Trial · NCT02957682
Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo
NCT02957682, Phase 4, Completed, Regeneron Pharmaceuticals; results first posted 2021-05-07
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo. Trials, record NCT02957682. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02957682
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo
- NCT number
- NCT02957682
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 2,176 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Hypercholesterolemia
- Interventions
- Praluent (Alirocumab), Placebo
- First posted
- 2016-11-08
- Last updated
- 2021-05-07
- Other registries' IDs
- eudract:2016-003189-16
- Results first posted
- 2021-05-07
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Cognitive Domain Spatial Working Memory (SWM) Strategy Z-Score at Week 96 | Week 96 | CANTAB SWM task assessed cognitive domain of executive function. Colored boxes were shown on a screen. A token was hidden in one of the boxes (never same box twice). Instructions were to touch boxes to search for token until number of tokens found equaled number of boxes. SWM strategy index represents number of times a search began with a different box. Z-score represents standardized measure of how far an individual deviated from study cohort average at baseline. A higher Z-score reflects better performance. |
| Secondary | Change From Baseline in CANTAB Cognitive Domain SWM Strategy Raw Score at Week 96 | Week 96 | CANTAB SWM task assessed cognitive domain of executive function. Colored boxes were shown on a screen. A token was hidden in one of the boxes (never same box twice). Instructions were to touch boxes to search for token until number of tokens found equaled number of boxes. SWM strategy index represents number of times a search began with a different box. Lower change from baseline raw scores reflect better SWM performance (i.e. less impairment). |
| Secondary | Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) at Week 12, 24, 48, 72, and 96 | Week 12, 24, 48, 72, and 96 | Percent change from baseline in calculated LDL-C at Week 12, 24, 48, 72, and 96 was reported. LDL-C was measured using conventional units milligram per deciliter (mg/dL). |
| Secondary | Percent Change From Baseline in Apolipoprotein (Apo) B at Week 12, 24, 48, 72, and 96 | Week 12, 24, 48, 72, and 96 | Percent change from baseline in Apo B at Week 12, 24, 48, 72, and 96 was reported. Apo B was measured using conventional units mg/dL. |
| Secondary | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24, 48, 72, and 96 | Week 12, 24, 48, 72, and 96 | Percent change from baseline in non-HDL-C at Week 12, 24, 48, 72, and 96 was reported. Non-HDL-C was measured using conventional units mg/dL. |
| Secondary | Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12, 24, 48, 72, and 96 | Week 12, 24, 48, 72, and 96 | Percent change from baseline in calculated Total-C at Week 12, 24, 48, 72, and 96 was reported. Total-C was measured using conventional units mg/dL. |
| Secondary | Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 12, 24, 48, 72, and 96 | Week 12, 24, 48, 72, and 96 | Percent change from baseline in Lp(a) at Week 12, 24, 48, 72, and 96 was reported. Lp(a) was measured using conventional units mg/dL. |
| Secondary | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24, 48, 72, and 96 | Week 12, 24, 48, 72, and 96 | Percent change from baseline in HDL-C at Week 12, 24, 48, 72, and 96 was reported. HDL-C was measured using conventional units mg/dL. |
| Secondary | Percent Change From Baseline in Triglycerides (TG) at Week 12, 24, 48, 72, and 96 | Week 12, 24, 48, 72, and 96 | Percent change from baseline in TG at Week 12, 24, 48, 72, and 96 was reported. TG was measured using conventional units mg/dL. |
| Secondary | Percent Change From Baseline in Apolipoprotein (Apo) A-1 at Week 12, 24, 48, 72, and 96 | Week 12, 24, 48, 72, and 96 | Percent change from baseline in Apo A-1 at Week 12, 24, 48, 72, and 96 was reported. Apo A-1 was measured using conventional units mg/dL. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Cognitive Domain Spatial Working Memory (SWM) Strategy Z-Score at Week 96 | Week 96 | Primary safety population included participants from the safety population who had an assessment of the SWM strategy score at baseline, and at least 1 score measured during the treatment-emergent adverse event (TEAE) period. The TEAE period is defined as the first double-blind treatment dose to last dose of double-blind treatment + 70 days (10 weeks). Participants were analyzed according to the treatment actually received. | Z-score | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in CANTAB Cognitive Domain SWM Strategy Raw Score at Week 96 | Week 96 | Primary safety population included participants from the safety population who had an assessment of the SWM strategy score at baseline, and at least 1 score measured during the treatment-emergent adverse event (TEAE) period. The TEAE period is defined as the first double-blind treatment dose to last dose of double-blind treatment + 70 days (10 weeks). Participants were analyzed according to the treatment actually received. | Units on a Scale | MEAN |
| SECONDARY | Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) at Week 12, 24, 48, 72, and 96 | Week 12, 24, 48, 72, and 96 | Intent-to-treat (ITT) population included all participants with availability of at least 1 measurement value for calculated LDL-C before first dose of study drug (i.e. baseline) and within 1 of the analysis windows during the main efficacy period; the main efficacy period is defined as the time from the first double-blind study treatment injection up to the upper limit of the week 96 analysis window. ITT population analyzed according to treatment group allocated by randomization (as-randomized). | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Apolipoprotein (Apo) B at Week 12, 24, 48, 72, and 96 | Week 12, 24, 48, 72, and 96 | ITT population included all participants with availability of at least 1 measurement value for calculated LDL-C before first dose of study drug (i.e. baseline) and within 1 of the analysis windows during the main efficacy period; the main efficacy period is defined as the time from the first double-blind study treatment injection up to the upper limit of the week 96 analysis window. ITT population analyzed according to treatment group allocated by randomization (as-randomized). | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24, 48, 72, and 96 | Week 12, 24, 48, 72, and 96 | ITT population included all participants with availability of at least 1 measurement value for calculated LDL-C before first dose of study drug (i.e. baseline) and within 1 of the analysis windows during the main efficacy period; the main efficacy period is defined as the time from the first double-blind study treatment injection up to the upper limit of the week 96 analysis window. ITT population analyzed according to treatment group allocated by randomization (as-randomized). | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12, 24, 48, 72, and 96 | Week 12, 24, 48, 72, and 96 | ITT population included all participants with availability of at least 1 measurement value for calculated LDL-C before first dose of study drug (i.e. baseline) and within 1 of the analysis windows during the main efficacy period; the main efficacy period is defined as the time from the first double-blind study treatment injection up to the upper limit of the week 96 analysis window. ITT population analyzed according to treatment group allocated by randomization (as-randomized). | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 12, 24, 48, 72, and 96 | Week 12, 24, 48, 72, and 96 | ITT Population was used. The two-step multiple imputation procedure is used to address missing values in the randomized population. In the first step, the monotone missing pattern is induced in the multiply-imputed data. In the second step, the missing data at subsequent visits are imputed using the regression method for continuous variables. | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24, 48, 72, and 96 | Week 12, 24, 48, 72, and 96 | ITT population included all participants with availability of at least 1 measurement value for calculated LDL-C before first dose of study drug (i.e. baseline) and within 1 of the analysis windows during the main efficacy period; the main efficacy period is defined as the time from the first double-blind study treatment injection up to the upper limit of the week 96 analysis window. ITT population analyzed according to treatment group allocated by randomization (as-randomized). | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Triglycerides (TG) at Week 12, 24, 48, 72, and 96 | Week 12, 24, 48, 72, and 96 | ITT population was used. The two-step multiple imputation procedure is used to address missing values in the randomized population. In the first step, the monotone missing pattern is induced in the multiply-imputed data. In the second step, the missing data at subsequent visits are imputed using the regression method for continuous variables | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Apolipoprotein (Apo) A-1 at Week 12, 24, 48, 72, and 96 | Week 12, 24, 48, 72, and 96 | ITT population included all participants with availability of at least 1 measurement value for calculated LDL-C before first dose of study drug (i.e. baseline) and within 1 of the analysis windows during the main efficacy period; the main efficacy period is defined as the time from the first double-blind study treatment injection up to the upper limit of the week 96 analysis window. ITT population analyzed according to treatment group allocated by randomization (as-randomized). | Percent Change | LEAST_SQUARES_MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group112
