Trial record 6 of 15 for:    Alzheimer rosiglitazone

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

June 21, 2007
July 3, 2013
August 2007
April 2009   (final data collection date for primary outcome measure)
Incidence and severity of Adverse Events. [ Time Frame: 52 weeks ]
Incidence and severity of Adverse Events over the course of 52 weeks. [ Time Frame: 52 Weeks ]
Complete list of historical versions of study NCT00490568 on ClinicalTrials.gov Archive Site
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 ]
ADAS-cog, CDR-SB, MMSE, DAD and NPI total scores as a function of APOE e4 status. Incidence and severity(52 weeks) of SAEs, percentage of subjects with edema, change from baseline in vital signs, weight, non-fasting measures of lipid metabolism. [ Time Frame: 52 Weeks ]
Not Provided
Not Provided
 
Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers
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).

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Alzheimer's Disease
Drug: Rosiglitazone XR
Experimental drug
Other Name: Rosiglitazone XR
Experimental: Arm 1
Intervention: Drug: Rosiglitazone XR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1480
April 2009
April 2009   (final data collection date for primary outcome measure)

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.
Both
51 Years to 91 Years
No
Contact information is only displayed when the study is recruiting subjects
France,   Australia,   Austria,   Chile,   Spain,   Greece,   Korea, Republic of,   Mexico,   Netherlands,   Philippines,   Portugal,   Slovenia,   Argentina
 
NCT00490568
AVA102675
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP