Phase 4
N=2,176
Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo
Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT02957682 ↗Enrolled (actual)
2,176
Serious AEs
18.7%
Results posted
May 2021
Primary outcome: Primary: Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Cognitive Domain Spatial Working Memory (SWM) Strategy Z-Score at Week 96 — -0.180; -0.200 Z-score — p=0.6055
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Praluent (Alirocumab) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Regeneron Pharmaceuticals
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Cognitive Domain Spatial Working Memory (SWM) Strategy Z-Score at Week 96 |
-0.180; -0.200 | 0.6055 |
| SECONDARY Change From Baseline in CANTAB Cognitive Domain SWM Strategy Raw Score at Week 96 |
-0.9; -1.0 | — |
| SECONDARY Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) at Week 12, 24, 48, 72, and 96 |
0.6; -49.6; 3.0; -54.2; 2.8; -51.4 | — |
| SECONDARY Percent Change From Baseline in Apolipoprotein (Apo) B at Week 12, 24, 48, 72, and 96 |
0.8; -36.7; 2.1; -40.9; 1.1; -39.0 | — |
| SECONDARY Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24, 48, 72, and 96 |
0.7; -40.4; 2.2; -44.0; 1.7; -41.1 | — |
| SECONDARY Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12, 24, 48, 72, and 96 |
-0.3; -29.6; 1.5; -31.8; 1.1; -29.6 | — |
| SECONDARY Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 12, 24, 48, 72, and 96 |
-3.3; -22.4; -0.5; -24.7; -1.4; -24.3 | — |
| SECONDARY Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24, 48, 72, and 96 |
0.6; 5.9; 3.8; 9.0; 3.8; 9.2 | — |
| SECONDARY Percent Change From Baseline in Triglycerides (TG) at Week 12, 24, 48, 72, and 96 |
0.7; -11.0; -1.8; -12.9; -1.8; -11.3 | — |
| SECONDARY Percent Change From Baseline in Apolipoprotein (Apo) A-1 at Week 12, 24, 48, 72, and 96 |
-1.3; 1.7; 2.9; 6.1; 4.7; 7.7 | — |
| SECONDARY Percentage of Participants Who Reached Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than (<) 70 mg/dL (1.81 Millimoles Per Liter [mmol/L]) at Week 12, 24, 48, 72, and 96 |
10.3; 69.4; 8.4; 74.7; 10.7; 71.4 | — |
| SECONDARY Percentage of Participants Who Reached Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than (<) 50 mg/dL (1.29 mmol/L) at Week 12, 24, 48, 72, and 96 |
1.7; 45.6; 2.0; 56.9; 2.1; 51.3 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs |
857; 866; 216; 189; 17; 13 | — |
Summary
The main purpose of this study is to evaluate the effect on mental state (known as "neurocognitive function") with use of Praluent.
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
Data sourced from ClinicalTrials.gov (NCT02957682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.