HypercholesterolemiaPhase 4NCT02957682

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

A Phase 4 study testing Praluent (Alirocumab) in people with Hypercholesterolemia, run by Regeneron Pharmaceuticals at 188 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 40 to 85 years
Conditions the study is for: Hypercholesterolemia
What is being tested?: Praluent (Alirocumab)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2,176 participants
Where: 188 sitesin 9 countries
Study dates: 2 Nov 2016to 5 Mar 2020
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

188 sites in 9 countries.

Country

City, postcode or hospital

188 sites in 9 countries

United States73 sites

Regeneron Study Site
Ames, Iowa, 50010-3014
Regeneron Study Site
Auburn, Alabama, 36830
Regeneron Study Site 1
Aurora, Colorado, 80012
Regeneron Study Site 2
Aurora, Colorado, 80012
Regeneron Study Site
Baltimore, Maryland, 21229
Regeneron Study Site
Bangor, Maine, 04401
Regeneron Study Site
Beverly Hills, California, 90210
Regeneron Study Site
Birmingham, Alabama, 35209
Regeneron Study Site
Bristol, Tennessee, 37620
Regeneron Study Site
Buffalo, New York, 14215
Regeneron Study Site
Burien, Washington, 98166
Regeneron Study Site
Cary, North Carolina, 27518
Regeneron Study Site
Champaign, Illinois, 61822
Regeneron Study Site
Charleston, South Carolina, 29407
Regeneron Study Site
Charlotte, North Carolina, 28209
Regeneron Study Site
Charlotte, North Carolina, 28277
Regeneron Study Site
Chicago, Illinois, 60602
Regeneron Study Site
Chicago, Illinois, 60640
Regeneron Study Site
Cincinnati, Ohio, 45219
Regeneron Study Site
Cleveland, Ohio, 44122
Regeneron Study Site
Colorado Springs, Colorado, 80906
Regeneron Study Site
Covington, Georgia, 30014
Regeneron Study Site
Dallas, Texas, 75231
Regeneron Study Site
Dayton, Ohio, 45414
Regeneron Study Site
Duncansville, Pennsylvania, 16635
Regeneron Study Site
Evansville, Indiana, 47714
Regeneron Study Site
Everett, Washington, 98405
Regeneron Study Site
Falls Church, Virginia, 22601
Regeneron Study Site
Greensboro, North Carolina, 27401
Regeneron Study Site
Greenville, South Carolina, 29485
Regeneron Study Site
Hickory, North Carolina, 28601
Regeneron Study Site
High Point, North Carolina, 27262
Regeneron Study Site
Houston, Texas, 77002
Regeneron Study Site
Houston, Texas, 77027
Regeneron Study Site
Hutchinson, Kansas, 67502
Regeneron Study Site
Indianapolis, Indiana, 46237
Regeneron Study Site
Iowa City, Iowa, 52242
Regeneron Study Site
Knoxville, Tennessee, 37760
Regeneron Study Site
Knoxville, Tennessee, 37912
Regeneron Study Site
Knoxville, Tennessee, 37938
Regeneron Study Site
Lake Worth, Florida, 33461
Regeneron Study Site
Lake Worth, Florida, 33462
Regeneron Study Site
Los Gatos, California, 95032
Regeneron Study Site
Louisville, Kentucky, 40213
Regeneron Study Site
Manitowoc, Wisconsin, 54220
Regeneron Study Site
Miami Springs, Florida, 33166
Regeneron Study Site
Minneapolis, Minnesota, 55407
Regeneron Study Site
Mobile, Alabama, 36608
Regeneron Study Site
New Hyde Park, New York, 11042
Regeneron Study Site
Newton, Kansas, 67114
Regeneron Study Site
North Hollywood, California, 91606
Regeneron Study Site
Olive Branch, Mississippi, 38654
Regeneron Study Site
Overland Park, Kansas, 66209
Regeneron Study Site
Oxon Hill, Maryland, 20745
Regeneron Study Site
Port Hueneme, California, 93041
Regeneron Study Site
Powell, Tennessee, 37849
Regeneron Study Site
Raleigh, North Carolina, 27609
Regeneron Study Site
Rapid City, South Dakota, 57701
Regeneron Study Site
Rock Island, Illinois, 61201
Regeneron Study Site
Rocky Mount, North Carolina, 27804
Regeneron Study Site
Salisbury, North Carolina, 28144
Regeneron Study Site
Schertz, Texas, 78154
Regeneron Study Site
Shavano Park, Texas, 78231
Regeneron Study Site
Statesville, North Carolina, 28625
Regeneron Study Site
Summerville, South Carolina, 29615
Regeneron Study Site
Tacoma, Washington, 98405
Regeneron Study Site
Walla Walla, Washington, 99362
Regeneron Study Site
Washington, Missouri, 63090
Regeneron Study Site
Waterloo, Iowa, 50702
Regeneron Study Site
Westminster, California, 92683
Regeneron Study Site
Wilmington, North Carolina, 28401
Regeneron Study Site
Winchester, Virginia, 22042
Regeneron Study Site
Winston-Salem, North Carolina, 27103

Other trials in United States

Russia21 sites

Regeneron Study Site
Ivanovo, 153012
Regeneron Study Site
Kirov, 610014
Regeneron Study Site
Moscow, 121309
Regeneron Study Site
Moscow, 121359
Regeneron Study Site
Moscow, 121552
Regeneron Study Site
Novosibirsk, 630008
Regeneron Study Site
Rostov-on-Don, 344068
Regeneron Study Site
Saint Petersburg, 192288
Regeneron Study Site
Saint Petersburg, 193312
Regeneron Study Site
Saint Petersburg, 195112
Regeneron Study Site
Saint Petersburg, 196601
Regeneron Study Site
Saint Petersburg, 197376
Regeneron Study Site
Saint Petersburg, 197706
Regeneron Study Site
Saint Petersburg, 198205
Regeneron Study Site
Saint Petersburg, 199106
Regeneron Study Site
Saratov, 410028
Regeneron Study Site
Tyumen, 625000
Regeneron Study Site
Yaroslavl, 150002
Regeneron Study Site
Yaroslavl, 150003
Regeneron Study Site 1
Yaroslavl, 150030
Regeneron Study Site 2
Yaroslavl, 150030

Other trials in Russia

Mexico19 sites

Regeneron Study Site
Aguascalientes, 20230
Regeneron Study Site
Cuernavaca, 62250
Regeneron Study Site
Culiacán, 80230
Regeneron Study Site
Distrito Federal, 03100
Regeneron Study Site
Durango, 34000
Regeneron Study Site
Guadalajara, 44130
Regeneron Study Site
Guadalajara, 44160
Regeneron Study Site
Guadalajara, 44210
Regeneron Study Site
Mérida, 97070
Regeneron Study Site
Mexico City, 03300
Regeneron Study Site
Mexico City, 07760
Regeneron Study Site
Mexico City, 11650
Regeneron Study Site 1
Monterrey, 64460
Regeneron Study Site 2
Monterrey, 64460
Regeneron Study Site
Monterrey, 64710
Regeneron Study Site
Pachuca, 42090
Regeneron Study Site
Querétaro, 76000
Regeneron Study Site
San Juan del Río, 76800
Regeneron Study Site
Torreón, 27000

Other trials in Mexico

Ukraine19 sites

Regeneron Study Site
Kharkiv, 61002
Regeneron Study Site
Kharkiv, 61039
Regeneron Study Site 1
Kiev, 02091
Regeneron Study Site 2
Kiev, 02091
Regeneron Study Site
Kyiv, 01601
Regeneron Study Site 1
Kyiv, 02002
Regeneron Study Site 2
Kyiv, 02002
Regeneron Study Site
Kyiv, 02660
Regeneron Study Site 1
Kyiv, 03037
Regeneron Study Site 2
Kyiv, 03037
Regeneron Study Site 1
Kyiv, 03049
Regeneron Study Site 2
Kyiv, 03049
Regeneron Study Site
Kyiv, 03115
Regeneron Study Site
Kyiv, 04114
Regeneron Study Site
Lviv, 79015
Regeneron Study Site
Uzhhorod, Transcarpathian Region, 88000
Regeneron Study Site 1
Vinnitsa, 21018
Regeneron Study Site 2
Vinnitsa, 21018
Regeneron Study Site
Vinnitsa, 21029

