An open-label extension to study AVA100193, to assess the long-term safety and efficacy of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's disease.
- Conditions
- Mild to moderate Alzheimer's Disease
- Registration Number
- EUCTR2004-000985-12-HU
- Lead Sponsor
- GlaxoSmithKline R&D Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
A subject will be eligible for inclusion in the study only if all the following criteria apply:
1.Male or female subject who has successfully completed Visit 8 of AVA100193 (24 weeks of treatment) without tolerability issues, where in the opinion of the subject and of the investigator, it will be beneficial to continue treatment with RSG XR .
2.Female subjects must be post-menopausal (i.e. >6 months without menstrual period), surgically sterile, or if of child-bearing potential, using effective contraceptive measures (oral contraceptives, Norplant®, Depo-Provera®, an intra-uterine device (IUD) a diaphragm with spermicide or a condom with spermicide). Women of childbearing potential must use effective contraceptive measures throughout the study and for 30 days after discontinuing study medication. The subject and their caregiver must ensure that the subject will continuously use contraceptive measures throughout the duration of the study.
3.Subject is willing to participate in the extention study and has provided full written informed consent prior to the performance of any protocol-specified procedure; or if unable to provide informed consent due to cognitive status, full written informed consent on behalf of the subject has been provided by a legally acceptable representative .
4.Caregiver has provided full written informed consent on his or her own behalf prior to the performance of any protocol-specified procedure
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
;
A subject will be eligible for inclusion in the study only if all the following criteria apply:
1.Male or female subject who has successfully completed Visit 8 of AVA100193 (24 weeks of treatment) without tolerability issues, where in the opinion of the subject and of the investigator, it will be beneficial to continue treatment with RSG XR .
2.Female subjects must be post-menopausal (i.e. >6 months without menstrual period), surgically sterile, or if of child-bearing potential, using effective contraceptive measures (oral contraceptives, Norplant®, Depo-Provera®, an intra-uterine device (IUD) a diaphragm with spermicide or a condom with spermicide). Women of childbearing potential must use effective contraceptive measures throughout the study and for 30 days after discontinuing study medication. The subject and their caregiver must ensure that the subject will continuously use contraceptive measures throughout the duration of the study.
3.Subject is willing to participate in the extention study and has provided full written informed consent prior to the performance of any protocol-specified procedure; or if unable to provide informed consent due to cognitive status, full written informed consent on behalf of the subject has been provided by a legally acceptable representative .
4.Caregiver has provided full written informed consent on his or her own behalf prior to the performance of any protocol-specified procedure
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
1.Subject had a serious adverse experience or clinically significant laboratory abnormality during AVA100193, which in the opinion of the investigator could have been attributable to study medication, and which is ongoing at the end of AVA100193.
2.The subject is felt by the investigator to be unsuitable (on the basis of health, compliance, caregiver availability, or for any other reason) for inclusion in the study.
3.The subject experienced a significant cardiovascular event during AVA100193 (e.g. intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome [non Q-wave myocardial infarction, Q-wave myocardial infarction, unstable angina] or significant arrhythmia), unless a thorough cardiovascular evaluation has been performed which confirms that the subject does not have congestive heart failure, and is clinically stable.
4.Treatment with a cholinesterase inhibitor, selegiline, memantine or any other treatment for cognitive symptoms/AD (including but not limited to papaverin, cinnarisin, cerebrolysin) is initiated at the end of AVA100193.
;
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
1.Subject had a serious adverse experience or clinically significant laboratory abnormality during AVA100193, which in the opinion of the investigator could have been attributable to study medication, and which is ongoing at the end of AVA100193.
2.The subject is felt by the investigator to be unsuitable (on the basis of health, compliance, caregiver availability, or for any other reason) for inclusion in the study.
3.The subject experienced a significant cardiovascular event during AVA100193 (e.g. intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome [non Q-wave myocardial infarction, Q-wave myocardial infarction, unstable angina] or significant arrhythmia), unless a thorough cardiovascular evaluation has been performed which confirms that the subject does not have congestive heart failure, and is clinically stable.
4.Treatment with a cholinesterase inhibitor, selegiline, memantine or any other treatment for cognitive symptoms/AD (including but not limited to papaverin, cinnarisin, cerebrolysin) is initiated at the end of AVA100193.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of this study is to evaluate the long-term safety and tolerability of RSG XR in subjects with mild to moderate Alzheimer's disease who have completed 24 weeks of treatment in the AVA100193 study.;Secondary Objective: The secondary objective of this study is to evaluate further the long-term efficacy of RSG XR in terms of cognitive function, overall clinical response, measures of behaviour and activities of daily living;Primary end point(s): 1.Frequency of adverse events.;Main Objective: The main objective of this study is to evaluate the long-term safety and tolerability of RSG XR in subjects with mild to moderate Alzheimer's disease who have completed 24 weeks of treatment in the AVA100193 study.;Secondary Objective: The secondary objective of this study is to evaluate further the long-term efficacy of RSG XR in terms of cognitive function, overall clinical response, measures of behaviour and activities of daily living;Primary end point(s): 1.Frequency of adverse events.
- Secondary Outcome Measures
Name Time Method