Phase 3
Completed N=1,974
Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in High cardiovascUlar Risk Subjects
Source: ClinicalTrials.gov NCT02207634 ↗Enrolled (actual)
1,974
Serious AEs
21.1%
Results posted
Jan 2018
Primary outcomePrimary: Mean Change From Baseline in Spatial Working Memory Strategy Index of Executive Function (6-8 Boxes) Z Score — 0.1206; 0.1134 Z score
◆ Published Evidence
Highly cited
483citations · ~54 / year
Cognitive Function in a Randomized Trial of Evolocumab.
Summary
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.
Linked Publications (2)
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Cognitive Function in a Randomized Trial of Evolocumab.
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PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Spatial Working Memory Strategy Index of Executive Function (6-8 Boxes) Z Score |
0.1206; 0.1134 | — |
| SECONDARY Mean Change From Baseline in Spatial Working Memory (SWM) Between-errors Z Score |
0.1024; 0.0691 | — |
| SECONDARY Mean Change From Baseline in Paired Associated Learning (PAL) Total Errors Adjusted Z Score |
0.1098; 0.0873 | — |
| SECONDARY Mean Change From Baseline in Reaction Time (RTI) Median 5-choice Reaction Time Z Score |
0.0153; -0.0575 | — |
Eligibility Criteria
Inclusion Criteria
- Randomized into Study 20110118 (FOURIER; NCT01764633)
Exclusion Criteria
- Current or known past diagnosis of dementia or mild cognitive impairment (MCI)
Data sourced from ClinicalTrials.gov (NCT02207634) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.