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

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ClinicalTrials.gov Identifier: NCT02957682
Recruitment Status : Active, not recruiting
First Posted : November 8, 2016
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Praluent (Alirocumab) Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : November 2, 2016
Estimated Primary Completion Date : March 5, 2020
Estimated Study Completion Date : March 5, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Alirocumab

Arm Intervention/treatment
Experimental: Group 1
Praluent Regimen - Administration through subcutaneous injection
Drug: Praluent (Alirocumab)
Experimental: Group 2
Placebo matching Praluent - Administration through subcutaneous injection
Drug: Placebo



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

Secondary Outcome Measures :
  1. Percent change in calculated low-density lipoprotein cholesterol (LDL-C) [ Time Frame: Baseline to weeks 12, 24, 48, 72, and 96 ]
  2. Percent change in apolipoprotein (Apo) B [ Time Frame: Baseline to weeks 12, 24, 48, 72, and 96 ]
  3. Percent change in non-high-density lipoprotein cholesterol (non-HDL-C), [ Time Frame: Baseline to weeks 12, 24, 48, 72, and 96 ]
  4. Percent change in total cholesterol (Total-C) [ Time Frame: Baseline to weeks 12, 24, 48, 72, and 96 ]
  5. Percent change in lipoprotein a [Lp(a)] [ Time Frame: Baseline to weeks 12, 24, 48, 72, and 96 ]
  6. Percent change in HDL-C [ Time Frame: Baseline to weeks 12, 24, 48, 72, and 96 ]
  7. Percent change in triglyceride (TG) [ Time Frame: Baseline to weeks 12, 24, 48, 72, and 96 ]
  8. Percent change in apolipoprotein (Apo) A-1 [ Time Frame: Baseline to weeks 12, 24, 48, 72, and 96 ]
  9. Proportion of participants reaching LDL-C <70 mg/dL (1.81 mmol/L) [ Time Frame: At weeks 12, 24, 48, 72 and 96 ]
  10. Proportion of participants reaching LDL-C <50 mg/dL (1.29 mmol/L) [ Time Frame: At weeks 12, 24, 48, 72, and 96 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957682


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Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02957682     History of Changes
Other Study ID Numbers: R727-CL-1532
2016-003189-16 ( EudraCT Number )
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regeneron Pharmaceuticals:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs