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Study Of Rosiglitazone XR In Subjects With Mild-to-Moderate Alzheimers

This study has been terminated.
(Based on preliminary parent study results)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00550420
First Posted: October 29, 2007
Last Update Posted: November 8, 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: August 31, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   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 total of 331 participants who had completed the double-blind treatment phase in AVA105640 were enrolled. Only 26 participants completed the study as it was early terminated, 206 participants were still enrolled at the time of study termination while 97 participants withdrew prematurely. The study completion status of 2 participants was missing.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The enrolled participants had successfully completed Visit 8 of AVA105640 without safety/tolerability issues. For safety endpoints, ‘baseline’ referred to the current study baseline assessment, (AVA102677 Visit 1). For efficacy endpoints, the term ‘baseline’ referred to the baseline assessment of the parent study (AVA105640), Visit 3.

Reporting Groups
  Description
RSG XR 8 mg Participants received rosiglitazone extended-release (RSG XR) 4 milligram (mg) tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.

Participant Flow:   Overall Study
    RSG XR 8 mg
STARTED   331 
COMPLETED   26 
NOT COMPLETED   305 
Adverse Event                28 
Lost to Follow-up                8 
Protocol Violation                11 
Withdrawal by Subject                30 
Still in study at termination                206 
Missing                2 
Prolonged QT Interval Electrocardiogram                12 
Investigators opinion                1 
Lack of curative effect                1 
Unethical stop of enrollment                2 
Caregiver's decision to withdraw                1 
Out of Electrocardiogram criteria                1 
Exclusion criteria                1 
Prohibited medicine                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 8 mg Participants received RSG XR 4mg tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.

Baseline Measures
   RSG XR 8 mg 
Overall Participants Analyzed 
[Units: Participants]
 331 
Age 
[Units: Years]
Mean (Standard Deviation)
 72.8  (7.95) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      206  62.2% 
Male      125  37.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      3   0.9% 
Asian      85  25.7% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      242  73.1% 
More than one race      1   0.3% 
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 Week 82 ]

2.  Secondary:   Number of Participants With Serious AEs and Deaths   [ Time Frame: Up to Week 82 ]

3.  Secondary:   Percentage of Participants With AEs of Edema   [ Time Frame: Up to 82 Weeks ]

4.  Secondary:   Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)   [ Time Frame: Baseline (Visit 1, W0), W4, W8, W12, W16, W24, W36, W52, W64 and Follow-up (W82) ]

5.  Secondary:   Change From Baseline in Heart Rate (HR)   [ Time Frame: Baseline (Visit 1, W0), W4, W8, W12, W16, W24, W36, W52, W64 and Follow-up (W82) ]

6.  Secondary:   Number of Participants With Abnormal SBP and DBP at Any Time During Treatment Period   [ Time Frame: Up to 82 weeks ]

7.  Secondary:   Number of Participants With Abnormal HR at Any Time During Treatment Period   [ Time Frame: Up to 82 weeks ]

8.  Secondary:   Change From Baseline in Body Weight (BW)   [ Time Frame: Baseline (Visit 1, W0), W4, W8, W12, W16, W24, W36, W52, W64 and Follow-up (W82) ]

9.  Secondary:   Number of Participants With Abnormal BW at Any Time During Treatment Period   [ Time Frame: Baseline (Visit 1, W0) to W 52 ]

10.  Secondary:   Change From Baseline in Non-fasting Measures of Lipid Metabolism Including Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein and Triglycerides at Indicated Timepoints.   [ Time Frame: Baseline (Visit 1, W0), W4, W16, W36, W52, W76, and W82 ]

11.  Secondary:   Number of Participants With Hematological Parameters of Potential Clinical Concern   [ Time Frame: Up to 82 weeks ]

12.  Secondary:   Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern   [ Time Frame: Up to 82 weeks ]

13.  Secondary:   Change From Baseline in Alzheimer's Disease Assessment Scale – Cognitive (ADAS-Cog) Total Score as a Function of Apolipoprotein E (APOE) 4 Status at W24 and W52   [ Time Frame: Baseline (Visit 1, W0), W24 and W52 ]

14.  Secondary:   Mean Clinician Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Score as a Function of APOE 4 Status   [ Time Frame: Baseline (Visit 1, W0), W 24 and W 52 ]

15.  Secondary:   Change From Baseline in Mini Mental State Examination (MMSE) Total Score as a Function of APOE 4 Status at W24 and W52   [ Time Frame: Baseline (Visit 1, W0), W 24 and W52 ]

16.  Secondary:   Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score as a Function of APOEe 4 Status   [ Time Frame: Baseline (Visit 1, W0), W24 and W52 ]

17.  Secondary:   Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score as a Function of APOE 4 Status at W24 and W52   [ Time Frame: Baseline (Visit 1, W0), W24 and W52 ]

18.  Secondary:   Change From Baseline in Glycosylated Haemoglobin (HbA1c)   [ Time Frame: Baseline (Vsit 1 W0), W12, W24, W36, W52, W76 and Follow-up (W82) ]


  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
The study was early terminated on 12 February 2009 because RSG XR as monotherapy in Alzheimer’s disease failed to demonstrate efficacy.


  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: NCT00550420     History of Changes
Other Study ID Numbers: AVA102677
First Submitted: October 25, 2007
First Posted: October 29, 2007
Results First Submitted: August 31, 2017
Results First Posted: November 8, 2017
Last Update Posted: November 8, 2017