Study Complete
Sponsor ID
20130385

Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in high cardiovascUlar risk SubjectsEBBINGHAUS

Sponsor ID
20130385
Clinicaltrials.gov ID
NCT02207634
EUCTIS ID
N/A
EudraCT ID
2014-001976-75

Study Details

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.

Additional Study Details

Phase
Phase 3
Product
Evolocumab
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
1974
Additional Study Details

Protocol Summary

Primary Outcome Measures

Mean Change from baseline over time in Spatial Working Memory (SWM) index of executive function

Timeframe: Mean of data collected over the study duration (up to 4 years)

Secondary Outcome Measures

Mean Change from baseline over time in Spatial Working Memory (SWM) between-errors score

Timeframe: 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.

Timeframe: 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

Timeframe: Mean of data collected over the study duration (up to 4 years)

Study Documents

Study Synopsis
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Research Site
Daytona Beach, FL, United States, 32117
Status
Completed
Location
Research Site
Voorhees, NJ, United States, 08043
Status
Recruiting
Location
Research Site
Fort Mill, SC, United States, 29707
Status
Recruiting
Location
Research Site
Christchurch, New Zealand, 8011
Status
Recruiting
Location
Research Site
Owensboro, KY, United States, 42303
Status
Recruiting
Location
Research Site
Hollywood, FL, United States, 33021
Status
Recruiting
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