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Trial record 27 of 31 for:    alzheimer dijon

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

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ClinicalTrials.gov Identifier: NCT00490568
Recruitment Status : Terminated (Based on preliminary parent study results)
First Posted : June 22, 2007
Results First Posted : November 13, 2017
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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

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

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

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

Time Frame Up to 76 Weeks
Additional Description All subject (Full population) was used for analysis.

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 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.

Serious Adverse Events
    RSG XR
Total, All-Cause Mortality   
# participants affected / at risk   20/1461 (1.37%) 
Total, Serious Adverse Events   
# participants affected / at risk   126/1461 (8.62%) 
Blood and lymphatic system disorders   
Anaemia † 1   
# participants affected / at risk   5/1461 (0.34%) 
Iron deficiency anaemia † 1   
# participants affected / at risk   1/1461 (0.07%) 
Cardiac disorders   
Myocardial infarction † 1   
# participants affected / at risk   3/1461 (0.21%) 
Acute myocardial infarction † 1   
# participants affected / at risk   2/1461 (0.14%) 
Atrial fibrillation † 1   
# participants affected / at risk   2/1461 (0.14%) 
Angina pectoris † 1   
# participants affected / at risk   1/1461 (0.07%) 
Atrial flutter † 1   
# participants affected / at risk   1/1461 (0.07%) 
Cardiac failure congestive † 1   
# participants affected / at risk   1/1461 (0.07%) 
Cardio-respiratory arrest † 1   
# participants affected / at risk   1/1461 (0.07%) 
Coronary artery disease † 1   
# participants affected / at risk   1/1461 (0.07%) 
Myocardial ischaemia † 1   
# participants affected / at risk   1/1461 (0.07%) 
Sinus arrhythmia † 1   
# participants affected / at risk   1/1461 (0.07%) 
Gastrointestinal disorders   
Haematemesis † 1   
# participants affected / at risk   1/1461 (0.07%) 
Intestinal obstruction † 1   
# participants affected / at risk   1/1461 (0.07%) 
Large intestine perforation † 1   
# participants affected / at risk   1/1461 (0.07%) 
Lumbar hernia † 1   
# participants affected / at risk   1/1461 (0.07%) 
Peritonitis † 1   
# participants affected / at risk   1/1461 (0.07%) 
Colonic polyp † 1   
# participants affected / at risk   1/1461 (0.07%) 
General disorders   
Death † 1   
# participants affected / at risk   1/1461 (0.07%) 
General physical health deterioration † 1   
# participants affected / at risk   1/1461 (0.07%) 
Oedema peripheral † 1   
# participants affected / at risk   1/1461 (0.07%) 
Hepatobiliary disorders   
Bile duct stone † 1   
# participants affected / at risk   1/1461 (0.07%) 
Cholangitis † 1   
# participants affected / at risk   1/1461 (0.07%) 
Cholecystitis † 1   
# participants affected / at risk   1/1461 (0.07%) 
Infections and infestations   
Pneumonia † 1   
# participants affected / at risk   5/1461 (0.34%) 
Bronchopneumonia † 1   
# participants affected / at risk   2/1461 (0.14%) 
Urinary tract infection † 1   
# participants affected / at risk   2/1461 (0.14%) 
Cellulitis † 1   
# participants affected / at risk   1/1461 (0.07%) 
Diverticulitis † 1   
# participants affected / at risk   1/1461 (0.07%) 
Respiratory tract infection viral † 1   
# participants affected / at risk   1/1461 (0.07%) 
Injury, poisoning and procedural complications   
Fall † 1   
# participants affected / at risk   4/1461 (0.27%) 
Femur fracture † 1   
# participants affected / at risk   3/1461 (0.21%) 
Humerus fracture † 1   
# participants affected / at risk   2/1461 (0.14%) 
Skin laceration † 1   
# participants affected / at risk   2/1461 (0.14%) 
Spinal compression fracture † 1   
# participants affected / at risk   2/1461 (0.14%) 
Drug toxicity † 1   
# participants affected / at risk   1/1461 (0.07%) 
Femoral neck fracture † 1   
# participants affected / at risk   1/1461 (0.07%) 
Fracture † 1   
# participants affected / at risk   1/1461 (0.07%) 
Head injury † 1   
# participants affected / at risk   1/1461 (0.07%) 
Hip fracture † 1   
# participants affected / at risk   1/1461 (0.07%) 
Injury † 1   
# participants affected / at risk   1/1461 (0.07%) 
Lumbar vertebral fracture † 1   
# participants affected / at risk   1/1461 (0.07%) 
Pacemaker complication † 1   
# participants affected / at risk   1/1461 (0.07%) 
Soft tissue injury † 1   
# participants affected / at risk   1/1461 (0.07%) 
Subdural haematoma † 1   
# participants affected / at risk   1/1461 (0.07%) 
Subdural haemorrhage † 1   
# participants affected / at risk   1/1461 (0.07%) 
Traumatic fracture † 1   
# participants affected / at risk   1/1461 (0.07%) 
Upper limb fracture † 1   
