Overview

This trial has been completed.

Condition dyslipidemia
Treatments evolocumab (amg 145), placebo, effective statin therapy
Phase phase 3
Sponsor Amgen
Start date September 2014
End date November 2016
Trial size 1972 participants
Trial identifier NCT02207634, 20130385

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Arm
(Experimental)
Evolocumab (AMG145) Q2W or QM plus effective statin dose
evolocumab (amg 145)
Evolocumab (AMG 145)
effective statin therapy
Effective statin therapy defined as greater than or equal to atorvastatin 20 mg or an equivalent statin
(Placebo Comparator)
Placebo Q2W or QM plus effective statin dose
placebo
Placebo
effective statin therapy
Effective statin therapy defined as greater than or equal to atorvastatin 20 mg or an equivalent statin

Primary Outcomes

Measure
Mean Change from baseline over time in Spatial Working Memory (SWM) index of executive function
time frame: Mean of data collected over the study duration (up to 4 years)

Secondary Outcomes

Measure
Mean Change from baseline over time in Spatial Working Memory (SWM) between-errors score
time frame: Mean of data collected over the study duration (up to 4 years)
Mean Change from baseline over time in Paired Associated Learning (PAL) total errors adjusted.
time frame: Mean of data collected over the study duration (up to 4 years)
Mean Change from baseline over time in Reaction Time (RTI) median 5-choice reaction time
time frame: Mean of data collected over the study duration (up to 4 years)

Eligibility Criteria

Male or female participants from 40 years up to 85 years old.

Inclusion Criteria: - Randomized into Study 20110118 (FOURIER) Exclusion Criteria: - Current or known past diagnosis of dementia or mild cognitive impairment (MCI)

Additional Information

Official title A Double-Blind, Placebo Controlled, Multicenter Study to Assess the Effect of Evolocumab on Cognitive Function in Patients With Clinically Evident Cardiovascular Disease and Receiving Statin Background Lipid Lowering Therapy: A Study for Subjects Enrolled in the FOURIER (Study 20110118) Trial
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Amgen.