Trial · NCT01428453
A Phase 2a Study to Evaluate the Effect of Rilapladib (SB-659032) in Alzheimer's Disease
NCT01428453, Phase 2, Completed, GlaxoSmithKline; results first posted 2018-09-24
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Phase 2a Study to Evaluate the Effect of Rilapladib (SB-659032) in Alzheimer's Disease. Trials, record NCT01428453. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01428453
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2a Study to Evaluate the Effect of Rilapladib (SB-659032) in Alzheimer's Disease
- NCT number
- NCT01428453
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 124 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Alzheimer's Disease
- Interventions
- 250mg rilapladib, placebo
- First posted
- 2011-09-05
- Last updated
- 2018-09-24
- Results first posted
- 2018-09-24
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline (Day 0) in Cerebral Spinal Fluid (CSF) Amyloid Beta Peptide (Abeta) 42 and Abeta40 at Week 24 | Baseline (Day 0) and Week 24 | CSF Abeta biomarkers (Abeta42, Abeta40) were assessed at Baseline visit (Day 0) and Week 24 (Day 168). Change from Baseline in CSF Abeta42 and Abeta40 are summarized. Baseline and Week 24 study visits were taken place at approximately the same time of day in the morning (preferably between 08:00 and 12:00) to improve the reliability of CSF. Baseline value was defined as the latest Day 0 value. Change from Baseline was calculated as post-dose (Week 24) visit value minus Baseline value. The data is presented in for adjusted mean and standard error of adjusted mean. |
| Primary | Change From Baseline (Day 0) in CSF Abeta42/ Abeta40 Ratio at Week 24 | Baseline (Day 0) and Week 24 | CSF Abeta biomarkers (Abeta42, Abeta40) were assessed at Baseline visit (Day 0) and Week 24 (Day 168). Change from Baseline in CSF Abeta42/Abeta40 ratio is summarized. Baseline and Week 24 study visits were taken place at approximately the same time of day in the morning (preferably between 08:00 and 12:00) to improve the reliability of CSF. Baseline value was defined as the latest Day 0 value. Change from Baseline was calculated as post-dose (Week 24) visit value minus Baseline value. The data is presented in for adjusted mean and standard error of adjusted mean. |
| Primary | Change From Baseline (Day 0) in CSF Tau and Phosphorylated Tau (P-tau) Measures at Week 24 | Baseline (Day 0) and Week 24 | CSF tau and P-tau were assessed at Baseline visit (Day 0) and Week 24 (Day 168). Change from Baseline in CSF tau and P-tau was summarized. Baseline and Week 24 study visits were taken place at approximately the same time of day in the morning (preferably between 08:00 and 12:00) to improve the reliability of CSF. Baseline value was defined as the latest Day 0 value. Change from Baseline was calculated as post-dose (Week 24) visit value minus Baseline value. The data is presented in for adjusted mean and standard error of adjusted mean. |
| Primary | Change From Baseline (Day 0) in the Computerized Test Battery for Cognition (CogState) Battery Working Memory/Executive Function (WM/EF) Composite Score at Week 24 | Baseline (Day 0) and Week 24 | The WM/EF composite score was comprised of 5 functional tests including 1) Controlled oral word association which measured language fluency, planning and working memory, 2) Category naming: It measures semantic fluency, planning and working memory, 3) One-back: This is a measure of working memory. 4) Trail B: This is a measure of motor speed, visual scanning, and visual-motor integration. This test required attention and cognitive flexibility. 5) Go No-Go task: This test evaluate accuracy and reaction time for each response. The composite score calculated by standardizing the total score: sum of all responses obtained from these 5 functional test by using the formula (Total score of ITT population at baseline - Total score at Week 24) /standard deviation of mean total mean score at baseline. The observed composite score ranged from minimum -1.474 and maximum 1.596. Lower score means better cognitive status. Change from Baseline was calculated as post-dose visit minus Baseline value. |
| Secondary | Change From Baseline (Day 0) in CSF Albumin Quotients at Week 24 | Baseline (Day 0) and Week 24 | CSF albumin quotient was assessed at Baseline visit (Day 0) and Week 24 (Day 168). Change from Baseline in albumin quotient is summarized. Baseline and Week 24 study visits were taken place at approximately the same time of day in the morning (preferably between 08:00 and 12:00) to improve the reliability of CSF. Baseline value was defined as the latest Day 0 value. Change from Baseline was calculated as post-dose (Week 24) visit value minus Baseline value. The data is presented in for adjusted mean and standard error of adjusted mean. |
| Secondary | Change From Baseline (Day 0) in Plasma Levels of Abeta42 and Abeta40 at Week 24 | Baseline (Day 0) and Week 24 | Plasma Abeta biomarkers (Abeta42, Abeta40) were assessed at Baseline visit (Day 0) and Week 24 (Day 168). Change from Baseline in plasma Abeta42 and Abeta40 are summarized. Baseline value was defined as the latest Day 0 value. Change from Baseline was calculated as post-dose (Week 24) visit value minus Baseline value. The data is presented in for adjusted mean and standard error of adjusted mean. |
