Clinical trial NCT02957682: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Keywords: Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2016-11-08
Enrollment: 2176
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Cognitive Domain Spatial Working Memory (SWM) Strategy Z-Score at Week 96
timeFrame: Week 96
Secondary outcomes:
measure: Change From Baseline in CANTAB Cognitive Domain SWM Strategy Raw Score at Week 96
timeFrame: Week 96
measure: Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) at Week 12, 24, 48, 72, and 96
timeFrame: Week 12, 24, 48, 72, and 96
measure: Percent Change From Baseline in Apolipoprotein (Apo) B at Week 12, 24, 48, 72, and 96
timeFrame: Week 12, 24, 48, 72, and 96
measure: Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24, 48, 72, and 96
timeFrame: Week 12, 24, 48, 72, and 96
measure: Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12, 24, 48, 72, and 96
timeFrame: Week 12, 24, 48, 72, and 96
measure: Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 12, 24, 48, 72, and 96
timeFrame: Week 12, 24, 48, 72, and 96
measure: Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24, 48, 72, and 96
timeFrame: Week 12, 24, 48, 72, and 96
measure: Percent Change From Baseline in Triglycerides (TG) at Week 12, 24, 48, 72, and 96
timeFrame: Week 12, 24, 48, 72, and 96
measure: Percent Change From Baseline in Apolipoprotein (Apo) A-1 at Week 12, 24, 48, 72, and 96
timeFrame: Week 12, 24, 48, 72, and 96
measure: 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
timeFrame: Week 12, 24, 48, 72, and 96
measure: 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
timeFrame: Week 12, 24, 48, 72, and 96
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
timeFrame: Up to Week 96
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Regeneron Study Site
state: Alabama
city: Birmingham
country: United States
facility: Regeneron Study Site
state: Alabama
city: Mobile
country: United States
facility: Regeneron Study Site
state: Alabama
city: Beverly Hills
country: United States
facility: Regeneron Study Site
state: California
city: Los Gatos
country: United States
facility: Regeneron Study Site
state: California
city: North Hollywood
country: United States
facility: Regeneron Study Site
state: California
city: Port Hueneme
country: United States
facility: Regeneron Study Site
state: California
city: Westminster
country: United States
facility: Regeneron Study Site
state: California
city: Aurora
country: United States
facility: Regeneron Study Site 1
state: Colorado
city: Aurora
country: United States
facility: Regeneron Study Site 2
state: Colorado
city: Colorado Springs
country: United States
facility: Regeneron Study Site
state: Colorado
city: Lake Worth
country: United States
facility: Regeneron Study Site
state: Florida
city: Lake Worth
country: United States
facility: Regeneron Study Site
state: Florida
city: Miami Springs
country: United States
facility: Regeneron Study Site
state: Florida
city: Covington
country: United States
facility: Regeneron Study Site
state: Georgia
city: Champaign
country: United States
facility: Regeneron Study Site
state: Illinois
city: Chicago
country: United States
facility: Regeneron Study Site
state: Illinois
city: Chicago
country: United States
facility: Regeneron Study Site
state: Illinois
city: Rock Island
country: United States
facility: Regeneron Study Site
state: Illinois
city: Evansville
country: United States
facility: Regeneron Study Site
state: Indiana
city: Indianapolis
country: United States
facility: Regeneron Study Site
state: Indiana
city: Ames
country: United States
facility: Regeneron Study Site
state: Iowa
city: Iowa City
country: United States
facility: Regeneron Study Site
state: Iowa
city: Waterloo
country: United States
facility: Regeneron Study Site
state: Iowa
city: Hutchinson
country: United States
facility: Regeneron Study Site
state: Kansas
city: Newton
country: United States
facility: Regeneron Study Site
state: Kansas
city: Overland Park
country: United States
facility: Regeneron Study Site
state: Kansas
city: Louisville
country: United States
facility: Regeneron Study Site
state: Kentucky
city: Bangor
country: United States
facility: Regeneron Study Site
state: Maine
city: Baltimore
country: United States
facility: Regeneron Study Site
state: Maryland
city: Oxon Hill
country: United States
facility: Regeneron Study Site
state: Maryland
city: Minneapolis
country: United States
facility: Regeneron Study Site
state: Minnesota
city: Olive Branch
country: United States
facility: Regeneron Study Site
state: Mississippi
city: Washington
country: United States
facility: Regeneron Study Site
state: Missouri
city: Buffalo
country: United States
facility: Regeneron Study Site
state: New York
city: New Hyde Park
country: United States
facility: Regeneron Study Site
state: New York
city: Cary
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Charlotte
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Charlotte
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Greensboro
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Hickory
country: United States
facility: Regeneron Study Site
state: North Carolina
city: High Point
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Raleigh
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Rocky Mount
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Salisbury
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Statesville
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Wilmington
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Cincinnati
country: United States
facility: Regeneron Study Site
state: Ohio
city: Cleveland
country: United States
facility: Regeneron Study Site
state: Ohio
city: Dayton
country: United States
facility: Regeneron Study Site
state: Ohio
city: Duncansville
country: United States
facility: Regeneron Study Site
state: Pennsylvania
city: Charleston
country: United States
facility: Regeneron Study Site
state: South Carolina
city: Greenville
country: United States
facility: Regeneron Study Site
state: South Carolina
city: Summerville
country: United States
facility: Regeneron Study Site
state: South Carolina
city: Rapid City
country: United States
facility: Regeneron Study Site
state: South Dakota
city: Bristol
country: United States
facility: Regeneron Study Site
state: Tennessee
city: Knoxville
country: United States
facility: Regeneron Study Site
state: Tennessee
city: Knoxville
country: United States
facility: Regeneron Study Site
state: Tennessee
city: Knoxville
country: United States
facility: Regeneron Study Site
state: Tennessee
city: Powell
country: United States
facility: Regeneron Study Site
state: Tennessee
city: Dallas
country: United States
facility: Regeneron Study Site
state: Texas
city: Houston
country: United States
facility: Regeneron Study Site
state: Texas
city: Houston
country: United States
facility: Regeneron Study Site
state: Texas
city: Schertz
country: United States
facility: Regeneron Study Site
state: Texas
city: Shavano Park
country: United States
facility: Regeneron Study Site
state: Texas
city: Falls Church
country: United States
facility: Regeneron Study Site
state: Virginia
city: Winchester
country: United States
facility: Regeneron Study Site
state: Virginia
city: Burien
country: United States
facility: Regeneron Study Site
state: Washington
city: Everett
country: United States
facility: Regeneron Study Site
state: Washington
city: Tacoma
country: United States
facility: Regeneron Study Site
state: Washington
city: Walla Walla
country: United States
facility: Regeneron Study Site
state: Washington
city: Manitowoc
country: United States
facility: Regeneron Study Site
state: Wisconsin
city: Pleven
country: Bulgaria
facility: Regeneron Study Site
city: Plovdiv
country: Bulgaria
facility: Regeneron Study Site
city: Plovdiv
country: Bulgaria
facility: Regeneron Study Site
city: Sofia
country: Bulgaria
facility: Regeneron Study Site
city: Sofia
country: Bulgaria
facility: Regeneron Study Site
city: Sofia
country: Bulgaria
facility: Regeneron Study Site
city: Stara Zagora
country: Bulgaria
facility: Regeneron Study Site
city: Varna
country: Bulgaria
facility: Regeneron Study Site 1
city: Varna
country: Bulgaria
facility: Regeneron Study Site 2
city: Osorno
country: Chile
facility: Regeneron Study Site
city: San Miguel
country: Chile
facility: Regeneron Study Site
city: Santiago
country: Chile
facility: Regeneron Study Site
city: Santiago
country: Chile
facility: Regeneron Study Site
city: Santiago
country: Chile
facility: Regeneron Study Site
city: Santiago
country: Chile
facility: Regeneron Study Site
city: Temuco
country: Chile
facility: Regeneron Study Site
city: Temuco
country: Chile
facility: Regeneron Study Site
city: Viña del Mar
country: Chile
facility: Regeneron Study Site
city: Paide
country: Estonia
facility: Regeneron Study Site
city: Tallinn
country: Estonia
facility: Regeneron Study Site
city: Tallinn
country: Estonia
facility: Regeneron Study Site
city: Tallinn
country: Estonia
facility: Regeneron Study Site 1
city: Tallinn
country: Estonia
facility: Regeneron Study Site 2
city: Tallinn
country: Estonia
facility: Regeneron Study Site
city: Tallinn
country: Estonia
facility: Regeneron Study Site
city: Tartu
country: Estonia
facility: Regeneron Study Site
city: Nishinomiya
country: Japan
facility: Regeneron Study Site
state: Hogo
city: Kahoku-gun
country: Japan
facility: Regeneron Study Site
state: Ishikawa
city: Kawasaki
country: Japan
facility: Regeneron Study Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Regeneron Study Site
state: Kanagawa
city: Uji-shi
country: Japan
facility: Regeneron Study Site
state: Kyoto
city: Nakagami-gun
country: Japan
facility: Regeneron Study Site
state: Okinawa
city: Iruma-gun
country: Japan
facility: Regeneron Study Site
state: Saitama
city: Bunkyō-Ku
country: Japan
facility: Regeneron Study Site
state: Tokyo
city: Chuo Ku
country: Japan
facility: Regeneron Study Site
state: Tokyo
city: Hachiōji
country: Japan
facility: Regeneron Study Site
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Regeneron Study Site
state: Tokyo
city: Shinagawa-Ku
country: Japan
facility: Regeneron Study Site
state: Tokyo
city: Aguascalientes
country: Mexico
facility: Regeneron Study Site
city: Cuernavaca
country: Mexico
facility: Regeneron Study Site
city: Culiacán
country: Mexico
facility: Regeneron Study Site
city: Distrito Federal
country: Mexico
facility: Regeneron Study Site
city: Durango
country: Mexico
facility: Regeneron Study Site
city: Guadalajara
country: Mexico
facility: Regeneron Study Site
city: Guadalajara
country: Mexico
facility: Regeneron Study Site
city: Guadalajara
country: Mexico
facility: Regeneron Study Site
city: Merida
country: Mexico
facility: Regeneron Study Site
city: Mexico City
country: Mexico
facility: Regeneron Study Site
city: Mexico City
country: Mexico
facility: Regeneron Study Site
city: Mexico City
country: Mexico
facility: Regeneron Study Site
city: Monterrey
country: Mexico
facility: Regeneron Study Site 1
city: Monterrey
country: Mexico
facility: Regeneron Study Site 2
city: Monterrey
country: Mexico
facility: Regeneron Study Site
city: Pachuca
country: Mexico
facility: Regeneron Study Site
city: Querétaro
country: Mexico
facility: Regeneron Study Site
city: San Juan Del Río
country: Mexico
facility: Regeneron Study Site
city: Torreon
country: Mexico
facility: Regeneron Study Site
city: Ivanovo
country: Russian Federation
facility: Regeneron Study Site
city: Kirov
country: Russian Federation
facility: Regeneron Study Site
city: Moscow
country: Russian Federation
facility: Regeneron Study Site
city: Moscow
country: Russian Federation
facility: Regeneron Study Site
city: Moscow
country: Russian Federation
facility: Regeneron Study Site
city: Novosibirsk
country: Russian Federation
facility: Regeneron Study Site
city: Rostov-on-Don
country: Russian Federation
facility: Regeneron Study Site
city: Saint Petersburg
country: Russian Federation
facility: Regeneron Study Site
city: Saint Petersburg
country: Russian Federation
facility: Regeneron Study Site
city: Saint Petersburg
country: Russian Federation
facility: Regeneron Study Site
city: Saint Petersburg
country: Russian Federation
facility: Regeneron Study Site
city: Saint Petersburg
country: Russian Federation
facility: Regeneron Study Site
city: Saint Petersburg
country: Russian Federation
facility: Regeneron Study Site
city: Saint Petersburg
country: Russian Federation
facility: Regeneron Study Site
city: Saint Petersburg
country: Russian Federation
facility: Regeneron Study Site
city: Saratov
country: Russian Federation
facility: Regeneron Study Site
city: Tyumen'
country: Russian Federation
facility: Regeneron Study Site
city: Yaroslavl
country: Russian Federation
facility: Regeneron Study Site
city: Yaroslavl
country: Russian Federation
facility: Regeneron Study Site
city: Yaroslavl
country: Russian Federation
facility: Regeneron Study Site 1
city: Yaroslavl
country: Russian Federation
facility: Regeneron Study Site 2
city: Kuils River
country: South Africa
facility: Regeneron Study Site
state: Cape Town
city: Port Elizabeth
country: South Africa
facility: Regeneron Study Site
state: Eastern Cape
city: Halfway House
country: South Africa
facility: Regeneron Study Site
state: Gauteng
city: Pretoria West
country: South Africa
facility: Regeneron Study Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Regeneron Study Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Regeneron Study Site
state: Gauteng
city: Kempton Park
country: South Africa
facility: Regeneron Study Site
state: Johannesburg
city: Soweto
country: South Africa
facility: Regeneron Study Site
state: Johannesburg
city: Soweto
country: South Africa
facility: Regeneron Study Site
state: Johannesburg
city: Middelburg
country: South Africa
facility: Regeneron Study Site
state: Mpumalanga
city: Cape Town
country: South Africa
facility: Regeneron Study Site
state: Western Cape
city: Cape Town
country: South Africa
facility: Regeneron Study Site
state: Western Cape
city: Paarl
country: South Africa
facility: Regeneron Study Site
state: Western Cape
city: Somerset West
country: South Africa
facility: Regeneron Study Site
state: Western Cape
city: Worcester
country: South Africa
facility: Regeneron Study Site
state: Western Cape
city: Bloemfontein
country: South Africa
facility: Regeneron Study Site 1
city: Bloemfontein
country: South Africa
facility: Regeneron Study Site 2
city: Claremont
country: South Africa
facility: Regeneron Study Site
city: Úzhgorod
country: Ukraine
facility: Regeneron Study Site
state: Transcarpathian Region
city: Kharkiv
country: Ukraine
facility: Regeneron Study Site
city: Kharkiv
country: Ukraine
facility: Regeneron Study Site
city: Kharkov
country: Ukraine
facility: Regeneron Study Site
city: Kiev
country: Ukraine
facility: Regeneron Study Site 1
city: Kiev
country: Ukraine
facility: Regeneron Study Site 2
city: Kyiv
country: Ukraine
facility: Regeneron Study Site
city: Kyiv
country: Ukraine
facility: Regeneron Study Site 1
city: Kyiv
country: Ukraine
facility: Regeneron Study Site 2
city: Kyiv
country: Ukraine
facility: Regeneron Study Site
city: Kyiv
country: Ukraine
facility: Regeneron Study Site 1
city: Kyiv
country: Ukraine
facility: Regeneron Study Site 2
city: Kyiv
country: Ukraine
facility: Regeneron Study Site 1
city: Kyiv
country: Ukraine
facility: Regeneron Study Site 2
city: Kyiv
country: Ukraine
facility: Regeneron Study Site
city: Kyiv
country: Ukraine
facility: Regeneron Study Site
city: L'viv
country: Ukraine
facility: Regeneron Study Site
city: Vinnitsa
country: Ukraine
facility: Regeneron Study Site 1
city: Vinnitsa
country: Ukraine
facility: Regeneron Study Site 2
city: Vinnitsa
country: Ukraine
facility: Regeneron Study Site
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: