Phase 3
N=1,974
Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in High cardiovascUlar Risk Subjects
Dyslipidemia
Bottom Line
View on ClinicalTrials.gov: NCT02207634 ↗Enrolled (actual)
1,974
Serious AEs
21.1%
Results posted
Jan 2018
Primary outcome: Primary: Mean Change From Baseline in Spatial Working Memory Strategy Index of Executive Function (6-8 Boxes) Z Score — 0.1206; 0.1134 Z score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Evolocumab (Biological); Placebo (Drug); Background Statin Therapy (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Nov 2016
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 | — |
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.
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). 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.