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

NCT02957682 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: R727-CL-15322016-003189-16
• Study Type: interventional
• Target: 2,176
• Locations: 9 countries
• Sites: 188

Brief Summary

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

Conditions

Hypercholesterolemia

Keywords

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 96

Secondary Outcomes (12)

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

  Week 96

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

  Week 12, 24, 48, 72, and 96

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

  Week 12, 24, 48, 72, and 96

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

  Week 12, 24, 48, 72, and 96

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

  Week 12, 24, 48, 72, and 96

Study Arms (2)

Group 1

EXPERIMENTAL

Praluent Regimen - Administration through subcutaneous injection

Drug: Praluent (Alirocumab)

Group 2

EXPERIMENTAL

Placebo matching Praluent - Administration through subcutaneous injection

Drug: Placebo

Interventions

Praluent (Alirocumab) DRUG

Group 1

Placebo DRUG

Group 2

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (188)

Regeneron Study Site

Auburn, Alabama, 36830, United States

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Birmingham, Alabama, 35209, United States

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Mobile, Alabama, 36608, United States

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Beverly Hills, California, 90210, United States

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Los Gatos, California, 95032, United States

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North Hollywood, California, 91606, United States

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Port Hueneme, California, 93041, United States

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Westminster, California, 92683, United States

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Aurora, Colorado, 80012, United States

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Regeneron Study Site 2

Aurora, Colorado, 80012, United States

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Colorado Springs, Colorado, 80906, United States

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Lake Worth, Florida, 33461, United States

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Lake Worth, Florida, 33462, United States

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Miami Springs, Florida, 33166, United States

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Covington, Georgia, 30014, United States

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Champaign, Illinois, 61822, United States

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Chicago, Illinois, 60602, United States

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Chicago, Illinois, 60640, United States

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Rock Island, Illinois, 61201, United States

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Evansville, Indiana, 47714, United States

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Indianapolis, Indiana, 46237, United States

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Ames, Iowa, 50010-3014, United States

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Iowa City, Iowa, 52242, United States

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Waterloo, Iowa, 50702, United States

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Hutchinson, Kansas, 67502, United States

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Newton, Kansas, 67114, United States

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Overland Park, Kansas, 66209, United States

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Louisville, Kentucky, 40213, United States

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Bangor, Maine, 04401, United States

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Baltimore, Maryland, 21229, United States

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Oxon Hill, Maryland, 20745, United States

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Minneapolis, Minnesota, 55407, United States

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Olive Branch, Mississippi, 38654, United States

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Washington, Missouri, 63090, United States

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Buffalo, New York, 14215, United States

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New Hyde Park, New York, 11042, United States

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Cary, North Carolina, 27518, United States

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Charlotte, North Carolina, 28209, United States

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Charlotte, North Carolina, 28277, United States

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Greensboro, North Carolina, 27401, United States

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Hickory, North Carolina, 28601, United States

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High Point, North Carolina, 27262, United States

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Raleigh, North Carolina, 27609, United States

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Rocky Mount, North Carolina, 27804, United States

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Salisbury, North Carolina, 28144, United States

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Statesville, North Carolina, 28625, United States

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Wilmington, North Carolina, 28401, United States

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Winston-Salem, North Carolina, 27103, United States

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Cincinnati, Ohio, 45219, United States

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Cleveland, Ohio, 44122, United States

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Dayton, Ohio, 45414, United States

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Duncansville, Pennsylvania, 16635, United States

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Charleston, South Carolina, 29407, United States

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Greenville, South Carolina, 29485, United States

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Summerville, South Carolina, 29615, United States

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Rapid City, South Dakota, 57701, United States

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Bristol, Tennessee, 37620, United States

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Knoxville, Tennessee, 37760, United States

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Knoxville, Tennessee, 37912, United States

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Knoxville, Tennessee, 37938, United States

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Powell, Tennessee, 37849, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77002, United States

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Houston, Texas, 77027, United States

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Schertz, Texas, 78154, United States

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Shavano Park, Texas, 78231, United States

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Falls Church, Virginia, 22601, United States

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Winchester, Virginia, 22042, United States

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Burien, Washington, 98166, United States

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Everett, Washington, 98405, United States

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Tacoma, Washington, 98405, United States

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Walla Walla, Washington, 99362, United States

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Manitowoc, Wisconsin, 54220, United States

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Pleven, 5800, Bulgaria

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Plovdiv, 4000, Bulgaria

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Plovdiv, 4002, Bulgaria

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Sofia, 1309, Bulgaria

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Sofia, 1407, Bulgaria

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Sofia, 1784, Bulgaria

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Stara Zagora, 6000, Bulgaria

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Varna, 9000, Bulgaria

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Varna, 9000, Bulgaria

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Osorno, 5290000, Chile

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San Miguel, 8910259, Chile

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Santiago, 7500710, Chile

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Santiago, 8207257, Chile

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Santiago, 8331143, Chile

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Santiago, Chile

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Temuco, 4781156, Chile

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Temuco, 4790869, Chile

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Viña del Mar, 2520997, Chile

