Clinical trial NCT00381238: Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease
Official title: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
Rosiglitazone
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-09-27
Enrollment: 33
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AE's)
timeFrame: From start of study medication (Wk 0) to Wk 50
Secondary outcomes:
measure: Mean Change From Baseline in Mini Mental State Examination (MMSE) Total Score
timeFrame: From baseline to Wk 48
measure: Number of Participants With SAEs
timeFrame: From start of study medication (Wk 0) to Wk 50
measure: Number of Participants With AE of Peripheral Edema by Grade
timeFrame: Up to Wk 50
measure: Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure
timeFrame: Baseline (Wk 0) to Wk 50
measure: Mean Change From Baseline in Vital Signs-heart Rate (HR)
timeFrame: Baseline (Wk 0) to Wk 50
measure: Number of Participants With Vital Signs of Clinical Concern.
timeFrame: Up to Wk 50
measure: Mean Change From Baseline in Vital Signs- Weight
timeFrame: Baseline (Wk 0) to Wk 50
measure: Number of Participants With Clinical Chemistry Parameters of Clinical Concern
timeFrame: Up to Wk 50
measure: Number of Participants With Clinical Chemistry Parameters of Clinical Concern-lipids
timeFrame: Up to Wk 50
measure: Number of Participant's With Hematology Parameters of Clinical Concern
timeFrame: Up to Wk 50
Other outcomes:
Locations:
city: Litchfield Park
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Sun City
country: United States
facility: GSK Investigational Site
state: Arizona
city: Belmont
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: GSK Investigational Site
state: Michigan
city: Durham
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: This study has not been published in the scientific literature.