| Secondary | Change From Baseline (Day 0) in Plasma Levels of Abeta42/Abeta40 Ratio at Week 24 | Baseline (Day 0) and Week 24 | Plasma Abeta biomarkers (Abeta42, Abeta40) were assessed at Baseline visit (Day 0) and Week 24 (Day 168). Change from Baseline in plasma Abeta42/Abeta40 ratio is summarized. Baseline value was defined as the latest Day 0 value. Change from Baseline was calculated as post-dose (Week 24) visit value minus Baseline value. The data is presented in for adjusted mean and standard error of adjusted mean. |
| Secondary | Percentage Inhibition in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity at Week 24 | Baseline (Day 0) and Week 24 | Plasma Lp-PLA2 was assessed at Baseline visit (Day 0) and Week 24 (Day 168). Percentage inhibition in plasma Lp-PLA2 activity ratio is summarized. Percentage inhibition was calculated by dividing change from Baseline in plasma LpPLA2 by Baseline LpPLA2 multiplied by -100. Baseline value was defined as the latest Day 0 value. Change from Baseline was calculated as post-dose (Week 24) visit value minus Baseline value. |
| Secondary | Change From Baseline (Day 0) in CogState Battery Overall Composite Score | Baseline (Day 0) and Week 12 (Day 84), Week 24 (Day 168) | CogState battery overall composite score comprised of 8 functional tests 1) Controlled oral word association test measured language fluency, planning and working memory. 2) Category naming test measured semantic fluency, planning and working memory. 3) One-back test measured working memory. 4) Trail B test measured motor speed, visual scanning and visual-motor integration, required attention and cognitive flexibility. 5) Go No-Go task evaluated accuracy and reaction time for each response. 6) International shopping list immediate and delayed recall tests measured episodic memory. 7) Identification task test assessed visual attention. 8) Trail A test measured psychomotor speed and attention. Composite score= total score (sum of all responses from 8 functional test) by formula (Total score at baseline - Week 24) / SD of total score at baseline. Score ranged: -1.070 to 0.907. Lower score indicated the better cognitive status. Change from Baseline= post-dose visit minus Baseline value |
| Secondary | Change From Baseline (Day 0) in CogState Battery Attention Composite Score | Baseline (Day 0) and Week 12 (Day 84), Week 24 (Day 168) | CogState battery attention composite score comprised of 2 functional tests including 1) Identification task test assessed visual attention and 2) Trail A test measured psychomotor speed and attention. Composite score calculated by standardizing the total score (sum of all responses from 2 functional test) by formula (Total score at baseline - Week 24) / SD of total score at baseline. The observed composite score ranged from minimum -1.756 and maximum 1.330. Higher score indicated the better attention. Baseline value was defined as the latest Day 0 value and Change from Baseline was calculated as post-dose visit minus Baseline value |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline (Day 0) in Cerebral Spinal Fluid (CSF) Amyloid Beta Peptide (Abeta) 42 and Abeta40 at Week 24 | Baseline (Day 0) and Week 24 | ITT population. Only those participants available at the specified time points were analyzed. | Nanograms per Liter | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline (Day 0) in CSF Abeta42/ Abeta40 Ratio at Week 24 | Baseline (Day 0) and Week 24 | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Ratio | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline (Day 0) in CSF Tau and Phosphorylated Tau (P-tau) Measures at Week 24 | Baseline (Day 0) and Week 24 | ITT Population. Only those participants available at the specified time points were analyzed. | Nanograms per Liter | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline (Day 0) in the Computerized Test Battery for Cognition (CogState) Battery Working Memory/Executive Function (WM/EF) Composite Score at Week 24 | Baseline (Day 0) and Week 24 | ITT Population. Only those participants with data available at the indicated time points were analyzed. The data is presented in for adjusted mean and standard error of adjusted mean. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline (Day 0) in CSF Albumin Quotients at Week 24 | Baseline (Day 0) and Week 24 | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Nanograms per Liter | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline (Day 0) in Plasma Levels of Abeta42 and Abeta40 at Week 24 | Baseline (Day 0) and Week 24 | ITT Population. Only those participants available at the specified time points were analyzed. | Nanograms per Liter | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline (Day 0) in Plasma Levels of Abeta42/Abeta40 Ratio at Week 24 | Baseline (Day 0) and Week 24 | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Inhibition in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity at Week 24 | Baseline (Day 0) and Week 24 | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Percent change | MEAN |
