Trial record 5 of 15 for:    Alzheimer rosiglitazone

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00381238
First received: September 26, 2006
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: rosiglitazone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Long term safety and tolerability of rosiglitazone (RSG) XR. [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Long-term efficacy of RSG XR in terms of orientation, memory (recent and immediate), concentration, language and praxis. [ Time Frame: one year ]
  • Frequency of serious adverse events. [ Time Frame: one year ]
  • Percentage of subjects with adverse event of edema [ Time Frame: one year ]
  • Change from baseline in vital signs. Frequency of vital signs of clinical concern. [ Time Frame: one year ]
  • Change from baseline in weight. [ Time Frame: one year ]
  • Frequency of clinical chemistry (including lipids) and hematology parameters of clinical concern. [ Time Frame: one year ]

Enrollment: 33
Study Start Date: June 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rosiglitazone
Extended Release Tablets
Drug: rosiglitazone
Extended Release Tablets

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00381238

Locations
United States, Arizona
GSK Investigational Site
Litchfield Park, Arizona, United States, 85340
GSK Investigational Site
Phoenix, Arizona, United States, 85006
GSK Investigational Site
Sun City, Arizona, United States, 85351
United States, Massachusetts
GSK Investigational Site
Belmont, Massachusetts, United States, 02478
United States, Michigan
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109
United States, North Carolina
GSK Investigational Site
Durham, North Carolina, United States, 27705
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H4H 1R3
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00381238     History of Changes
Other Study ID Numbers: AVA104617
Study First Received: September 26, 2006
Last Updated: November 21, 2013
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Alzheimer's Disease
Rosiglitazone

Additional relevant MeSH terms:
Alzheimer Disease
Rosiglitazone
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014