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Paide, 72713, Estonia

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Tallinn, 10128, Estonia

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Tallinn, 10138, Estonia

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Tallinn, 10617, Estonia

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Tallinn, 10617, Estonia

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Tallinn, 11313, Estonia

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Tallinn, 11911, Estonia

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Tartu, 51014, Estonia

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Nishinomiya, Hogo, 663-8501, Japan

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Kahoku-gun, Ishikawa-ken, 920-0193, Japan

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Kawasaki, Kanagawa, 216-8511, Japan

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Yokohama, Kanagawa, 236-0004, Japan

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Uji-shi, Kyoto, 611-0002, Japan

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Nakagami-gun, Okinawa, 901-2393, Japan

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Iruma-gun, Saitama, 350-0495, Japan

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Bunkyō-Ku, Tokyo, 112-0033, Japan

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Chuo Ku, Tokyo, 103-0027, Japan

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Hachiōji, Tokyo, 192-0918, Japan

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Itabashi-ku, Tokyo, 173-8610, Japan

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Shinagawa-Ku, Tokyo, 141-0001, Japan

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Aguascalientes, 20230, Mexico

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Cuernavaca, 62250, Mexico

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Culiacán, 80230, Mexico

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Distrito Federal, 03100, Mexico

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Durango, 34000, Mexico

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Guadalajara, 44130, Mexico

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Guadalajara, 44160, Mexico

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Guadalajara, 44210, Mexico

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Mexico City, 03300, Mexico

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Mexico City, 07760, Mexico

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Mexico City, 11650, Mexico

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Mérida, 97070, Mexico

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Monterrey, 64460, Mexico

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Monterrey, 64460, Mexico

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Monterrey, 64710, Mexico

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Pachuca, 42090, Mexico

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Querétaro, 76000, Mexico

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San Juan del Río, 76800, Mexico

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Torreón, 27000, Mexico

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Ivanovo, 153012, Russia

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Kirov, 610014, Russia

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Moscow, 121309, Russia

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Moscow, 121359, Russia

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Moscow, 121552, Russia

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Novosibirsk, 630008, Russia

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Rostov-on-Don, 344068, Russia

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Saint Petersburg, 192288, Russia

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Saint Petersburg, 193312, Russia

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Saint Petersburg, 195112, Russia

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Saint Petersburg, 196601, Russia

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Saint Petersburg, 197376, Russia

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Saint Petersburg, 197706, Russia

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Saint Petersburg, 198205, Russia

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Saint Petersburg, 199106, Russia

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Saratov, 410028, Russia

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Tyumen, 625000, Russia

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Yaroslavl, 150002, Russia

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Yaroslavl, 150003, Russia

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Yaroslavl, 150030, Russia

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Yaroslavl, 150030, Russia

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Kuils River, Cape Town, 7580, South Africa

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Port Elizabeth, Eastern Cape, 6001, South Africa

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Halfway House, Gauteng, 1685, South Africa

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Pretoria, Gauteng, 0002, South Africa

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Pretoria, Gauteng, 0184, South Africa

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Pretoria West, Gauteng, 183, South Africa

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Kempton Park, Johannesburg, 1619, South Africa

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Soweto, Johannesburg, 1818, South Africa

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Soweto, Johannesburg, 2013, South Africa

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Middelburg, Mpumalanga, 1050, South Africa

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Cape Town, Western Cape, 7530, South Africa

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Cape Town, Western Cape, 7925, South Africa

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Paarl, Western Cape, 7500, South Africa

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Somerset West, Western Cape, 7130, South Africa

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Worcester, Western Cape, 6850, South Africa

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Bloemfontein, 9301, South Africa

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Bloemfontein, 9301, South Africa

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Claremont, 7708, South Africa

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Uzhhorod, Transcarpathian Region, 88000, Ukraine

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Kharkiv, 61002, Ukraine

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Kharkiv, 61039, Ukraine

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Kiev, 02091, Ukraine

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Kiev, 02091, Ukraine

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Kyiv, 01601, Ukraine

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Kyiv, 02002, Ukraine

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Regeneron Study Site 2

Kyiv, 02002, Ukraine

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Kyiv, 02660, Ukraine

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Kyiv, 03037, Ukraine

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Kyiv, 03037, Ukraine

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Kyiv, 03049, Ukraine

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Kyiv, 03049, Ukraine

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Kyiv, 03115, Ukraine

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Kyiv, 04114, Ukraine

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Lviv, 79015, Ukraine

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Vinnitsa, 21018, Ukraine

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Regeneron Study Site 2

Vinnitsa, 21018, Ukraine

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Vinnitsa, 21029, Ukraine

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MeSH Terms

Conditions

Hypercholesterolemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Interventions

alirocumab

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Clinical Trial Management
• Organization: Regeneron Pharmaceuticals, Inc

clinicaltrials@regeneron.com

844-734-6643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2016
• First Posted: November 8, 2016
• Study Start: November 2, 2016
• Primary Completion: March 5, 2020
• Study Completion: March 5, 2020
• Last Updated: May 7, 2021
• Results First Posted: May 7, 2021

Record last verified: 2021-04

Locations

UA (19); BU (9); US (73); CL (9); ZA (18); ME (19); ES (8); JP (12); RU (21)