Trial · NCT02207634
Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in High cardiovascUlar Risk Subjects
NCT02207634, Phase 3, Completed, Amgen; results first posted 2018-01-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in High cardiovascUlar Risk Subjects. Trials, record NCT02207634. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02207634
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in High cardiovascUlar Risk Subjects
- NCT number
- NCT02207634
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,974 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Dyslipidemia
- Interventions
- Evolocumab, Placebo, Background Statin Therapy
- First posted
- 2014-08-04
- Last updated
- 2018-01-16
- Other registries' IDs
- eudract:2014-001976-75
- Results first posted
- 2018-01-16
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Spatial Working Memory Strategy Index of Executive Function (6-8 Boxes) Z Score | Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months). | Assessments were performed with the Cambridge Neuropsychological Test Automated Battery (CANTAB), a language-independent battery of computerized tests that is used to assess cognitive function. The Spatial Working Memory (SWM) test assesses the cognitive domain of executive function (high-level thinking and decision making). Patients search for colored tokens hidden inside boxes on the screen by touching them. The critical instruction is that once a token has been found inside a box, there will never be a token hidden inside that box again, so patients must not return to a box where a token has been found. The SWM strategy index of executive function represented the number of times a subject began a search with a different box. The Z score represents the standardized measure of how far an individual subject deviates from the study cohort average at baseline. A higher Z score reflects better performance. The mean change from baseline averaged across all the visits is reported. |
| Secondary | Mean Change From Baseline in Spatial Working Memory (SWM) Between-errors Z Score | Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months). | Assessments were performed with the CANTAB, a language-independent battery of computerized tests that is used to assess cognitive function. The Spatial Working Memory (SWM) between-errors test assesses the cognitive domain of working memory (holding material in mind while that material is being actively processed). Patients search for colored tokens hidden inside boxes on the screen by touching them. The critical instruction is that once a token has been found inside a box, there will never be a token hidden inside that box again, so patients must not return to a box where a token has been found. The SWM between-errors score is the number of times that a patient revisited a box in which a token had previously been found. The Z score represents the standardized measure of how far an individual participant deviates from the study cohort average at baseline. A higher Z score reflects better performance. The mean change from baseline averaged across all the visits is reported. |
| Secondary | Mean Change From Baseline in Paired Associated Learning (PAL) Total Errors Adjusted Z Score | Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months). | The CANTAB PAL test assesses visuospatial episodic memory (storing/retrieving information by associating an event with a time and place). Boxes on the screen opened up one at a time to reveal a number of patterns. Participants were asked to remember the location of each pattern. After all the boxes had been opened, each pattern was then shown in the center of the screen in a randomized order, and the patient should touch the box where they think each pattern was hidden. The PAL total errors adjusted comprised the number of errors committed by a patient plus an adjustment for the estimated number of errors the patient would have made on any stages that were not reached. Z score represents the standardized measure of how far an individual patient deviates from the study cohort average at baseline. A higher Z score indicated better performance. The mean change from baseline averaged across all the visits is reported. |
| Secondary | Mean Change From Baseline in Reaction Time (RTI) Median 5-choice Reaction Time Z Score | Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months). | Assessments were performed with the CANTAB, a language-independent battery of computerized tests that is used to assess cognitive function. The Reaction Time (RTI) test assessed the cognitive domain of psychomotor speed (detecting and responding to a stimulus). Participants held down a button until a spot appeared in 1 of 5 circles on the screen. As soon as possible after the spot flashed up, the patient lifted their finger from the button and touched the circle in which the spot appeared. The RTI median 5-choice reaction time was the median duration between the onset of the stimulus and the release of the button. Z score represents the standardized measure of how far an individual participant deviates from the study cohort average at baseline. A higher Z score reflects better performance. The mean change from baseline averaged across all the visits is reported. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Spatial Working Memory Strategy Index of Executive Function (6-8 Boxes) Z Score | Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months). | All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.~Cognitive function assessments after an on-study stroke event were excluded from the analysis. | Z score | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Spatial Working Memory (SWM) Between-errors Z Score | Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months). | All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.~Cognitive function assessments after an on-study stroke event were excluded from the analysis. | Z score | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Paired Associated Learning (PAL) Total Errors Adjusted Z Score | Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months). | All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.~Cognitive function assessments after an on-study stroke event were excluded from the analysis. | Z score | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Reaction Time (RTI) Median 5-choice Reaction Time Z Score | Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months). | All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.~Cognitive function assessments after an on-study stroke event were excluded from the analysis. | Z score | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Spatial Working Memory Strategy Index of Executive Function (6-8 Boxes) Z Score | Placebo | 0.1206 | 95% Confidence Interval 0.0535 to 0.1877 | Z score | |
| Mean Change From Baseline in Spatial Working Memory Strategy Index of Executive Function (6-8 Boxes) Z Score | Evolocumab | 0.1134 | 95% Confidence Interval 0.0449 to 0.1820 | Z score | |
| Mean Change From Baseline in Spatial Working Memory (SWM) Between-errors Z Score | Placebo | 0.1024 | 95% Confidence Interval 0.0373 to 0.1675 | Z score | |
| Mean Change From Baseline in Spatial Working Memory (SWM) Between-errors Z Score | Evolocumab | 0.0691 | 95% Confidence Interval 0.0026 to 0.1355 | Z score | |
| Mean Change From Baseline in Paired Associated Learning (PAL) Total Errors Adjusted Z Score | Placebo | 0.1098 | 95% Confidence Interval 0.0511 to 0.1686 | Z score | |
| Mean Change From Baseline in Paired Associated Learning (PAL) Total Errors Adjusted Z Score | Evolocumab | 0.0873 | 95% Confidence Interval 0.0273 to 0.1472 | Z score | |
| Mean Change From Baseline in Reaction Time (RTI) Median 5-choice Reaction Time Z Score | Placebo | 0.0153 | 95% Confidence Interval -0.0529 to 0.0834 | Z score | |
| Mean Change From Baseline in Reaction Time (RTI) Median 5-choice Reaction Time Z Score | Evolocumab | -0.0575 | 95% Confidence Interval -0.1270 to 0.0121 | Z score |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 990 | |
| Overall Study | STARTED | Evolocumab | 984 | |
| Overall Study | Received Treatment | Placebo | 990 | |
| Overall Study | Received Treatment | Evolocumab | 983 | |
| Overall Study | COMPLETED | Placebo | 968 | |
| Overall Study | COMPLETED | Evolocumab | 953 | |
| Overall Study | NOT COMPLETED | Placebo | 22 | |
| Overall Study | NOT COMPLETED | Evolocumab | 31 |
Source ClinicalTrials.gov
Adverse events678
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Placebo | 74 | 990 | |
| other | Nasopharyngitis | Infections and infestations | Evolocumab | 101 | 983 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 63 | 990 | |
| other | Upper respiratory tract infection | Infections and infestations | Evolocumab | 53 | 983 | |
| other | Diabetes mellitus | Metabolism and nutrition disorders | Placebo | 59 | 990 | |
| other | Diabetes mellitus | Metabolism and nutrition disorders | Evolocumab | 45 | 983 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 36 | 990 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Evolocumab | 58 | 983 | |
| other | Hypertension | Vascular disorders | Placebo | 66 | 990 | |
| other | Hypertension | Vascular disorders | Evolocumab | 61 | 983 |
1 to 10 of 678Source ClinicalTrials.gov
See all 678 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Evolocumab | ||
| Total, other adverse events | Placebo | 257 | 990 |
| Total, other adverse events | Evolocumab | 272 | 983 |
| Total, serious adverse events | Placebo | 204 | 990 |
| Total, serious adverse events | Evolocumab | 212 | 983 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Evolocumab vs Placebo: serious adverse events |
Source Trial comparisons
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Choice Reaction Time | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02207634
GET https://conductscience.org/api/trials/v1/NCT02207634/events?page=2