A study in which patients will be assigned, by chance, to receive either the active drug Praluent or a dummy-drug, (a placebo), without anybody knowing what that are assigned to, to determine if there is any effect on memory and reaction time, (known as Neurocognitive Function), when taking Praluent, in Patients with high cholesterol with high and very high risk for heart and blood vessel diseases

• Register: EUCTR
• Last refreshed on: 5 April 2021
• Main ID: EUCTR2016-003189-16-EE
• Date of registration: 03/11/2016
• Prospective Registration: Yes
• Primary sponsor: Regeneron Pharmaceuticals, Inc.
• Public title: A study in which patients will be assigned, by chance, to receive either the active drug Praluent or a dummy-drug, (a placebo), without anybody knowing what that are assigned to, to determine if there is any effect on memory and reaction time, (known as Neurocognitive Function), when taking Praluent, in Patients with high cholesterol with high and very high risk for heart and blood vessel diseases
• 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: 22/12/2016
• Target sample size: 2170
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003189-16
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Argentina, Bulgaria, Chile, Colombia, Estonia, Israel, Japan, Mexico, Peru, Russian Federation, Slovakia, South Africa, Ukraine, United States

Contacts

• Name: Clinical Trial Information
• Affiliation: Regeneron Pharmaceuticals, Inc.

• Name: Clinical Trial Information
• Affiliation: Regeneron Pharmaceuticals, Inc.

Key inclusion & exclusion 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 870

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).



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Heterozygous Familial Hypercholesterolemia or Non-Familial Hypercholesterolemia with High and Very High Cardiovascular Risk
MedDRA version: 20.0 Level: LLT Classification code 10054380 Term: Familial hypercholesterolemia System Organ Class: 100000004850
MedDRA version: 20.1 Level: LLT Classification code 10020604 Term: Hypercholesterolemia System Organ Class: 100000004861
MedDRA version: 20.0 Level: LLT Classification code 10068617 Term: Coronary heart disease System Organ Class: 10007541 - Cardiac disorders
MedDRA version: 20.0 Level: PT Classification code 10007649 Term: Cardiovascular disorder System Organ Class: 10007541 - Cardiac disorders
MedDRA version: 20.0 Level: LLT Classification code 10057079 Term: Heterozygous familial hypercholesterolemia System Organ Class: 100000004850

Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

Intervention(s)

Trade Name: Praluent
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Solution for injection in pre-filled pen
Route of administration of the placebo: Subcutaneous use

Trade Name: Praluent
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection in pre-filled pen
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: The primary objective of the study is to evaluate neurocognitive function
with use of Praluent after 96 weeks of treatment versus placebo

Secondary Objective: The secondary objectives are:
• To evaluate the effect of Praluent in comparison with placebo on
lipoproteins
• To evaluate the safety and tolerability of Praluent

Timepoint(s) of evaluation of this end point: Screening, Baseline, Week 24, Week 48, Week 72 and Week 96/End of Study

Primary end point(s): 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 Outcome(s)

Timepoint(s) of evaluation of this end point: From baseline to weeks 12, 24, 48, 72, and 96

Secondary end point(s): • The percent change in lipoproteins
• The proportion of patients reaching LDL-C <70 mg/dL or LDL-C <50 mg/dL

Secondary ID(s)

R727-CL-1532

Source(s) of Monetary Support

Regeneron Pharmaceuticals, Inc.

Ethics review

Status: Approved
Approval date: 22/12/2016
Contact: