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

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Praluent (Alirocumab)

Placebo

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Hyperlipidemias, Dyslipidemias, Lipid Metabolism Disorders

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group 1

Group 2

Arm Description

Praluent Regimen - Administration through subcutaneous injection

Placebo matching Praluent - Administration through subcutaneous injection

Outcomes

Primary Outcome Measures

Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Cognitive Domain Spatial Working Memory (SWM) Strategy Z-Score at Week 96

CANTAB SWM task assessed cognitive domain of executive function. Colored boxes were shown on a screen. A token was hidden in one of the boxes (never same box twice). Instructions were to touch boxes to search for token until number of tokens found equaled number of boxes. SWM strategy index represents number of times a search began with a different box. Z-score represents standardized measure of how far an individual deviated from study cohort average at baseline. A higher Z-score reflects better performance.

Secondary Outcome Measures

Change From Baseline in CANTAB Cognitive Domain SWM Strategy Raw Score at Week 96

CANTAB SWM task assessed cognitive domain of executive function. Colored boxes were shown on a screen. A token was hidden in one of the boxes (never same box twice). Instructions were to touch boxes to search for token until number of tokens found equaled number of boxes. SWM strategy index represents number of times a search began with a different box. Lower change from baseline raw scores reflect better SWM performance (i.e. less impairment).

Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) at Week 12, 24, 48, 72, and 96

Percent change from baseline in calculated LDL-C at Week 12, 24, 48, 72, and 96 was reported. LDL-C was measured using conventional units milligram per deciliter (mg/dL).

Percent Change From Baseline in Apolipoprotein (Apo) B at Week 12, 24, 48, 72, and 96

Percent change from baseline in Apo B at Week 12, 24, 48, 72, and 96 was reported. Apo B was measured using conventional units mg/dL.

Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24, 48, 72, and 96

Percent change from baseline in non-HDL-C at Week 12, 24, 48, 72, and 96 was reported. Non-HDL-C was measured using conventional units mg/dL.

Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12, 24, 48, 72, and 96

Percent change from baseline in calculated Total-C at Week 12, 24, 48, 72, and 96 was reported. Total-C was measured using conventional units mg/dL.

Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 12, 24, 48, 72, and 96

Percent change from baseline in Lp(a) at Week 12, 24, 48, 72, and 96 was reported. Lp(a) was measured using conventional units mg/dL.

Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24, 48, 72, and 96

Percent change from baseline in HDL-C at Week 12, 24, 48, 72, and 96 was reported. HDL-C was measured using conventional units mg/dL.

Percent Change From Baseline in Triglycerides (TG) at Week 12, 24, 48, 72, and 96

Percent change from baseline in TG at Week 12, 24, 48, 72, and 96 was reported. TG was measured using conventional units mg/dL.

Percent Change From Baseline in Apolipoprotein (Apo) A-1 at Week 12, 24, 48, 72, and 96

Percent change from baseline in Apo A-1 at Week 12, 24, 48, 72, and 96 was reported. Apo A-1 was measured using conventional units mg/dL.

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

Percentage of participants who reached LDL-C level < 70 mg/dL (1.81 mmol/L) at Week 12, 24, 48, 72, and 96 were reported.

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

Percentage of participants who reached LDL-C level < 50 mg/dL (1.29 mmol/L) at Week 12, 24, 48, 72, and 96 were reported.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs

An Adverse Event (AE) was any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. TEAE was defined as AEs that developed or worsened/became serious during on-treatment period (time from the first double-blind study treatment injection up to 70 days after the last double-blind study treatment injection). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-participant hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.

Full Information

NCT ID

NCT02957682

First Posted

October 28, 2016

Last Updated

April 14, 2021

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT02957682

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

November 2, 2016 (Actual)

Primary Completion Date

March 5, 2020 (Actual)

Study Completion Date

March 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

Keywords

Hyperlipidemias, Dyslipidemias, Lipid Metabolism Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2176 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Praluent Regimen - Administration through subcutaneous injection

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Placebo matching Praluent - Administration through subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

Praluent (Alirocumab)

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Cognitive Domain Spatial Working Memory (SWM) Strategy Z-Score at Week 96

Description

Time Frame

Week 96

Secondary Outcome Measure Information:

Title

Change From Baseline in CANTAB Cognitive Domain SWM Strategy Raw Score at Week 96

Description

CANTAB SWM task assessed cognitive domain of executive function. Colored boxes were shown on a screen. A token was hidden in one of the boxes (never same box twice). Instructions were to touch boxes to search for token until number of tokens found equaled number of boxes. SWM strategy index represents number of times a search began with a different box. Lower change from baseline raw scores reflect better SWM performance (i.e. less impairment).

Time Frame

Week 96

Title

Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) at Week 12, 24, 48, 72, and 96

Description

Percent change from baseline in calculated LDL-C at Week 12, 24, 48, 72, and 96 was reported. LDL-C was measured using conventional units milligram per deciliter (mg/dL).

Time Frame

Week 12, 24, 48, 72, and 96

Title

Percent Change From Baseline in Apolipoprotein (Apo) B at Week 12, 24, 48, 72, and 96

Description

Percent change from baseline in Apo B at Week 12, 24, 48, 72, and 96 was reported. Apo B was measured using conventional units mg/dL.

Time Frame

Week 12, 24, 48, 72, and 96

Title

Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24, 48, 72, and 96

Description

Percent change from baseline in non-HDL-C at Week 12, 24, 48, 72, and 96 was reported. Non-HDL-C was measured using conventional units mg/dL.

Time Frame

Week 12, 24, 48, 72, and 96

Title

Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12, 24, 48, 72, and 96

Description

Percent change from baseline in calculated Total-C at Week 12, 24, 48, 72, and 96 was reported. Total-C was measured using conventional units mg/dL.

Time Frame

Week 12, 24, 48, 72, and 96

Title

Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 12, 24, 48, 72, and 96

Description

Percent change from baseline in Lp(a) at Week 12, 24, 48, 72, and 96 was reported. Lp(a) was measured using conventional units mg/dL.

Time Frame

Week 12, 24, 48, 72, and 96

Title

Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24, 48, 72, and 96

Description

Percent change from baseline in HDL-C at Week 12, 24, 48, 72, and 96 was reported. HDL-C was measured using conventional units mg/dL.

Time Frame

Week 12, 24, 48, 72, and 96

Title

Percent Change From Baseline in Triglycerides (TG) at Week 12, 24, 48, 72, and 96

Description

Percent change from baseline in TG at Week 12, 24, 48, 72, and 96 was reported. TG was measured using conventional units mg/dL.

Time Frame

Week 12, 24, 48, 72, and 96

Title

Percent Change From Baseline in Apolipoprotein (Apo) A-1 at Week 12, 24, 48, 72, and 96

Description

Percent change from baseline in Apo A-1 at Week 12, 24, 48, 72, and 96 was reported. Apo A-1 was measured using conventional units mg/dL.

Time Frame

Week 12, 24, 48, 72, and 96

Title

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

Description

Percentage of participants who reached LDL-C level < 70 mg/dL (1.81 mmol/L) at Week 12, 24, 48, 72, and 96 were reported.

Time Frame

Week 12, 24, 48, 72, and 96

Title

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

Description

Percentage of participants who reached LDL-C level < 50 mg/dL (1.29 mmol/L) at Week 12, 24, 48, 72, and 96 were reported.

Time Frame

Week 12, 24, 48, 72, and 96

Title

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs

Description

Time Frame

Up to Week 96

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trial Management

Organizational Affiliation

Regeneron Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Regeneron Study Site

City

Auburn

State/Province

Alabama

ZIP/Postal Code

36830

Country

United States

Facility Name

Regeneron Study Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Regeneron Study Site

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Regeneron Study Site

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90210

Country

United States

Facility Name

Regeneron Study Site

City

Los Gatos

State/Province

California

ZIP/Postal Code

95032

Country

United States

Facility Name

Regeneron Study Site

City

North Hollywood

State/Province

California

ZIP/Postal Code

91606

Country

United States

Facility Name

Regeneron Study Site

City

Port Hueneme

State/Province

California

ZIP/Postal Code

93041

Country

United States

Facility Name

Regeneron Study Site

City

Westminster

State/Province

California

ZIP/Postal Code

92683

Country

United States

Facility Name

Regeneron Study Site 1

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80012

Country

United States

Facility Name

Regeneron Study Site 2

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80012

Country

United States

Facility Name

Regeneron Study Site

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80906

Country

United States

Facility Name

Regeneron Study Site

City

Lake Worth

State/Province

Florida

ZIP/Postal Code

33461

Country

United States

Facility Name

Regeneron Study Site

City

Lake Worth

State/Province

Florida

ZIP/Postal Code

33462

Country

United States

Facility Name

Regeneron Study Site

City

Miami Springs

State/Province

Florida

ZIP/Postal Code

33166

Country

United States

Facility Name

Regeneron Study Site

City

Covington

State/Province

Georgia

ZIP/Postal Code

30014

Country

United States

Facility Name

Regeneron Study Site

City

Champaign

State/Province

Illinois

ZIP/Postal Code

61822

Country

United States

Facility Name

Regeneron Study Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60602

Country

United States

Facility Name

Regeneron Study Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60640

Country

United States

Facility Name

Regeneron Study Site

City

Rock Island

State/Province

Illinois

ZIP/Postal Code

61201

Country

United States

Facility Name

Regeneron Study Site

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

Regeneron Study Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46237

Country

United States

Facility Name

Regeneron Study Site

City

Ames

State/Province

Iowa

ZIP/Postal Code

50010-3014

Country

United States

Facility Name

Regeneron Study Site

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Regeneron Study Site

City

Waterloo

State/Province

Iowa

ZIP/Postal Code

50702

Country

United States

Facility Name

Regeneron Study Site

City

Hutchinson

State/Province

Kansas

ZIP/Postal Code

67502

Country

United States

Facility Name

Regeneron Study Site

City

Newton

State/Province

Kansas

ZIP/Postal Code

67114

Country

United States

Facility Name

Regeneron Study Site

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66209

Country

United States

Facility Name

Regeneron Study Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40213

Country

United States

Facility Name

Regeneron Study Site

City

Bangor

State/Province

Maine

ZIP/Postal Code

04401

Country

United States

Facility Name

Regeneron Study Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21229

Country

United States

Facility Name

Regeneron Study Site

City

Oxon Hill

State/Province

Maryland

ZIP/Postal Code

20745

Country

United States

Facility Name

Regeneron Study Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55407

Country

United States

Facility Name

Regeneron Study Site

City

Olive Branch

State/Province

Mississippi

ZIP/Postal Code

38654

Country

United States

Facility Name

Regeneron Study Site

City

Washington

State/Province

Missouri

ZIP/Postal Code

63090

Country

United States

Facility Name

Regeneron Study Site

City

Buffalo

State/Province

New York

ZIP/Postal Code

14215

Country

United States

Facility Name

Regeneron Study Site

City

New Hyde Park

State/Province

New York

ZIP/Postal Code

11042

Country

United States

Facility Name

Regeneron Study Site

City

Cary

State/Province

North Carolina

ZIP/Postal Code

27518

Country

United States

Facility Name

Regeneron Study Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28209

Country

United States

Facility Name

Regeneron Study Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28277

Country

United States

Facility Name

Regeneron Study Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27401

Country

United States

Facility Name

Regeneron Study Site

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28601

Country

United States

Facility Name

Regeneron Study Site

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

Facility Name

Regeneron Study Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

Facility Name

Regeneron Study Site

City

Rocky Mount

State/Province

North Carolina

ZIP/Postal Code

27804

Country

United States

Facility Name

Regeneron Study Site

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

Regeneron Study Site

City

Statesville

State/Province

North Carolina

ZIP/Postal Code

28625

Country

United States

Facility Name

Regeneron Study Site

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Regeneron Study Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Regeneron Study Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Regeneron Study Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

