High cholesterol levels in the blood Hypercholesterolaemia
Conditions
Interventions
Study Drug:
Praluent
75 mg /subcutaneous (SC)/Q2W for 94 weeks
OR
Placebo matching Praluent
SC/Q2W for 94 weeks
Sponsors
Regeneron
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Men and women * age 40 and * age 85 2. Patients with heFH or non-FH patients at high or very high cardiovascular risk 3. Patients with history of 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 a maximally-tolerated dose of statin (unless they are statin-intolerant) for at least 28 days prior to the screening visit. 4. Patients must have successfully completed the Motor Screening Task
Exclusion criteria
Exclusion criteria: 1. Patients with known Alzheimer*s disease or other dementia, schizophrenia, bipolar disorder, severe depression (*11 score of the Geriatric Depression Scale short form [GDS-S; Appendix 8]), cognitive impairment (<26 score of the Montreal Cognitive Assessment [MoCA]; Appendix 9]), or patients with a sleep disorder requiring daily pharmacological treatment 2. Patients >85 year old 3. Patient with a hemorrhagic stroke within last 5 years 4. History of a 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, or carotid revascularization within 3 months prior to the screening visit, or endovascular procedure or surgical intervention for peripheral vascular disease within 3 months prior to the screening visit. 5. eGFR <30 mL/min/1.73 m2 according to 4-variable Modification of Diet in Renal Disease Study equation (calculated by a central lab). 6. Signs and symptoms of hypothyroidism 7. History of a 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, or carotid revascularization within 3 months prior to the screening visit, or endovascular procedure or surgical intervention for peripheral vascular disease within 3 months prior to the screening visit 8. Pregnant or breastfeeding women 9. A positive human immunodeficiency virus (HIV) test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the change in Cambridge Neuropsychological Test Automated Battery (CANTAB) cognitive domain Spatial Working Memory (SWM) strategy score from baseline to week 96. | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory neurocognitive outcome measures to further assess neurocognitive function in the CANTAB domains are provided below for each patient: * Paired Associates Learning (PAL) at week 96 defined as both a PAL z-score change from baseline and PAL raw score change from baseline, following the definitions and rules provided for the primary neurocognitive endpoint * Reaction Time (RTI) at week 96 defined as both a RTI z-score change from baseline and RTI raw score change from baseline, following the definitions and rules provided for the primary neurocognitive endpoint * SWM between-errors score at week 96 defined as both a SWM between-errors z score change from baseline and SWM between-errors raw score change from baseline, following the definitions and rules provided for the primary neurocognitive endpoint * Global Composite score at week 96 change from baseline is defined as (the average of the following 4 measures at week 96: SWM strategy z-score, PAL z score, RTI z-score, and the SWM between-errors z-score) minus the average of the same 4 z-score measures at baseline Secondary efficacy endpoints are: * The percent change in calculated LDL-C, apolipoprotein (Apo) B, non high density lipoprotein (HDL) cholesterol (HDL-C), and total cholesterol (Total-C) from baseline to weeks 12, 24, 48, 72, and 96 * The percent change in lipoprotein a [Lp(a)], HDL-C, triglyceride (TG), and Apo A-1 from baseline to weeks 12, 24, 48, 72, and 96 * The proportion of patients reaching LDL-C | — |
Countries
Netherlands
Outcome results
None listed