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



Status:Active, not recruiting
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:40 - 85
Updated:5/12/2018
Start Date:November 18, 2016
End Date:May 4, 2020

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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

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


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

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

- 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

The information listed above is not intended to contain all considerations relevant to a
patient's potential participation in this clinical trial and not all inclusion/exclusion
criteria are listed
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Greensboro, North Carolina 27401
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