Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in High cardiovascUlar Risk Subjects (EBBINGHAUS)

Amgen

Status and phase: Completed; Phase 3

Conditions: Dyslipidemia

Treatments: Biological: Evolocumab; Drug: Placebo; Drug: Background Statin Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT02207634

20130385

2014-001976-75 (EudraCT Number)

Details and patient eligibility

About

This study evaluated change over time in neurocognitive testing in patients receiving statin therapy in combination with evolocumab (AMG 145), compared with patients receiving statin therapy in combination with placebo.

Full description

Participants who were enrolled in study 20110118 (FOURIER; NCT01764633) at select sites in select countries (selected based on study start-up timelines) were invited to participate in this cognitive function study, 20130385. There was no separate randomization for Study 20130385; data were analyzed according to Study 20110118 randomized treatment arm.

Enrollment: 1,974 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Randomized into Study 20110118 (FOURIER; NCT01764633)

Exclusion criteria

• Current or known past diagnosis of dementia or mild cognitive impairment (MCI)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,974 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. Participants continued with their background statin therapy during the course of the study.

Treatment:

Drug: Placebo

Drug: Background Statin Therapy

Evolocumab

Experimental group

Description:

Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study.

Treatment:

Biological: Evolocumab

Drug: Background Statin Therapy