R727-CL-1532 Ph4 Praluent,Neurocognitive Funct.,Hypercholesterolaemia
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Praluent on Neurocognitive Function in Patients with Heterozygous Familial Hypercholesterolemia or with Non-Familial Hypercholesterolemia at High and Very High Cardiovascular Risk
IRAS ID
214950
Contact name
Diana A. Gorog
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2016-003189-16
Clinicaltrials.gov Identifier
105574, IND number
Duration of Study in the UK
3 years, 4 months, 23 days
Research summary
Praluent was approved in the EU for use in adults as a treatment for primary hypercholesterolaemia (Heterozygous Familial Hypercholesterolaemia (heFH) and Non-Familial Hypercholesterolemia (non-FH)) or mixed dyslipidaemia (elevated levels of lipids in the blood), as an addition to
-diet in combination with a statin
-or statin with other lipid lowering therapies in patients unable to reach low density lipoprotein cholesterol (LDL-C) goals, an unhealthy type of fat, with the maximum tolerated dose of a statin,
-or alone or in combination with other lipid-lowering therapies.There have been rare post-marketing reports of impairment to cognition (thinking, understanding, processing information) associated with statin use. Statins are a group of medicines that can help lower the level of LDL-C in the blood. However, limited information is available on the effect that very low circulating LDL will have on cognition. Praluent works in a similar way to a statin, by lowering LDL-C in the blood. The main aim of this study is therefore to assess the cognitive function in heFH patients and non-FH patients, at high or very high cardiovascular risk, receiving Praluent compared with placebo after 96 weeks of treatment.
The 96-week treatment duration is considered sufficient to evaluate the effect of Praluent on cognitive function.The study consists of the following 2 periods, a screening period of up to 3 weeks, and a treatment period of 96 weeks. Patients will be randomised to receive either placebo or Praluent every 2 weeks. Patients’ cognitive function will be assessed every 6 months.
At week 8 patients who are receiving Praluent and whose LDL-C levels has increased will have the dose of study drug increased at the week 12 visit until the end of the study.
This will be a multinational study. The planned number of sites is up to 300. Approximately 2170 patients are planned.
REC name
London - London Bridge Research Ethics Committee
REC reference
16/LO/2052
Date of REC Opinion
7 Dec 2016
REC opinion
Unfavourable Opinion