Regeneron Study Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45414

Country

United States

Facility Name

Regeneron Study Site

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Regeneron Study Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Regeneron Study Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29485

Country

United States

Facility Name

Regeneron Study Site

City

Summerville

State/Province

South Carolina

ZIP/Postal Code

29615

Country

United States

Facility Name

Regeneron Study Site

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

Facility Name

Regeneron Study Site

City

Bristol

State/Province

Tennessee

ZIP/Postal Code

37620

Country

United States

Facility Name

Regeneron Study Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37760

Country

United States

Facility Name

Regeneron Study Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37912

Country

United States

Facility Name

Regeneron Study Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37938

Country

United States

Facility Name

Regeneron Study Site

City

Powell

State/Province

Tennessee

ZIP/Postal Code

37849

Country

United States

Facility Name

Regeneron Study Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Regeneron Study Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77002

Country

United States

Facility Name

Regeneron Study Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77027

Country

United States

Facility Name

Regeneron Study Site

City

Schertz

State/Province

Texas

ZIP/Postal Code

78154

Country

United States

Facility Name

Regeneron Study Site

City

Shavano Park

State/Province

Texas

ZIP/Postal Code

78231

Country

United States

Facility Name

Regeneron Study Site

City

Falls Church

State/Province

Virginia

ZIP/Postal Code

22601

Country

United States

Facility Name

Regeneron Study Site

City

Winchester

State/Province

Virginia

ZIP/Postal Code

22042

Country

United States

Facility Name

Regeneron Study Site

City

Burien

State/Province

Washington

ZIP/Postal Code

98166

Country

United States

Facility Name

Regeneron Study Site

City

Everett

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Regeneron Study Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Regeneron Study Site

City

Walla Walla

State/Province

Washington

ZIP/Postal Code

99362

Country

United States

Facility Name

Regeneron Study Site

City

Manitowoc

State/Province

Wisconsin

ZIP/Postal Code

54220

Country

United States

Facility Name

Regeneron Study Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Regeneron Study Site

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

Regeneron Study Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Regeneron Study Site

City

Sofia

ZIP/Postal Code

1309

Country

Bulgaria

Facility Name

Regeneron Study Site

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

Regeneron Study Site

City

Sofia

ZIP/Postal Code

1784

Country

Bulgaria

Facility Name

Regeneron Study Site

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

Regeneron Study Site 1

City

Varna

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

Regeneron Study Site 2

City

Varna

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

Regeneron Study Site

City

Osorno

ZIP/Postal Code

5290000

Country

Chile

Facility Name

Regeneron Study Site

City

San Miguel

ZIP/Postal Code

8910259

Country

Chile

Facility Name

Regeneron Study Site

City

Santiago

ZIP/Postal Code

7500710

Country

Chile

Facility Name

Regeneron Study Site

City

Santiago

ZIP/Postal Code

8207257

Country

Chile

Facility Name

Regeneron Study Site

City

Santiago

ZIP/Postal Code

8331143

Country

Chile

Facility Name

Regeneron Study Site

City

Santiago

Country

Chile

Facility Name

Regeneron Study Site

City

Temuco

ZIP/Postal Code

4781156

Country

Chile

Facility Name

Regeneron Study Site

City

Temuco

ZIP/Postal Code

4790869

Country

Chile

Facility Name

Regeneron Study Site

City

Viña del Mar

ZIP/Postal Code

2520997

Country

Chile

Facility Name

Regeneron Study Site

City

Paide

ZIP/Postal Code

72713

Country

Estonia

Facility Name

Regeneron Study Site

City

Tallinn

ZIP/Postal Code

10128

Country

Estonia

Facility Name

Regeneron Study Site

City

Tallinn

ZIP/Postal Code

10138

Country

Estonia

Facility Name

Regeneron Study Site 1

City

Tallinn

ZIP/Postal Code

10617

Country

Estonia

Facility Name

Regeneron Study Site 2

City

Tallinn

ZIP/Postal Code

10617

Country

Estonia

Facility Name

Regeneron Study Site

City

Tallinn

ZIP/Postal Code

11313

Country

Estonia

Facility Name

Regeneron Study Site

City

Tallinn

ZIP/Postal Code

11911

Country

Estonia

Facility Name

Regeneron Study Site

City

Tartu

ZIP/Postal Code

51014

Country

Estonia

Facility Name

Regeneron Study Site

City

Nishinomiya

State/Province

Hogo

ZIP/Postal Code

663-8501

Country

Japan

Facility Name

Regeneron Study Site

City

Kahoku-gun

State/Province

Ishikawa

ZIP/Postal Code

920-0193

Country

Japan

Facility Name

Regeneron Study Site

City

Kawasaki

State/Province

Kanagawa

ZIP/Postal Code

216-8511

Country

Japan

Facility Name

Regeneron Study Site

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

236-0004

Country

Japan

Facility Name

Regeneron Study Site

City

Uji-shi

State/Province

Kyoto

ZIP/Postal Code

611-0002

Country

Japan

Facility Name

Regeneron Study Site

City

Nakagami-gun

State/Province

Okinawa

ZIP/Postal Code

901-2393

Country

Japan

Facility Name

Regeneron Study Site

City

Iruma-gun

State/Province

Saitama

ZIP/Postal Code

350-0495

Country

Japan

Facility Name

Regeneron Study Site

City

Bunkyō-Ku

State/Province

Tokyo

ZIP/Postal Code

112-0033

Country

Japan

Facility Name

Regeneron Study Site

City

Chuo Ku

State/Province

Tokyo

ZIP/Postal Code

103-0027

Country

Japan

Facility Name

Regeneron Study Site

City

Hachiōji

State/Province

Tokyo

ZIP/Postal Code

192-0918

Country

Japan

Facility Name

Regeneron Study Site

City

Itabashi-ku

State/Province

Tokyo

ZIP/Postal Code

173-8610

Country

Japan

Facility Name

Regeneron Study Site

City

Shinagawa-Ku

State/Province

Tokyo

ZIP/Postal Code

141-0001

Country

Japan

Facility Name

Regeneron Study Site

City

Aguascalientes

ZIP/Postal Code

20230

Country

Mexico

Facility Name

Regeneron Study Site

City

Cuernavaca

ZIP/Postal Code

62250

Country

Mexico

Facility Name

Regeneron Study Site

City

Culiacán

ZIP/Postal Code

80230

Country

Mexico

Facility Name

Regeneron Study Site

City

Distrito Federal

ZIP/Postal Code

03100

Country

Mexico

Facility Name

Regeneron Study Site

City

Durango

ZIP/Postal Code

34000

Country

Mexico

Facility Name

Regeneron Study Site

City

Guadalajara

ZIP/Postal Code

44130

Country

Mexico

Facility Name

Regeneron Study Site

City

Guadalajara

ZIP/Postal Code

44160

Country

Mexico

Facility Name

Regeneron Study Site

City

Guadalajara

ZIP/Postal Code

44210

Country

Mexico

Facility Name

Regeneron Study Site

City

Merida

ZIP/Postal Code

97070

Country

Mexico

Facility Name

Regeneron Study Site

City

Mexico City

ZIP/Postal Code

03300

Country

Mexico

Facility Name

Regeneron Study Site

City

Mexico City

ZIP/Postal Code

07760

Country

Mexico

Facility Name

Regeneron Study Site

City

Mexico City

ZIP/Postal Code

11650

Country

Mexico

Facility Name

Regeneron Study Site 1

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Regeneron Study Site 2

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Regeneron Study Site

City

Monterrey

ZIP/Postal Code

64710

Country

Mexico

Facility Name

Regeneron Study Site

City

Pachuca

ZIP/Postal Code

42090

Country

Mexico

Facility Name

Regeneron Study Site

City

Querétaro

ZIP/Postal Code

76000

Country

Mexico

Facility Name

Regeneron Study Site

City

San Juan Del Río

ZIP/Postal Code

76800

Country

Mexico

Facility Name

Regeneron Study Site

City

Torreon

ZIP/Postal Code

27000

Country

Mexico

Facility Name

Regeneron Study Site

City

Ivanovo

ZIP/Postal Code

153012

Country

Russian Federation

Facility Name

Regeneron Study Site

City

Kirov

ZIP/Postal Code

610014

Country

Russian Federation

Facility Name

Regeneron Study Site

City

Moscow

ZIP/Postal Code

121309

Country

Russian Federation

Facility Name

Regeneron Study Site

City

Moscow

ZIP/Postal Code

121359

Country

Russian Federation

Facility Name

Regeneron Study Site

City

Moscow

ZIP/Postal Code

121552

Country

Russian Federation

Facility Name

Regeneron Study Site

City

Novosibirsk

ZIP/Postal Code

630008

Country

Russian Federation

Facility Name

Regeneron Study Site

City

Rostov-on-Don

ZIP/Postal Code

344068

Country

Russian Federation

Facility Name

Regeneron Study Site

City

Saint Petersburg

ZIP/Postal Code

192288

Country

Russian Federation

Facility Name

Regeneron Study Site

City

Saint Petersburg

ZIP/Postal Code

193312

Country

Russian Federation

Facility Name

Regeneron Study Site

City

Saint Petersburg

ZIP/Postal Code

195112

Country

Russian Federation

Facility Name

Regeneron Study Site

City

Saint Petersburg

ZIP/Postal Code

196601

Country

Russian Federation

Facility Name

Regeneron Study Site

City

Saint Petersburg

ZIP/Postal Code

197376

Country

Russian Federation

Facility Name

Regeneron Study Site

City

Saint Petersburg

ZIP/Postal Code

197706

Country

Russian Federation

Facility Name

Regeneron Study Site

City

Saint Petersburg

ZIP/Postal Code

198205

Country

Russian Federation

Facility Name

Regeneron Study Site

City

Saint Petersburg

ZIP/Postal Code

199106

Country

Russian Federation

Facility Name

Regeneron Study Site

City

Saratov

ZIP/Postal Code

410028

Country

Russian Federation

Facility Name

Regeneron Study Site

City

Tyumen'