Other trials in Ukraine

South Africa18 sites

Regeneron Study Site 1
Bloemfontein, 9301
Regeneron Study Site 2
Bloemfontein, 9301
Regeneron Study Site
Cape Town, Western Cape, 7530
Regeneron Study Site
Cape Town, Western Cape, 7925
Regeneron Study Site
Claremont, 7708
Regeneron Study Site
Halfway House, Gauteng, 1685
Regeneron Study Site
Kempton Park, Johannesburg, 1619
Regeneron Study Site
Kuils River, Cape Town, 7580
Regeneron Study Site
Middelburg, Mpumalanga, 1050
Regeneron Study Site
Paarl, Western Cape, 7500
Regeneron Study Site
Port Elizabeth, Eastern Cape, 6001
Regeneron Study Site
Pretoria, Gauteng, 0002
Regeneron Study Site
Pretoria, Gauteng, 0184
Regeneron Study Site
Pretoria West, Gauteng, 183
Regeneron Study Site
Somerset West, Western Cape, 7130
Regeneron Study Site
Soweto, Johannesburg, 1818
Regeneron Study Site
Soweto, Johannesburg, 2013
Regeneron Study Site
Worcester, Western Cape, 6850

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Japan12 sites

Regeneron Study Site
Bunkyō-Ku, Tokyo, 112-0033
Regeneron Study Site
Chuo Ku, Tokyo, 103-0027
Regeneron Study Site
Hachiōji, Tokyo, 192-0918
Regeneron Study Site
Iruma-gun, Saitama, 350-0495
Regeneron Study Site
Kahoku-gun, Ishikawa-ken, 920-0193
Regeneron Study Site
Kawasaki, Kanagawa, 216-8511
Regeneron Study Site
Nakagami-gun, Okinawa, 901-2393
Regeneron Study Site
Nishinomiya, Hogo, 663-8501
Regeneron Study Site
Shinagawa-Ku, Tokyo, 141-0001
Regeneron Study Site
tabashi City, Tokyo, 173-8610
Regeneron Study Site
Uji-shi, Kyoto, 611-0002
Regeneron Study Site
Yokohama, Kanagawa, 236-0004

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Bulgaria9 sites

Regeneron Study Site
Pleven, 5800
Regeneron Study Site
Plovdiv, 4000
Regeneron Study Site
Plovdiv, 4002
Regeneron Study Site
Sofia, 1309
Regeneron Study Site
Sofia, 1407
Regeneron Study Site
Sofia, 1784
Regeneron Study Site
Stara Zagora, 6000
Regeneron Study Site 1
Varna, 9000
Regeneron Study Site 2
Varna, 9000

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Chile9 sites

Regeneron Study Site
Osorno, 5290000
Regeneron Study Site
San Miguel, 8910259
Regeneron Study Site
Santiago, 7500710
Regeneron Study Site
Santiago, 8207257
Regeneron Study Site
Santiago, 8331143
Regeneron Study Site
Santiago
Regeneron Study Site
Temuco, 4781156
Regeneron Study Site
Temuco, 4790869
Regeneron Study Site
Viña del Mar, 2520997

Other trials in Chile

Estonia8 sites

Regeneron Study Site
Paide, 72713
Regeneron Study Site
Tallinn, 10128
Regeneron Study Site
Tallinn, 10138
Regeneron Study Site 1
Tallinn, 10617
Regeneron Study Site 2
Tallinn, 10617
Regeneron Study Site
Tallinn, 11313
Regeneron Study Site
Tallinn, 11911
Regeneron Study Site
Tartu, 51014

Other trials in Estonia

About this study

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

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

Conditions: Hypercholesterolemia
Being tested: Praluent (Alirocumab), Placebo
Keywords: Hyperlipidemias, Dyslipidemias, Lipid Metabolism Disorders
Medical subject headings: Hypercholesterolemia, Hyperlipidemias, Dyslipidemias, Lipid Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Praluent (Alirocumab)Drug
PlaceboDrug

Study groups in NCT02957682
Study group	Role	What they receive
Group 1	Experimental	Praluent Regimen - Administration through subcutaneous injection Receives: Drug: Praluent (Alirocumab)
Group 2	Experimental	Placebo matching Praluent - Administration through subcutaneous injection Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Week 96

Secondary outcomes (12)

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).
Measured: Week 96
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).
Measured: Week 12, 24, 48, 72, and 96
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.
Measured: 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
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.
Measured: Week 12, 24, 48, 72, and 96
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.
Measured: Week 12, 24, 48, 72, and 96
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.
Measured: Week 12, 24, 48, 72, and 96
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.
Measured: Week 12, 24, 48, 72, and 96
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.
Measured: Week 12, 24, 48, 72, and 96
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.
Measured: Week 12, 24, 48, 72, and 96
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.
Measured: Week 12, 24, 48, 72, and 96
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.
Measured: Week 12, 24, 48, 72, and 96
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.
Measured: Up to Week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Nov 20165 Mar 2020

