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Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo

CompletedPhase 4

Sponsor: Regeneron Pharmaceuticals

Conditions: Hypercholesterolemia

Interventions: Praluent (Alirocumab), Placebo

Countries: United States, Bulgaria, Chile, Estonia, Japan, Mexico, Russia, South Africa

The main purpose of this study is to evaluate the effect on mental state (known as "neurocognitive function") with use of Praluent.

Eligibility overview

Sex: ALL

Age: 40 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria:

* Men and women ≥ age 40 years and ≤ age 85 years
* Patients with heterozygous familial hypercholesterolemia (heFH) or with non-familial hypercholesterolemia (non-FH) patients at high or very high cardiovascular risk
* Patients with history of coronary heart disease (CHD) not having adequate control of their hypercholesterolemia with LDL-C ≥70 mg/dL, or all other patients with LDL-C ≥100 mg/dL and be on maximally-tolerated dose of statin (unless they are statin-intolerant)
* Patients must have successfully completed the Motor Screening Task
* Patients must be willing and able to comply with clinic visits and study related procedures
* Patients must provide signed informed consent

Key Exclusion Criteria:

* Patients with known Alzheimer's disease or other dementia, schizophrenia, bipolar disorder, severe depression, cognitive impairment, or patients with a sleep disorder requiring daily pharmacological treatment
* Recent (within 3 months prior to the screening visit) myocardial infarction, unstable angina leading to hospitalization, coronary artery bypass graft surgery, percutaneous coronary intervention, uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, transient ischemic attack, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease
* Certain laboratory findings obtained during the screening visit as defined in the protocol
* Any condition or situation, including other significant mental or neurological disorders that, in the investigator's opinion, may confound the study results, or may interfere significantly with the patient's participation in the study
* Pregnant or breastfeeding women
* A positive human immunodeficiency virus (HIV) test

NOTE: Other protocol defined Inclusion/Exclusion Criteria apply

Locations (188)

Auburn, Alabama, United States
Birmingham, Alabama, United States
Mobile, Alabama, United States
Beverly Hills, California, United States
Los Gatos, California, United States
North Hollywood, California, United States
Port Hueneme, California, United States
Westminster, California, United States
Aurora, Colorado, United States
Aurora, Colorado, United States
Colorado Springs, Colorado, United States
Lake Worth, Florida, United States
Lake Worth, Florida, United States
Miami Springs, Florida, United States
Covington, Georgia, United States
Champaign, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Rock Island, Illinois, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Ames, Iowa, United States
Iowa City, Iowa, United States
Waterloo, Iowa, United States
Hutchinson, Kansas, United States
Newton, Kansas, United States
Overland Park, Kansas, United States
Louisville, Kentucky, United States
Bangor, Maine, United States
Baltimore, Maryland, United States
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