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: July 3, 2013
Last verified: May 2012
  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 Alzheimers 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: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Rosiglitazone XR
Experimental drug
Other Name: Rosiglitazone XR

  Eligibility

Ages Eligible for Study:   51 Years to 91 Years
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490568

  Hide Study Locations
Locations
Argentina
GSK Investigational Site
Córdoba, Córdova, Argentina, x5009bin
Australia, New South Wales
GSK Investigational Site
Hornsby, New South Wales, Australia, 2077
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
Australia, South Australia
GSK Investigational Site
Woodville, South Australia, Australia, 5011
Australia, Victoria
GSK Investigational Site
Heidelberg Heights, Victoria, Australia, 3084
Austria
GSK Investigational Site
Vienna, Austria, A-1220
GSK Investigational Site
Vienna, Austria, A-1130
Chile
GSK Investigational Site
Providencia / Santiago, Región Metro De Santiago, Chile, 7500710
GSK Investigational Site
Viña del Mar, Valparaíso, Chile, 252-0997
France
GSK Investigational Site
Bourg en Bresse, France, 01012
GSK Investigational Site
Caen, France, 14033
GSK Investigational Site
Dijon, France, 21000
GSK Investigational Site
Ivry, France, 94206
GSK Investigational Site
La Seyne sur Mer, France, 83500
GSK Investigational Site
Lille, France, 59000
GSK Investigational Site
Limoges, France, 87042
GSK Investigational Site
Luynes, France, 37230
GSK Investigational Site
Lyon, France, 69006
GSK Investigational Site
Marseille, France, 13009
GSK Investigational Site
Marseille, France, 13008
GSK Investigational Site
Metz, France, 57038
GSK Investigational Site
Nantes, France, 44000
GSK Investigational Site
Nantes, France, 44300
GSK Investigational Site
Nantes, France, 44093
GSK Investigational Site
Nantes, France, 44200
GSK Investigational Site
Nice, France, 06002
GSK Investigational Site
Paris, France, 75013
GSK Investigational Site
Pau, France, 64000
GSK Investigational Site
Rodez, France, 12000
GSK Investigational Site
Saint Ouen la Rouerie, France, 35460
GSK Investigational Site
Saint-Etienne, France, 42100
GSK Investigational Site
Sautron, France, 44880
GSK Investigational Site
Tinteniac, France, 35190
GSK Investigational Site
Toulon, France, 83000
GSK Investigational Site
Toulouse, France, 31300
GSK Investigational Site
Tours, France, 37100
GSK Investigational Site
Vichy, France, 03200
Greece
GSK Investigational Site
Athens, Greece, 115 21
GSK Investigational Site
Melissia, Greece, 151 27
Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 138-736
GSK Investigational Site
Seoul, Korea, Republic of, 150-713
Mexico
GSK Investigational Site
Monterrey, Nuevo León, Mexico, 64710
GSK Investigational Site
Monterrey, Nuevo León, Mexico, 64660
GSK Investigational Site
Mexico, Mexico, 14000
Netherlands
GSK Investigational Site
Hengelo, Netherlands, 7555 DL
Philippines
GSK Investigational Site
Pasig City, Philippines, 1600
Portugal
GSK Investigational Site
Coimbra, Portugal, 3000-548
GSK Investigational Site
Lisboa, Portugal, 1649-035
Slovenia
GSK Investigational Site
Ljubljana, Slovenia, 1000
GSK Investigational Site
Šempeter, Slovenia, 5290
Spain
GSK Investigational Site
Barcelona, Spain, 08003
GSK Investigational Site
Burgos, Spain, 09006
GSK Investigational Site
Castellón, Spain, 12004
GSK Investigational Site
Gerona, Spain, 17190
GSK Investigational Site
Murcia, Spain, 30120
GSK Investigational Site
Tarrasa, Barcelona, Spain, 08221
GSK Investigational Site
Valencia, Spain, 46010
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00490568     History of Changes
Other Study ID Numbers: AVA102675
Study First Received: June 21, 2007
Last Updated: July 3, 2013
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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Rosiglitazone
Dementia
Tauopathies
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Hypoglycemic Agents

ClinicalTrials.gov processed this record on April 22, 2014