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Trial record 6 of 15 for:    Alzheimer rosiglitazone

Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers

This study has been terminated.
(Based on preliminary parent study results)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00490568
First Posted: June 22, 2007
Last Update Posted: November 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: September 5, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Intervention: Drug: Rosiglitazone XR

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A open-label extension study to evaluate the long-term safety and tolerability of rosiglitazone extended-release (RSG XR) tablets in participants with mild-to moderate Alzheimer’s Disease conducted in a total of 29 countries across 267 centers from 08 August 2007 to 30 May 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Approximately 1800 participants were planned to be enrolled however a total of 1461 participants (after completing parent studies AVA102670/AVA102672) were enrolled and received open-label RSG-XR tablets.

Reporting Groups
  Description
RSG XR Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of Acetylcholinesterase Inhibitor (AChEI) for Alzheimer’s disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received oral 4 milligram (mg) once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.

Participant Flow:   Overall Study
    RSG XR
STARTED   1461 
COMPLETED   97 
NOT COMPLETED   1364 
Adverse Event                116 
Lost to Follow-up                13 
Protocol Violation                45 
Withdrawal by Subject                135 
Still in the study at termination                974 
Other                1 
Exclusion criteria met                1 
Caregiver related                20 
Abnormal ECG                25 
Participant refused follow-up                9 
Legal representative withdrew consent                1 
Disease progression                4 
Unmet inclusion-exclusion criteria                5 
Investigator decision                3 
Non-Compliance                7 
Efficacy related                3 
Participant died                1 
Participant withdrawal due to surgery                1 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
RSG XR (AVA102675) Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer’s disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.

Baseline Measures
   RSG XR (AVA102675) 
Overall Participants Analyzed 
[Units: Participants]
 1461 
Age 
[Units: Years]
Mean (Standard Deviation)
 73.9  (7.96) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      843  57.7% 
Male      618  42.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      6   0.4% 
Asian      52   3.6% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      7   0.5% 
White      1396  95.6% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Any Adverse Events (AEs) and Severity of AEs   [ Time Frame: Up to 76 Weeks ]

2.  Secondary:   Number Participants With Serious Adverse Events (SAEs) and Deaths   [ Time Frame: Up to 76 Weeks ]

3.  Secondary:   Number of Participants With Adverse Event of Oedema   [ Time Frame: Up to 76 Weeks ]

4.  Secondary:   Change From Baseline in Vital Sign Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)   [ Time Frame: Up to 70 Weeks (including follow up) ]

5.  Secondary:   Change From Baseline in Vital Sign Heart Rate (HR)   [ Time Frame: Up to 70 Weeks (including follow up) ]

6.  Secondary:   Change From Baseline in Vital Sign Body Weight (BW)   [ Time Frame: Up to 70 Weeks (including follow up) ]

7.  Secondary:   Change From Baseline in Non-fasting Measures of Lipid Metabolism Namely Total Cholesterol (TC), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides   [ Time Frame: Up to 82 Weeks (including follow up) ]

8.  Secondary:   Number of Participants With SBP and DBP Values of Potential Clinical Concern (PCC)   [ Time Frame: Up to 70 Weeks (including follow up) ]

9.  Secondary:   Number of Participants With HR Values of PCC ATOT   [ Time Frame: Up to 70 Weeks (including follow up) ]

10.  Secondary:   Number of Participants With BW Values of PCC ATOT   [ Time Frame: Up to 70 Weeks (including follow up) ]

11.  Secondary:   Number of Participants With Hematology Parameters of PCC ATOT   [ Time Frame: Up to Week 82 (including follow up) ]

12.  Secondary:   Number of Participants With Clinical Chemistry Parameters (Including Lipids) of PCC ATOT   [ Time Frame: Up to Week 82 (including follow up) ]

13.  Secondary:   Change From Baseline in Alzheimer's Disease Assessment Scale – Cognitive (ADAS-cog) Total Score as a Function of Apolipoprotein E (APOE) ε4 Status.   [ Time Frame: Baseline (Week 0) and Week 24, 52 ]

14.  Secondary:   Change From Baseline in Clinical Dementia Rating Scale–Sum of Boxes (CDR-SB) Score as a Function of APOE ε4 Status.   [ Time Frame: Baseline (Week 0) and Week 24, 52 ]

15.  Secondary:   Change From Baseline in Mini Mental State Examination (MMSE) Total Score as a Function of APOE ε4 Status.   [ Time Frame: Baseline (Week 0) and Week 24, 52 ]

16.  Secondary:   Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score as a Function of APOE ε4 Status.   [ Time Frame: Baseline (Week 0) and Week 24, 52 ]

17.  Secondary:   Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score as a Function of APOE ε4 Status.   [ Time Frame: Baseline (Week 0) and Week 24, 52 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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: NCT00490568     History of Changes
Other Study ID Numbers: AVA102675
First Submitted: June 21, 2007
First Posted: June 22, 2007
Results First Submitted: September 5, 2017
Results First Posted: November 10, 2017
Last Update Posted: November 10, 2017