINGHAUS
Research type
Research Study
Full title
A Double-Blind, Placebo Controlled, Multicenter Study to Assess the Effect of Evolocumab on Cognitive Function in Patients with Clinically Evident Cardiovascular Disease and Receiving Statin Background Lipid Lowering Therapy: A Study for Subjects Enrolled in the FOURIER (Study 20110118) Trial
IRAS ID
160472
Contact name
Derek Connolly
Contact email
Sponsor organisation
Amgen Ltd
Research summary
The purpose of the EBBINGHAUS study is to learn more about memory and cognitive function (thinking abilities) in people who are receiving lipid-lowering therapy with a statin, and, in addition, are receiving the lipid-lowering investigational medication evolocumab (also known as “AMG 145”) or placebo (which looks like evolocumab but does not contain active ingredients). Patients are being invited to take part in the study because they have agreed to participate in the FOURIER trial (Amgen Protocol 20110118).
Statins have been shown to lower the blood levels of low-density lipoprotein cholesterol (LDL-cholesterol). Effects of statins on memory and cognitive function have been investigated in several studies, but the overall evidence available today is inconclusive. A number of meta analyses (studies that combine data from many individual studies) suggest that statins have either no effect or a beneficial effect on cognitive function. There are some individual reports and smaller studies that suggest a negative impact of statins.
So far, completed Amgen studies have included a total of over 6000 study participants and do not suggest any negative effects of evolocumab on memory or cognitive function. This includes longer-term studies lasting 1 year or longer. However, because this is an issue of interest to medical doctors, patients, and regulatory authorities, Amgen has designed the EBBINGHAUS study (Study 20130385) to get information specifically about cognitive function in people participating in the FOURIER trial.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
14/EM/1102
Date of REC Opinion
16 Sep 2014
REC opinion
Further Information Favourable Opinion