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Cognitive Domain Spatial Working Memory (SWM) Strategy Z-Score at Week 96 | Placebo | -0.180 | Standard Error 0.027 | Z-score | |
| Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Cognitive Domain Spatial Working Memory (SWM) Strategy Z-Score at Week 96 | Alirocumab 75 Q2W/Up150 Q2W | -0.200 | Standard Error 0.027 | Z-score | |
| Change From Baseline in CANTAB Cognitive Domain SWM Strategy Raw Score at Week 96 | Placebo | -0.9 | Standard Deviation 4.49 | Units on a Scale | |
| Change From Baseline in CANTAB Cognitive Domain SWM Strategy Raw Score at Week 96 | Alirocumab 75 Q2W/Up150 Q2W | -1.0 | Standard Deviation 4.31 | Units on a Scale | |
| Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) at Week 12, 24, 48, 72, and 96 | Placebo | Percent change at Week 12 | 0.6 | Standard Error 1.0 | Percent Change |
| Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) at Week 12, 24, 48, 72, and 96 | Alirocumab 75 Q2W/Up150 Q2W | Percent change at Week 12 | -49.6 | Standard Error 0.9 | Percent Change |
| Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) at Week 12, 24, 48, 72, and 96 | Placebo | Percent change at Week 24 | 3.0 | Standard Error 1.0 | Percent Change |
| Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) at Week 12, 24, 48, 72, and 96 | Alirocumab 75 Q2W/Up150 Q2W | Percent change at Week 24 | -54.2 | Standard Error 1.0 | Percent Change |
| Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) at Week 12, 24, 48, 72, and 96 | Placebo | Percent change at Week 48 | 2.8 | Standard Error 1.1 | Percent Change |
| Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) at Week 12, 24, 48, 72, and 96 | Alirocumab 75 Q2W/Up150 Q2W | Percent change at Week 48 | -51.4 | Standard Error 1.1 | Percent Change |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 1,088 | |
| Overall Study | STARTED | Alirocumab 75 Q2W/Up150 Q2W | 1,088 | |
| Overall Study | Randomized and Treated | Placebo | 1,085 | |
| Overall Study | Randomized and Treated | Alirocumab 75 Q2W/Up150 Q2W | 1,086 | |
| Overall Study | COMPLETED | Placebo | 890 | |
| Overall Study | COMPLETED | Alirocumab 75 Q2W/Up150 Q2W | 919 | |
| Overall Study | NOT COMPLETED | Placebo | 198 | |
| Overall Study | NOT COMPLETED | Alirocumab 75 Q2W/Up150 Q2W | 169 |
Source ClinicalTrials.gov
Adverse events556
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 | Bronchitis | Infections and infestations | Placebo | 65 | 1,084 | 72 |
| other | Bronchitis | Infections and infestations | Alirocumab 75 Q2W/Up150 Q2W | 60 | 1,087 | 78 |
| other | Influenza | Infections and infestations | Placebo | 69 | 1,084 | 77 |
| other | Influenza | Infections and infestations | Alirocumab 75 Q2W/Up150 Q2W | 63 | 1,087 | 69 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 89 | 1,084 | 117 |
| other | Nasopharyngitis | Infections and infestations | Alirocumab 75 Q2W/Up150 Q2W | 82 | 1,087 | 98 |
| other | Urinary tract infection | Infections and infestations | Placebo | 46 | 1,084 | 65 |
| other | Urinary tract infection | Infections and infestations | Alirocumab 75 Q2W/Up150 Q2W | 61 | 1,087 | 78 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 71 | 1,084 | 82 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Alirocumab 75 Q2W/Up150 Q2W | 60 | 1,087 | 66 |
1 to 10 of 556Source ClinicalTrials.gov
See all 556 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 24 | 1,084 |
| Total, all-cause mortality | Alirocumab 75 Q2W/Up150 Q2W | 17 | 1,087 |
| Total, other adverse events | Placebo | 387 | 1,084 |
| Total, other adverse events | Alirocumab 75 Q2W/Up150 Q2W | 366 | 1,087 |
| Total, serious adverse events | Placebo | 216 | 1,084 |
| Total, serious adverse events | Alirocumab 75 Q2W/Up150 Q2W | 189 | 1,087 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Alirocumab 75 Q2W/Up150 Q2W vs Placebo: deaths from any cause | Trial comparisons |
| Alirocumab 75 Q2W/Up150 Q2W vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
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/NCT02957682
GET https://conductscience.org/api/trials/v1/NCT02957682/results?page=2