Last updated: 11/04/2018 05:14:06
Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers
EudraCT ID
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: An open-label extension to study AVA102670 and AVA102672, to assess the long-term safety and efficacy of rosiglitazone (extended release tablets) as adjunctive therapy on cognition in subjects with mild to moderate Alzheimer's disease.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of participants with any adverse events (AEs) and severity of AEs
Timeframe: Up to 76 Weeks
Secondary outcomes:
Number participants with serious adverse events (SAEs) and deaths
Timeframe: Up to 76 Weeks
Number of participants with adverse event of oedema
Timeframe: Up to 76 Weeks
Change from Baseline in vital sign systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Timeframe: Up to 70 Weeks (including follow up)
Change from Baseline in vital sign heart rate (HR)
Timeframe: Up to 70 Weeks (including follow up)
Change from Baseline in vital sign body weight (BW)
Timeframe: Up to 70 Weeks (including follow up)
Change from Baseline in non-fasting measures of lipid metabolism namely total cholesterol (TC), high density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides
Timeframe: Up to 82 Weeks (including follow up)
Number of participants with SBP and DBP values of potential clinical concern (PCC)
Timeframe: Up to 70 Weeks (including follow up)
Number of participants with HR values of PCC ATOT
Timeframe: Up to 70 Weeks (including follow up)
Number of participants with BW values of PCC ATOT
Timeframe: Up to 70 Weeks (including follow up)
Number of participants with hematology parameters of PCC ATOT
Timeframe: Up to Week 82 (including follow up)
Number of participants with clinical chemistry parameters (including lipids) of PCC ATOT
Timeframe: Up to Week 82 (including follow up)
Change from Baseline in Alzheimer's Disease Assessment Scale – cognitive (ADAS-cog) total score as a function of apolipoprotein E (APOE) ε4 status.
Timeframe: Baseline (Week 0) and Week 24, 52
Change from Baseline in Clinical Dementia Rating scale–Sum of Boxes (CDR-SB) score as a function of APOE ε4 status.
Timeframe: Baseline (Week 0) and Week 24, 52
Change from Baseline in Mini Mental State Examination (MMSE) total score as a function of APOE ε4 status.
Timeframe: Baseline (Week 0) and Week 24, 52
Change from Baseline in Disability Assessment for Dementia scale (DAD) total score as a function of APOE ε4 status.
Timeframe: Baseline (Week 0) and Week 24, 52
Change from Baseline in Neuropsychiatric Inventory (NPI) total score as a function of APOE ε4 status.
Timeframe: Baseline (Week 0) and Week 24, 52
Interventions:
Enrollment:
1461
Primary completion date:
2009-30-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Conn Harrington, Sharon Sawchak, Carl Chiang, John Davies, Carly Donovan, Ann Saunders, Michael Irrizary, Barbara Jeter, Marina Zvartau-Hind, Christopher van Dyke, Michael Gold. Rosiglitazone does not improve cognition or global function when used as adjunctive therapy to AChE inhibitors in mild-to-moderate Alzheimer's disease: Two phase 3 studies. Curr Alzheimer Res. 2011;8(5):592-584.
Medical condition
Alzheimer's Disease
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
August 2007 to May 2009
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
51 - 91 years
Accepts healthy volunteers
No
- Successful completion of AVA102670 or AVA102672 without safety or tolerability issues. Regular caregiver.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Juelich, Nordrhein-Westfalen, Germany, 52428
Status
Study Complete
Location
GSK Investigational Site
Greenfield Park, Québec, Canada, J4V 2J2
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10016
Status
Study Complete
Showing 1 - 6 of 268 Results
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Other
Actual primary completion date
2009-30-05
Actual study completion date
2009-30-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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