# participants affected / at risk   1/1461 (0.07%) 
Wrist fracture † 1   
# participants affected / at risk   1/1461 (0.07%) 
Investigations   
Blood sodium increased † 1   
# participants affected / at risk   1/1461 (0.07%) 
Weight increased † 1   
# participants affected / at risk   1/1461 (0.07%) 
Metabolism and nutrition disorders   
Dehydration † 1   
# participants affected / at risk   1/1461 (0.07%) 
Hypokalaemia † 1   
# participants affected / at risk   1/1461 (0.07%) 
Musculoskeletal and connective tissue disorders   
Osteoarthritis † 1   
# participants affected / at risk   2/1461 (0.14%) 
Foot deformity † 1   
# participants affected / at risk   1/1461 (0.07%) 
Osteoporotic fracture † 1   
# participants affected / at risk   1/1461 (0.07%) 
Synovial disorder † 1   
# participants affected / at risk   1/1461 (0.07%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer † 1   
# participants affected / at risk   2/1461 (0.14%) 
Brain cancer metastatic † 1   
# participants affected / at risk   1/1461 (0.07%) 
Brain neoplasm † 1   
# participants affected / at risk   1/1461 (0.07%) 
Colon cancer † 1   
# participants affected / at risk   1/1461 (0.07%) 
Endometrial cancer † 1   
# participants affected / at risk   1/1461 (0.07%) 
Lung neoplasm † 1   
# participants affected / at risk   1/1461 (0.07%) 
Metastases to bone † 1   
# participants affected / at risk   1/1461 (0.07%) 
Ovarian cancer † 1   
# participants affected / at risk   1/1461 (0.07%) 
Paget's disease of the breast † 1   
# participants affected / at risk   1/1461 (0.07%) 
Prostate cancer † 1   
# participants affected / at risk   1/1461 (0.07%) 
Refractory anaemia † 1   
# participants affected / at risk   1/1461 (0.07%) 
Nervous system disorders   
Cerebrovascular accident † 1   
# participants affected / at risk   4/1461 (0.27%) 
Syncope † 1   
# participants affected / at risk   4/1461 (0.27%) 
Dementia † 1   
# participants affected / at risk   2/1461 (0.14%) 
Dementia Alzheimer's type † 1   
# participants affected / at risk   2/1461 (0.14%) 
Transient ischaemic attack † 1   
# participants affected / at risk   2/1461 (0.14%) 
Cerebral haemorrhage † 1   
# participants affected / at risk   1/1461 (0.07%) 
Coma † 1   
# participants affected / at risk   1/1461 (0.07%) 
Convulsion † 1   
# participants affected / at risk   1/1461 (0.07%) 
Dizziness † 1   
# participants affected / at risk   1/1461 (0.07%) 
Epilepsy † 1   
# participants affected / at risk   1/1461 (0.07%) 
Ischaemic stroke † 1   
# participants affected / at risk   1/1461 (0.07%) 
Loss of consciousness † 1   
# participants affected / at risk   1/1461 (0.07%) 
Nerve root compression † 1   
# participants affected / at risk   1/1461 (0.07%) 
Optic neuritis † 1   
# participants affected / at risk   1/1461 (0.07%) 
Subarachnoid haemorrhage † 1   
# participants affected / at risk   1/1461 (0.07%) 
Thalamic infarction † 1   
# participants affected / at risk   1/1461 (0.07%) 
Psychiatric disorders   
Aggression † 1   
# participants affected / at risk   3/1461 (0.21%) 
Delirium † 1   
# participants affected / at risk   2/1461 (0.14%) 
Agitation † 1   
# participants affected / at risk   1/1461 (0.07%) 
Behavioural and psychiatric symptoms of dementia † 1   
# participants affected / at risk   1/1461 (0.07%) 
Confusional state † 1   
# participants affected / at risk   1/1461 (0.07%) 
Hallucination † 1   
# participants affected / at risk   1/1461 (0.07%) 
Mental status changes † 1   
# participants affected / at risk   1/1461 (0.07%) 
Panic disorder † 1   
# participants affected / at risk   1/1461 (0.07%) 
Sleep disorder † 1   
# participants affected / at risk   1/1461 (0.07%) 
Renal and urinary disorders   
Nephrotic syndrome † 1   
# participants affected / at risk   1/1461 (0.07%) 
Urinary retention † 1   
# participants affected / at risk   1/1461 (0.07%) 
Reproductive system and breast disorders   
Benign prostatic hyperplasia † 1   
# participants affected / at risk   1/1461 (0.07%) 
Uterine prolapse † 1   
# participants affected / at risk   1/1461 (0.07%) 
Respiratory, thoracic and mediastinal disorders   
Lung disorder † 1   
# participants affected / at risk   1/1461 (0.07%) 
Pulmonary embolism † 1   
# participants affected / at risk   1/1461 (0.07%) 
Skin and subcutaneous tissue disorders   
Skin ulcer † 1   
# participants affected / at risk   1/1461 (0.07%) 
Vascular disorders   
Circulatory collapse † 1   
# participants affected / at risk   2/1461 (0.14%) 
Peripheral arterial occlusive disease † 1   
# participants affected / at risk   1/1461 (0.07%) 
Post thrombotic syndrome † 1   
# participants affected / at risk   1/1461 (0.07%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA




  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:

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 13, 2017
Last Update Posted: November 13, 2017