First posted8 Nov 2016 (estimated)
Study start2 Nov 2016
Primary completion5 Mar 2020
Study completion5 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2,176 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02957682
Sponsor's protocol ID: R727-CL-1532
Other IDs: 2016-003189-16, 2016
Status last verified: Apr 2021
First submitted: 28 Oct 2016
Last updated: 7 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02957682
Acronym / sponsor ID: R727-CL-1532
Conditions: Hypercholesterolemia
Keywords: Hyperlipidemias, Dyslipidemias, Lipid Metabolism Disorders
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,176 participants (actual)
Lead sponsor: Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: Sanofi
Study start: 2 Nov 2016 (actual)
Primary completion: 5 Mar 2020 (actual)
Study completion: 5 Mar 2020 (actual)
First posted: 8 Nov 2016 (estimated)
Results: Posted 7 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group 1	Experimental	Drug: Praluent (Alirocumab)Praluent Regimen - Administration through subcutaneous injection
Group 2	Experimental	Drug: PlaceboPlacebo matching Praluent - Administration through subcutaneous injection

Who may qualify

Ages: 40 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Praluent (Alirocumab)	Drug	Group 1
Placebo	Drug	Group 2

Primary outcome

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

12 secondary outcomes

Change From Baseline in CANTAB Cognitive Domain SWM Strategy Raw Score at Week 96
Time frame: Week 96
Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) at Week 12, 24, 48, 72, and 96
Time frame: Week 12, 24, 48, 72, and 96
Percent Change From Baseline in Apolipoprotein (Apo) B at Week 12, 24, 48, 72, and 96
Time frame: 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
Time frame: Week 12, 24, 48, 72, and 96
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12, 24, 48, 72, and 96
Time frame: Week 12, 24, 48, 72, and 96
Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 12, 24, 48, 72, and 96
Time frame: Week 12, 24, 48, 72, and 96
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24, 48, 72, and 96
Time frame: Week 12, 24, 48, 72, and 96
Percent Change From Baseline in Triglycerides (TG) at Week 12, 24, 48, 72, and 96
Time frame: Week 12, 24, 48, 72, and 96
Percent Change From Baseline in Apolipoprotein (Apo) A-1 at Week 12, 24, 48, 72, and 96
Time frame: Week 12, 24, 48, 72, and 96
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
Time frame: Week 12, 24, 48, 72, and 96
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
Time frame: Week 12, 24, 48, 72, and 96
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: Up to Week 96

Results and safety

Results posted to the registry on 7 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	1,088	890
Alirocumab 75 Q2W/Up150 Q2W	1,088	919

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

Time frame: Week 96. Least squares mean (Standard Error). Unit: Z-score

Measure	Placebo n = 1035	Alirocumab 75 Q2W/Up150 Q2W n = 1051
Value	-0.180 (0.027)	-0.200 (0.027)

Placebo vs Alirocumab 75 Q2W/Up150 Q2W: Least Square (LS) Mean Difference: -0.020 (95% CI -0.094 to 0.055), p = 0.6055, Mixed-effect Model Repeated Measures

Population analysed: Primary safety population included participants from the safety population who had an assessment of the SWM strategy score at baseline, and at least 1 score measured during the treatment-emergent adverse event (TEAE) period. The TEAE period is defined as the first double-blind treatment dose to last dose of double-blind treatment + 70 days (10 weeks). Participants were analyzed according to the treatment actually received.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 96) regardless of seriousness or relationship to investigational product (IP).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	216 of 1,084 (19.9%)	387 of 1,084 (35.7%)	24 of 1,084
Alirocumab 75 Q2W/Up150 Q2W	189 of 1,087 (17.4%)	366 of 1,087 (33.7%)	17 of 1,087

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Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trial Management study director

Regeneron Pharmaceuticals

188 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Praluent (Alirocumab) in people with Hypercholesterolemia, run by Regeneron Pharmaceuticals at 188 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 188 sites in United States, Russia, Mexico, Ukraine, South Africa and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Cognitive Domain Spatial Working Memory (SWM) Strategy Z-Score at Week 96 (time frame: Week 96). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02957682.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.