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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02957682
• Date of registration: 28/10/2016
• Prospective Registration: Yes
• Primary sponsor: Regeneron Pharmaceuticals
• Public title: Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo
• Scientific 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
• Date of first enrolment: November 2, 2016
• Target sample size: 2176
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02957682
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Bulgaria, Chile, Colombia, Estonia, Japan, Mexico, Russian Federation, South Africa, Ukraine, United States

Contacts

• Name: Clinical Trial Management
• Affiliation: Regeneron Pharmaceuticals

Key inclusion & 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



Age minimum: 40 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hypercholesterolemia

Intervention(s)

Drug: Placebo

Drug: Praluent (Alirocumab)

Primary Outcome(s)

Change in Cambridge Neuropsychological Test Automated Battery (CANTAB) cognitive domain Spatial Working Memory (SWM) strategy score [Time Frame: Baseline to week 96]

Secondary Outcome(s)

Percent change in lipoprotein a [Lp(a)] [Time Frame: Baseline to weeks 12, 24, 48, 72, and 96]

Percent change in triglyceride (TG) [Time Frame: Baseline to weeks 12, 24, 48, 72, and 96]

Percent change in calculated low-density lipoprotein cholesterol (LDL-C) [Time Frame: Baseline to weeks 12, 24, 48, 72, and 96]

Percent change in apolipoprotein (Apo) A-1 [Time Frame: Baseline to weeks 12, 24, 48, 72, and 96]

Proportion of participants reaching LDL-C <70 mg/dL (1.81 mmol/L) [Time Frame: At weeks 12, 24, 48, 72 and 96]

Proportion of participants reaching LDL-C <50 mg/dL (1.29 mmol/L) [Time Frame: At weeks 12, 24, 48, 72, and 96]

Percent change in non-high-density lipoprotein cholesterol (non-HDL-C), [Time Frame: Baseline to weeks 12, 24, 48, 72, and 96]

Percent change in apolipoprotein (Apo) B [Time Frame: Baseline to weeks 12, 24, 48, 72, and 96]

Percent change in HDL-C [Time Frame: Baseline to weeks 12, 24, 48, 72, and 96]

Percent change in total cholesterol (Total-C) [Time Frame: Baseline to weeks 12, 24, 48, 72, and 96]

Secondary ID(s)

2016-003189-16

R727-CL-1532

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi