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

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia

Treatments: Drug: Placebo; Drug: Praluent (Alirocumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02957682

R727-CL-1532

2016-003189-16 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 2,176 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,176 participants in 2 patient groups

Group 1

Experimental group

Description:

Praluent Regimen - Administration through subcutaneous injection

Treatment:

Drug: Praluent (Alirocumab)

Group 2

Experimental group

Description:

Placebo matching Praluent - Administration through subcutaneous injection

Treatment:

Drug: Placebo