| SECONDARY | Change From Baseline (Day 0) in CogState Battery Overall Composite Score | Baseline (Day 0) and Week 12 (Day 84), Week 24 (Day 168) | ITT Population. Only those participants available at the specified time points were analyzed. The data is presented in for adjusted mean and standard error of adjusted mean. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline (Day 0) in CogState Battery Attention Composite Score | Baseline (Day 0) and Week 12 (Day 84), Week 24 (Day 168) | ITT Population. Only those participants available at the specified time points were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline (Day 0) in Cerebral Spinal Fluid (CSF) Amyloid Beta Peptide (Abeta) 42 and Abeta40 at Week 24 | Placebo Once Daily | Abeta42 | -6.3 | Standard Error 18.10 | Nanograms per Liter |
| Change From Baseline (Day 0) in Cerebral Spinal Fluid (CSF) Amyloid Beta Peptide (Abeta) 42 and Abeta40 at Week 24 | Rilapladib 250 mg Once Daily | Abeta42 | 33.6 | Standard Error 19.02 | Nanograms per Liter |
| Change From Baseline (Day 0) in Cerebral Spinal Fluid (CSF) Amyloid Beta Peptide (Abeta) 42 and Abeta40 at Week 24 | Placebo Once Daily | Abeta40 | -77.4 | Standard Error 181.33 | Nanograms per Liter |
| Change From Baseline (Day 0) in Cerebral Spinal Fluid (CSF) Amyloid Beta Peptide (Abeta) 42 and Abeta40 at Week 24 | Rilapladib 250 mg Once Daily | Abeta40 | -327.7 | Standard Error 190.56 | Nanograms per Liter |
| Change From Baseline (Day 0) in CSF Abeta42/ Abeta40 Ratio at Week 24 | Placebo Once Daily | 0.002 | Standard Error 0.0068 | Ratio | |
| Change From Baseline (Day 0) in CSF Abeta42/ Abeta40 Ratio at Week 24 | Rilapladib 250 mg Once Daily | 0.018 | Standard Error 0.0071 | Ratio | |
| Change From Baseline (Day 0) in CSF Tau and Phosphorylated Tau (P-tau) Measures at Week 24 | Placebo Once Daily | CSF tau | 38.2 | Standard Error 29.98 | Nanograms per Liter |
| Change From Baseline (Day 0) in CSF Tau and Phosphorylated Tau (P-tau) Measures at Week 24 | Rilapladib 250 mg Once Daily | CSF tau | -18.8 | Standard Error 31.90 | Nanograms per Liter |
| Change From Baseline (Day 0) in CSF Tau and Phosphorylated Tau (P-tau) Measures at Week 24 | Placebo Once Daily | P-tau | 1.3 | Standard Error 1.67 | Nanograms per Liter |
| Change From Baseline (Day 0) in CSF Tau and Phosphorylated Tau (P-tau) Measures at Week 24 | Rilapladib 250 mg Once Daily | P-tau | -1.7 | Standard Error 1.76 | Nanograms per Liter |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Once Daily | 62 | |
| Overall Study | STARTED | Rilapladib 250 mg Once Daily | 61 | |
| Overall Study | COMPLETED | Placebo Once Daily | 56 | |
| Overall Study | COMPLETED | Rilapladib 250 mg Once Daily | 52 | |
| Overall Study | NOT COMPLETED | Placebo Once Daily | 6 | |
| Overall Study | NOT COMPLETED | Rilapladib 250 mg Once Daily | 9 |
Source ClinicalTrials.gov
Adverse events40
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 | Headache | Nervous system disorders | Placebo Once Daily | 10 | 62 | 10 |
| other | Headache | Nervous system disorders | Rilapladib 250mg Once Daily | 3 | 61 | 3 |
| other | Nausea | Gastrointestinal disorders | Placebo Once Daily | 5 | 62 | 9 |
| other | Nausea | Gastrointestinal disorders | Rilapladib 250mg Once Daily | 2 | 61 | 2 |
| other | Urinary tract infection | Infections and infestations | Placebo Once Daily | 6 | 62 | 7 |
| other | Urinary tract infection | Infections and infestations | Rilapladib 250mg Once Daily | 1 | 61 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Once Daily | 2 | 62 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Rilapladib 250mg Once Daily | 4 | 61 | 4 |
| other | Dizziness | Nervous system disorders | Placebo Once Daily | 4 | 62 | 6 |
| other | Dizziness | Nervous system disorders | Rilapladib 250mg Once Daily | 2 | 61 | 2 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Once Daily | 1 | 62 |
| Total, all-cause mortality | Rilapladib 250mg Once Daily | 1 | 61 |
| Total, other adverse events | Placebo Once Daily | 23 | 62 |
| Total, other adverse events | Rilapladib 250mg Once Daily | 16 | 61 |
| Total, serious adverse events | Placebo Once Daily | 5 | 62 |
| Total, serious adverse events | Rilapladib 250mg Once Daily | 8 | 61 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29854933 | DERIVED |
Source PubMed
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 |
|---|---|
| Rilapladib 250mg Once Daily vs Placebo Once Daily: deaths from any cause | Trial comparisons |
| Rilapladib 250mg Once Daily vs Placebo Once Daily: serious adverse events | Trial comparisons |
Tests4
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 | Source |
|---|---|---|
| 1-Back Task | Primary outcome | ConductCognition |
| Category Fluency | Primary outcome | ConductCognition |
| Go/No-Go Task | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT01428453
GET https://conductscience.org/api/trials/v1/NCT01428453/results?page=2