Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease

GlaxoSmithKline33 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alzheimer's Disease

Interventions

rosiglitazoneDRUG

Extended Release Tablets

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (7)

GSK Investigational Site

Litchfield Park, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Sun City, Arizona, United States

GSK Investigational Site

Belmont, Massachusetts, United States

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AE's)

An AE was defined as any untoward medical occurrence or clinical investigation in a participant, temporally associated with the use of a medicinal product, whether or not, considered related to the medicinal product. For marketed medicinal products, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The number of participants with all AEs, drug related AEs, serious adverse events (SAEs), AE leading to permanent (prm) discontinuation (disc) of study drug or withdrawal were reported.

Time frame: From start of study medication (Wk 0) to Wk 50

Secondary Outcomes

Mean Change From Baseline in Mini Mental State Examination (MMSE) Total Score

The MMSE, is a score scale which consists of 11 tests of orientation (to time and place), memory (recent and immediate), concentration, language and praxis. The scoring ranged from 0 to 30, with lower scores indicative of greater cognitive impairment (more severe disease) and higher scores indicative less cognitive impairment (less severe disease). The total score was calculated by summing the scores from each of the tests. The investigator questioned the participants individually with set of questions and scored the participant, based on his performance. The baseline was defined as Wk 0. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values.

Time frame: From baseline to Wk 48

Number of Participants With SAEs

An SAE, is any untoward medical occurrence, that at any dose may result in death, is life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability or incapacity, is congenital anomaly or birth defect, and medically important events. The number of participants with any SAE, were reported.

Time frame: From start of study medication (Wk 0) to Wk 50

Number of Participants With AE of Peripheral Edema by Grade

Participants with AE of peripheral edema were evaluated. The test was performed by firmly pressing the thumb anterior to the participants ankle until further pressure produced no greater indentation. The depth of the pit was estimated and it was graded using below 5 point scale; where estimated depth of indentation corresponded to a particular grade (G). G 0 as depth of \<1 millimeter (mm); G1 as depth of 1-2 mm; G2 as depth of 3-5 mm; G3 as depth of 6-10 mm; and G4 as depth of \> 10 mm. The data for only the participants who had peripheral edema on more than one visit, then their most severe G were presented.

Data from ClinicalTrials.gov

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