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Rosiglitazone (Extended Release Tablets) As Monotherapy In Subjects With Mild To Moderate Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00428090
First received: January 25, 2007
Last updated: April 13, 2017
Last verified: April 2017
Results First Received: February 16, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Intervention: Drug: Rosiglitazone

  Participant Flow
  Hide 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 (par.) were enrolled across 134 centres Austria, Bulgaria, Chile, China, Crotia, Estonia, Germany, Greece, Hungry, Korea, Mexico, New Zealand, Pakistan, Peru, Philippines, Puerto Rico, Russia, the United Kingdom and the United States from February 2007 to September 2008. The total study duration was 30 weeks (W).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Total of 639 par. were screened out of which 581 were randomized and 58 were placebo run-in failures. Analysis population included 579 par. of 581 randomized participants as 2 par. did not take study drug: 1 from placebo and 1 from donepezil arm.

Reporting Groups
  Description
Placebo Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
RSG XR 2 mg Par. in this arm received rosiglitazone extended release (RSGXR) 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
RSG XR 8 mg Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
Donepezil 10 mg Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.

Participant Flow:   Overall Study
    Placebo   RSG XR 2 mg   RSG XR 8 mg   Donepezil 10 mg
STARTED   165   166   165   83 
COMPLETED   131   135   127   55 
NOT COMPLETED   34   31   38   28 
Adverse Event                10                8                10                11 
Lost to Follow-up                3                6                1                4 
Protocol Violation                3                1                3                3 
Withdrawal by Subject                10                12                15                5 
Sponsor terminated study                0                1                0                0 
Non-compliance                4                0                1                3 
Par. did not returned to visit                1                0                0                1 
Follow-Up visit not possible                1                0                0                0 
Prohibited medication used for SAE                1                0                0                0 
Death of par.                1                0                1                0 
Visit 7 exceed the visit window                0                1                0                0 
Medical monitor terminated par.                0                1                0                0 
Mental status of par. was                0                1                0                0 
Worsening of AD                0                0                1                0 
Excluded for concerning QTc value                0                0                1                0 
Insufficient AD documentation                0                0                1                0 
High MMSE scores                0                0                1                0 
Deterioration of cognitive status                0                0                1                0 
Serious adverse event                0                0                1                0 
Excluded for heart insufficiency                0                0                1                0 
Raised Creatinine Value                0                0                0                1 



  Baseline Characteristics
  Hide 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 intent-to-treat (ITT) population was used and consist of all par. randomized to treatment, who have taken at least one dose of study medication and who have at least one post baseline efficacy assessment. The ITT population included 553 participants.

Reporting Groups
  Description
Placebo Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
RSG XR 2 mg Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
RSG XR 8 mg Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
Donepezil 10 mg Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
Total Total of all reporting groups

Baseline Measures
   Placebo   RSG XR 2 mg   RSG XR 8 mg   Donepezil 10 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 159   162   156   76   553 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 72.5  (8.56)   71.7  (7.91)   72.6  (8.63)   72.9  (7.97)   72.4  (8.30) 
[1] Baseline data are presented for intention-to-Treat (ITT) population which defined as par. randomized to treatment, who have taken at least one dose of study medication and who have at least one post baseline efficacy assessment (Alzheimer’s Disease Assessment Scale – Cognitive subscale [ADAS-Cog] or Clinician’s Interview-Based Impression of Change Plus [CIBIC+]).
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
         
Female      95  59.7%      103  63.6%      101  64.7%      48  63.2%      347  62.7% 
Male      64  40.3%      59  36.4%      55  35.3%      28  36.8%      206  37.3% 
[1] ITT Population
Race (NIH/OMB) [1] 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      1   0.6%      1   0.6%      2   1.3%      0   0.0%      4   0.7% 
Asian      33  20.8%      50  30.9%      37  23.7%      14  18.4%      134  24.2% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   0.6%      1   0.6%      2   1.3%      3   3.9%      7   1.3% 
White      123  77.4%      109  67.3%      112  71.8%      57  75.0%      401  72.5% 
More than one race      1   0.6%      1   0.6%      3   1.9%      2   2.6%      7   1.3% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
[1] ITT Population


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in Apolipoprotein epsilon4 (APOE e4) Negative Cohort   [ Time Frame: Baseline (W0) and W24 ]

2.  Primary:   Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in All Except e4/e4’s Cohort   [ Time Frame: Baseline (W0) and W24 ]

3.  Primary:   Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in Full Population Cohort   [ Time Frame: Baseline (W0) and W24 ]

4.  Primary:   Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in APOE4 Negative Cohort   [ Time Frame: Baseline (W0) and W24 ]

5.  Primary:   Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in All Except e4/e4’s Cohort   [ Time Frame: Baseline (W0) and W24 ]

6.  Primary:   Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in Full Population Cohort   [ Time Frame: Baseline (W0) and W24 ]

7.  Secondary:   Change From Baseline (W0) in Mean ADAS-Cog Total Score at W8, W16, W24   [ Time Frame: Baseline (W0) and up to W24 ]

8.  Secondary:   Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W8, W16, W24   [ Time Frame: Baseline (W0) and up to W24 ]

9.  Secondary:   Change From Baseline (W0) in Mean Neuropsychiatric Inventory (NPI) Total Score at W8, W16, W24   [ Time Frame: Baseline (W0) and up to W24 ]

10.  Secondary:   Change From Baseline (W0) in Mean Disability Assessment for Dementia (DAD) Scale Total Score at W8, W16, W24   [ Time Frame: Baseline (W0) and up to W24 ]

11.  Secondary:   Change From Baseline (W0) in Mean Short Term Memory Assessment Total Score (ADAS-Cog Q1 Plus Q7) at W8, W16, W24   [ Time Frame: Baseline (W0) and up to W24 ]

12.  Secondary:   Change From Baseline (W0) in Mean European Quality of Life -5 Dimensions Proxy Version (EQ-5D Proxy) Total Score at W12, W24 Assessed by Utility   [ Time Frame: Baseline (W0) and up to W24 ]

13.  Secondary:   Change From Baseline (W0) in Mean European Quality of Life -5 Dimensions Proxy Version (EQ-5D Proxy) Total Score at W12, W24 Assessed by Thermometer (Visual Analog Scale [VAS])   [ Time Frame: Baseline (W0) and up to W24 ]

14.  Secondary:   Time Spent Caring for Basic and Instrumental Activities Resource Utilization in Dementia (RUD) Scale at W12 and W24   [ Time Frame: Baseline (W0) and up to W24 ]

15.  Secondary:   Change From Baseline (W0) in Alzheimer’s Carer’s Quality of Life Instrument (ACQLI) Score at W12 and W24.   [ Time Frame: Baseline (W0) and up to W24 ]

16.  Secondary:   Change From Baseline (W0) in Mini Mental State Examination (MMSE) Total Score at W24.   [ Time Frame: Baseline (W0) and W24 ]

17.  Secondary:   Change From Baseline (W0) in Glycosylated Hemoglobin (HbA1c) at W24.   [ Time Frame: Baseline (W0) and W24 ]

18.  Secondary:   Number of Participants With Adverse Events Defined by Severity   [ Time Frame: Up to W24 ]

19.  Secondary:   Number of Participants With Systolic and Diastolic Blood Pressure (SBP and DBP), Heart Rate (HR) and Weight Values of Potential Clinical Concern (PCC) Any Time on Treatment (ATOT).   [ Time Frame: Up to W24 ]

20.  Secondary:   Change From Baseline (W0) in 12-lead Electrocardiogram (ECG)   [ Time Frame: Baseline (W0) and up to W24 ]

21.  Secondary:   Change From Baseline (W0) in Heart Rate (HR) Measured From 12-lead Electrocardiogram (ECG)   [ Time Frame: Baseline (W0) and up to W24 ]

22.  Secondary:   Change From Baseline (W0) in Body Weight   [ Time Frame: Baseline (W0) and up to W24 ]

23.  Secondary:   Change From Baseline (W0) in Hemoglobin   [ Time Frame: Baseline (W0) and up to W24 ]

24.  Secondary:   Change From Baseline (W0) in Hematocrit   [ Time Frame: Baseline (W0) and Up to W24 ]

25.  Secondary:   Change From Baseline (W0) in Periodic HbA1c Assessment   [ Time Frame: Baseline (W0) and up to W24 ]

26.  Secondary:   Number of Par. With Hematology Data of Potential Clinical Concern Any Time on Treatment   [ Time Frame: Up to W24 ]

27.  Secondary:   Number of Par. With Clinical Chemistry Values of Potential Clinical Concern Any Time on Treatment   [ Time Frame: Up to W24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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  More Information
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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:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00428090     History of Changes
Other Study ID Numbers: 105640
Study First Received: January 25, 2007
Results First Received: February 16, 2017
Last Updated: April 13, 2017