ZIP/Postal Code

625000

Country

Russian Federation

Facility Name

Regeneron Study Site

City

Yaroslavl

ZIP/Postal Code

150002

Country

Russian Federation

Facility Name

Regeneron Study Site

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Regeneron Study Site 1

City

Yaroslavl

ZIP/Postal Code

150030

Country

Russian Federation

Facility Name

Regeneron Study Site 2

City

Yaroslavl

ZIP/Postal Code

150030

Country

Russian Federation

Facility Name

Regeneron Study Site

City

Kuils River

State/Province

Cape Town

ZIP/Postal Code

7580

Country

South Africa

Facility Name

Regeneron Study Site

City

Port Elizabeth

State/Province

Eastern Cape

ZIP/Postal Code

6001

Country

South Africa

Facility Name

Regeneron Study Site

City

Halfway House

State/Province

Gauteng

ZIP/Postal Code

1685

Country

South Africa

Facility Name

Regeneron Study Site

City

Pretoria West

State/Province

Gauteng

ZIP/Postal Code

183

Country

South Africa

Facility Name

Regeneron Study Site

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0002

Country

South Africa

Facility Name

Regeneron Study Site

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0184

Country

South Africa

Facility Name

Regeneron Study Site

City

Kempton Park

State/Province

Johannesburg

ZIP/Postal Code

1619

Country

South Africa

Facility Name

Regeneron Study Site

City

Soweto

State/Province

Johannesburg

ZIP/Postal Code

1818

Country

South Africa

Facility Name

Regeneron Study Site

City

Soweto

State/Province

Johannesburg

ZIP/Postal Code

2013

Country

South Africa

Facility Name

Regeneron Study Site

City

Middelburg

State/Province

Mpumalanga

ZIP/Postal Code

1050

Country

South Africa

Facility Name

Regeneron Study Site

City

Cape Town

State/Province

Western Cape

ZIP/Postal Code

7530

Country

South Africa

Facility Name

Regeneron Study Site

City

Cape Town

State/Province

Western Cape

ZIP/Postal Code

7925

Country

South Africa

Facility Name

Regeneron Study Site

City

Paarl

State/Province

Western Cape

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Regeneron Study Site

City

Somerset West

State/Province

Western Cape

ZIP/Postal Code

7130

Country

South Africa

Facility Name

Regeneron Study Site

City

Worcester

State/Province

Western Cape

ZIP/Postal Code

6850

Country

South Africa

Facility Name

Regeneron Study Site 1

City

Bloemfontein

ZIP/Postal Code

9301

Country

South Africa

Facility Name

Regeneron Study Site 2

City

Bloemfontein

ZIP/Postal Code

9301

Country

South Africa

Facility Name

Regeneron Study Site

City

Claremont

ZIP/Postal Code

7708

Country

South Africa

Facility Name

Regeneron Study Site

City

Úzhgorod

State/Province

Transcarpathian Region

ZIP/Postal Code

88000

Country

Ukraine

Facility Name

Regeneron Study Site

City

Kharkiv

ZIP/Postal Code

61002

Country

Ukraine

Facility Name

Regeneron Study Site

City

Kharkiv

ZIP/Postal Code

61039

Country

Ukraine

Facility Name

Regeneron Study Site

City

Kharkov

ZIP/Postal Code

61039

Country

Ukraine

Facility Name

Regeneron Study Site 1

City

Kiev

ZIP/Postal Code

02091

Country

Ukraine

Facility Name

Regeneron Study Site 2

City

Kiev

ZIP/Postal Code

02091

Country

Ukraine

Facility Name

Regeneron Study Site

City

Kyiv

ZIP/Postal Code

01601

Country

Ukraine

Facility Name

Regeneron Study Site 1

City

Kyiv

ZIP/Postal Code

02002

Country

Ukraine

Facility Name

Regeneron Study Site 2

City

Kyiv

ZIP/Postal Code

02002

Country

Ukraine

Facility Name

Regeneron Study Site

City

Kyiv

ZIP/Postal Code

02660

Country

Ukraine

Facility Name

Regeneron Study Site 1

City

Kyiv

ZIP/Postal Code

03037

Country

Ukraine

Facility Name

Regeneron Study Site 2

City

Kyiv

ZIP/Postal Code

03037

Country

Ukraine

Facility Name

Regeneron Study Site 1

City

Kyiv

ZIP/Postal Code

03049

Country

Ukraine

Facility Name

Regeneron Study Site 2

City

Kyiv

ZIP/Postal Code

03049

Country

Ukraine

Facility Name

Regeneron Study Site

City

Kyiv

ZIP/Postal Code

03115

Country

Ukraine

Facility Name

Regeneron Study Site

City

Kyiv

ZIP/Postal Code

04114

Country

Ukraine

Facility Name

Regeneron Study Site

City

L'viv

ZIP/Postal Code

79015

Country

Ukraine

Facility Name

Regeneron Study Site 1

City

Vinnitsa

ZIP/Postal Code

21018

Country

Ukraine

Facility Name

Regeneron Study Site 2

City

Vinnitsa

ZIP/Postal Code

21018

Country

Ukraine

Facility Name

Regeneron Study Site

City

Vinnitsa

ZIP/Postal Code

21029

Country

Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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

Hypercholesterolemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial