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Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers

This study has been terminated.
(Based on preliminary parent study results)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00490568
First received: June 21, 2007
Last updated: September 28, 2016
Last verified: September 2016
  Purpose
This is a Phase III, multicenter, open-label extension, single-group study in male and female outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed either AVA102670 or AVA102672. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg once daily for the first 4 weeks of the study followed by 8mg RSG XR as adjunctive therapy to their existing dose of acetylcholinesterase inhibitor. Subject participation will last until one of 5 conditions applies. After a 52-week open-label treatment phase, subjects will attend a final Follow-Up Visit 6 weeks after the end of treatment. The primary objective of this study is to evaluate the long-term safety and tolerability of RSG XR in subjects with mild-to-moderate AD who have completed either AVA102670 or AVA102672. The secondary objective of this study is to explore further the long-term efficacy of RSG XR in terms of cognitive function and overall clinical response as a function of apolipoprotein E (APOE) e4 allele status.

Condition Intervention Phase
Alzheimer's Disease
Drug: Rosiglitazone XR
Phase 3

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 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).

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Incidence and severity of Adverse Events. [ Time Frame: 52 weeks ]

Secondary Outcome Measures:
  • ADAS-cog, CDR-SB, MMSE, DAD and NPI total scores as a function of APOE e4 status. Incidence and severity of SAEs, percentage of subjects with edema, change from baseline in vital signs, weight, non-fasting measures of lipid metabolism. [ Time Frame: 52 weeks ]

Enrollment: 1480
Study Start Date: August 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rosiglitazone XR
Investigational drug
Drug: Rosiglitazone XR
Experimental drug

  Eligibility

Ages Eligible for Study:   51 Years to 91 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Successful completion of AVA102670 or AVA102672 without safety or tolerability issues. Regular caregiver.

Exclusion criteria:

  • Congestive Heart Failure (NYHA 1-4), clinically significant peripheral edema, other neurological conditions that might disqualify participation. SAE, clinically significant laboratory abnormality or significant cardiovascular event during prior study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490568

  Show 272 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: AVA102675
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: AVA102675
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: AVA102675
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: AVA102675
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: AVA102675
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: AVA102675
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: AVA102675
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00490568     History of Changes
Other Study ID Numbers: AVA102675 
Study First Received: June 21, 2007
Last Updated: September 28, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
cognition
Alzheimer's disease
Rosiglitazone extended-release (XR)
safety
adjunctive therapy
BRL-049653
tolerability
open-label extension

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Rosiglitazone
Dementia
Tauopathies
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Hypoglycemic Agents

ClinicalTrials.gov processed this record on December 09, 2016