Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
rilapladib · 3 trials · 3 indications
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| 250mg rilapladib | EXPERIMENTAL | Experimental drug |
| placebo | PLACEBO_COMPARATOR | Placebo comparator |
| rilapladib | ACTIVE_COMPARATOR | 250 mg/day |
| Name | Type | Description |
|---|---|---|
| 250mg rilapladib | DRUG | Experimental Drug |
| placebo | DRUG | Placebo comparator |
| rilapladib | DRUG | 250 mg oral dose once daily |
| 18F Fluorodeoxylucose (FDG)-PET | OTHER | FDG-PET |
| Rilapladib (SB-659032) | DRUG | - |
Inclusion Criteria: 1. A clinical diagnosis of possible Alzheimer's disease in accordance with the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with radiological (Magnetic Resonance Imaging \[...
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Rilapladib is an investigational small molecule being studied for Alzheimer's Disease, Atherosclerosis, and in Healthy Subjects. It has been evaluated in clinical trials for these conditions, though it remains in clinical development and is not approved.
Rilapladib is being developed by GSK plc, which trades under the ticker GSK. The company has sponsored clinical trials of the drug in conditions including atherosclerosis and Alzheimer's disease.
Rilapladib has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug still in clinical development, and it is not approved for any use. The most advanced trials completed were Phase 2 studies.
Rilapladib has been studied in completed trials including NCT00387257, a Phase 1 study on platelet aggregation in healthy subjects and atherosclerosis; NCT00695305, a Phase 2 imaging study in atherosclerosis; and NCT01428453, a Phase 2a study in Alzheimer's disease.
Yes, Rilapladib is also known as SB-659032. Clinical trial titles for the drug refer to it as Rilapladib (SB-659032), confirming that both names identify the same investigational compound.