Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: rosiglitazone
Intervention description: Extended Release Tablets
Intervention MeSH terms: Rosiglitazone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Alzheimer's Disease; Rosiglitazone

Summary:

      This is an open-label extension to study 49653/461, to assess the long-term safety of
      rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's
      Disease.
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or female subject who has successfully completed the 12 Month Visit of 49653/461
             (12 months 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.

          -  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.

          -  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[1].[1] Where this is in accordance with local laws, regulations and
             ethics committee policy.

          -  Caregiver has provided full written informed consent on his or her own behalf prior to
             the performance of any protocol-specified procedure.

        Exclusion criteria:

          -  Subject had a serious adverse experience (SAE) or clinically significant laboratory
             abnormality during 49653/461, which in the opinion of the investigator could have been
             attributable to study medication, and which is ongoing at the end of 49653/461.

          -  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 based on the entry criteria for the primary study, 49653/461 (exclusive of the
             age criteria which may not be applicable to some of the subjects).

          -  The subject experienced a significant cardiovascular event during 49653/461 (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.

          -  Treatment with a cholinesterase inhibitor, selegiline, memantine or any other
             treatment for cognitive symptoms/AD is initiated at the end of 49653/461.