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A Phase 2a Study to Evaluate the Effect of Rilapladib (SB-659032) in Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT01428453
Recruitment Status : Completed
First Posted : September 5, 2011
Results First Posted : September 24, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Drug: 250mg rilapladib
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants with Alzheimer’s disease (AD) were randomized to either rilapladib or placebo from October-2011 to February-2013. The study duration was approximately 30 weeks (screening: 4 weeks, treatment: 24 weeks and follow-up: 2 weeks).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Total of 170 participants were screened, of which 124 were randomized in 24 centres. Out of 124 participants, one was excluded from safety population due to randomization error. Out of 123 participants, 2 were excluded due to unavailability of post-baseline efficacy data. Intention to treat (ITT) population consisted of 121 participants.

Reporting Groups
  Description
Placebo Once Daily Participants randomized to receive oral placebo tablet once daily following breakfast for a period of 24 weeks. In addition, to their stable background therapy consisting of an acetylcholinesterase inhibitor (AChEI) and/or memantine.
Rilapladib 250 mg Once Daily Participants randomized to receive oral rilapladib 250 milligrams (mg) tablet once daily following breakfast for a period of 24 weeks. In addition, to their stable background therapy consisting of an AChEI and/or memantine.

Participant Flow:   Overall Study
    Placebo Once Daily   Rilapladib 250 mg Once Daily
STARTED   62   61 
COMPLETED   56   52 
NOT COMPLETED   6   9 
Adverse Event                2                7 
Protocol Violation                1                0 
Lost to Follow-up                0                1 
Withdrawal by Subject                3                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The data for ITT population is presented and defined as participants who were randomized, received at least one dose of study medication and had at least one non-missing post Baseline efficacy assessment. One participant from each group was excluded from ITT population as no post-baseline efficacy data available and total ITT population was 121.

Reporting Groups
  Description
Placebo Once Daily Participants randomized to receive oral placebo tablet once daily following breakfast for a period of 24 weeks. In addition to their stable background therapy consisting of an AChEI and/or memantine.
Rilapladib 250 mg Once Daily Participants randomized to receive oral rilapladib 250 mg tablet once daily following breakfast for a period of 24 weeks. In addition to their stable background therapy consisting of an AChEI and/or memantine.
Total Total of all reporting groups

Baseline Measures
   Placebo Once Daily   Rilapladib 250 mg Once Daily   Total 
Overall Participants Analyzed 
[Units: Participants]
 61   60   121 
Age 
[Units: Years]
Mean (Standard Deviation)
 73.1  (5.40)   72.9  (5.15)   73.0  (5.26) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      28  45.9%      32  53.3%      60  49.6% 
Male      33  54.1%      28  46.7%      61  50.4% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White - White/Caucasian/European Heritage   61   60   121 


  Outcome Measures

1.  Primary:   Change From Baseline (Day 0) in Cerebral Spinal Fluid (CSF) Amyloid Beta Peptide (Abeta) 42 and Abeta40 at Week 24   [ Time Frame: Baseline (Day 0) and Week 24 ]

2.  Primary:   Change From Baseline (Day 0) in CSF Abeta42/ Abeta40 Ratio at Week 24   [ Time Frame: Baseline (Day 0) and Week 24 ]

3.  Primary:   Change From Baseline (Day 0) in CSF Tau and Phosphorylated Tau (P-tau) Measures at Week 24   [ Time Frame: Baseline (Day 0) and Week 24 ]

4.  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   [ Time Frame: Baseline (Day 0) and Week 24 ]

5.  Secondary:   Change From Baseline (Day 0) in CSF Albumin Quotients at Week 24   [ Time Frame: Baseline (Day 0) and Week 24 ]

6.  Secondary:   Change From Baseline (Day 0) in Plasma Levels of Abeta42 and Abeta40 at Week 24   [ Time Frame: Baseline (Day 0) and Week 24 ]

7.  Secondary:   Change From Baseline (Day 0) in Plasma Levels of Abeta42/Abeta40 Ratio at Week 24   [ Time Frame: Baseline (Day 0) and Week 24 ]

8.  Secondary:   Percentage Inhibition in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity at Week 24   [ Time Frame: Baseline (Day 0) and Week 24 ]

9.  Secondary:   Change From Baseline (Day 0) in CogState Battery Overall Composite Score   [ Time Frame: Baseline (Day 0) and Week 12 (Day 84), Week 24 (Day 168) ]

10.  Secondary:   Change From Baseline (Day 0) in CogState Battery Attention Composite Score   [ Time Frame: Baseline (Day 0) and Week 12 (Day 84), Week 24 (Day 168) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01428453     History of Changes
Other Study ID Numbers: 114458
First Submitted: September 1, 2011
First Posted: September 5, 2011
Results First Submitted: March 7, 2017
Results First Posted: September 24, 2018
Last Update Posted: September 24, 2018