A 52-week open-label extension study of the long-term safety and efficacy of rosiglitazone extended-release (RSG XR) as adjunctive therapy to acetylcholinesterase inhibitors in subjects with mild-to-moderate Alzheimer's disease (REFLECT-4).
- Conditions
- Alzheimer’s disease,MedDRA version: 9.1Level: LLTClassification code 10001896Term: Alzheimer's disease
- Registration Number
- EUCTR2006-004152-20-GB
- Lead Sponsor
- GlaxoSmithKline Research & Development Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1500
Subjects eligible for enrollment in the study must meet all of the following criteria:
1. Male or female subject who has successfully completed Visit 10 of AVA102670 or
AVA102672 without safety/tolerability issues, where in the opinion of the
subject/carer and of the investigator, it would be beneficial to receive RSG XR.
However subjects who have completed of the double-blind treatment phase may still
be eligible for entry if they withdraw during the last 6 weeks of AVA102670 or
AVA102672 due to any reason other than safety (subjects who withdraw from
AVA102670 or AVA102672 due to safety/tolerability issues during the last 6 weeks
of treatment will not be eligible to enter this study).
2. Female subjects able to bear children must agree to use an adequate method of
contraception for the duration of the study (See Appendix 11.1 for details of highly
effective methods to avoid pregnancy). Female subjects who are pre-menopausal or
who have been post-menopausal for <1 year must undertake pregnancy testing (urine test) =7 days before Visit 1, which must be negative1.
3. Subject is willing to participate in the extension 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 (where this is in accordance with local laws, regulations and ethics
committee policy).
4. Subject lives with (or has substantial periods of contact with) a regular caregiver who is willing to attend all visits, oversee the subject's compliance with protocol-specified procedures and study medication, and report on subject's status2.
5. Subject has the ability to comply with procedures for cognitive and other testing.
6. Caregiver has provided full written informed consent on his or her own behalf prior
to the performance of any protocol-specified procedure.
7. Subjects considered for enrolment must have a QTc (either QTc B (Bazett's
correction) or QTc F (Fridericia's correction)) <450msec at Visit 1, with the
exception of subjects with bundle branch block (for whom either QTc B or QTc F
must be <480msec)3.
8. In France, a subject will be eligible for inclusion in this study only if either affiliated
to or a beneficiary of a social security category.
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
;
Subjects eligible for enrollment in the study must meet all of the following criteria:
1. Male or female subject who has successfully completed Visit 10 of AVA102670 or
AVA102672 without safety/tolerability issues, where in the opinion of the
subject/carer and of the investigator, it would be beneficial to receive RSG XR.
However subjects who have completed of the double-blind treatment phase may still
be eligible for entry if they withdraw during the last 6 weeks of AVA102670 or
AVA102672 due to any reason other than safety (subjects who withdraw from
AVA102670 or AVA102672 due to safety/tolerability issues during the last 6 weeks
of treatment will not be eligible to enter this study).
2. Female subjects able to bear children must agree to use an adequate method of
contraception for the duration of the study (See Appendix 11.1 for details of highly
effective methods to avoid pregnancy). Female subjects who are pre-menopausal or
who have been post-menopausal for <1 year must undertake pregnancy testing (urine test) =7 days before Visit 1, which must be negative1.
3. Subject is willing to participate in the extension 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 (where this is in accordance with local laws, regulations and ethics
committee policy).
4. Subject lives with (or has substantial periods of contact with) a regular caregiver who is willing to attend all visits, oversee the subject's compliance with protocol-specified procedures and study medication, and report on subject's status2.
5. Subject has the ability to comply with procedures for cognitive and other testing.
6. Caregiver has provided full written informed consent on his or her own behalf prior
to the performance of any protocol-specified procedure.
7. Subjects considered for enrolment must have a QTc (either QTc B (Bazett's
correction) or QTc F (Fridericia's correction)) <450msec at Visit 1, with the
exception of subjects with bundle branch block (for whom either QTc B or QTc F
must be <480msec)3.
8. In France, a subject will be eligible for inclusion in this study only if either affiliated
to or a beneficiary of a social security category.
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
Subjects meeting any of the following criteria must not be enrolled in the study:
1. Subject had a serious adverse experience or clinically significant laboratory
abnormality during AVA102670 or AVA102672, which in the opinion of the
investigator could have been attributable to study medication, and which is ongoing
at Visit 1.
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 AVA102670 or
AVA102672 (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. Clinical/investigational evidence of congestive heart failure defined by the New
York Heart Association (NYHA) criteria (Class I to IV cardiac status) at the time of
Visit 1.
5. Clinically significant peripheral oedema at the time of Visit 1.
6. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline
phosphatase values >2.5 times the ULN, total bilirubin values >1.5 times the upper
limit of normal (ULN), or history of severe hepatobiliary disease (e.g. hepatitis B or
C, or cirrhosis, Child-Pugh Class B/C).
In Canada only, the following change will be made to Exclusion Criteria number 6.
ALT, AST, or alkaline phosphatase values >2.0 times the ULN, total bilirubin values
>1.5 times the ULN, or history of severe hepatobiliary disease (e.g. hepatitis B or C,
or cirrhosis, Child-Pugh Class B/C).
7. Subject is an immediate family member or employee of the participating
Investigator, of any of the participating site staff, or of GSK.
8. In France, a subject is neither affiliated with nor a beneficiary of a social security
category.
9. In France, a subject has participated in any study using an investigational drug
during the previous 30 days (except for participation in AVA102670 or
AVA102672).
;
Subjects meeting any of the following criteria must not be enrolled in the study:
1. Subject had a serious adverse experience or clinically significant laboratory
abnormality during AVA102670 or AVA102672, which in the opinion of the
investigator could have been attributable to study medication, and which is ongoing
at Visit 1.
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 AVA102670 or
AVA102672 (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. Clinical/investigational evidence of congestive heart failure defined by the New
York Heart Association (NYHA) criteria (Class I to IV cardiac status) at the time of
Visit 1.
5. Clinically significant peripheral oedema at the time of Visit 1.
6. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline
phosphatase values >2.5 times the ULN, total bilirubin values >1.5 times the upper
limit of normal (ULN), or history of severe hepatobiliary disease (e.g. hepatitis B or
C, or cirrhosis, Child-Pugh Class B/C).
In Canada only, the following change will be made to Exclusion Criteria number 6.
ALT, AST, or alkaline phosphatase values >2.0 times the ULN, total bilirubin values
>1.5 times the ULN, or history of severe hepatobiliary disease (e.g. hepatitis B or C,
or cirrhosis, Child-Pugh Class B/C).
7. Subject is an immediate family member or employee of the participating
Investigator, of any of the participating site staff, or of GSK.
8. In France, a subject is neither affiliated with nor a beneficiary of a social security
category.
9. In France, a subject has participated in any study using an investigational drug
during the previous 30 days (except for participation in AVA102670 or
AVA102672).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method