AzTrials
AzTrials

Alzheimer's DiseasePhase 3NCT00490568

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

A Phase 3 study testing Rosiglitazone XR in people with Alzheimer's Disease, run by GlaxoSmithKline at 272 sites in 29 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 51 to 91 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
Rosiglitazone XR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,461 participants
Where
272 sitesin 29 countries
Study dates
8 Aug 2007to 1 Jun 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 51 to 91 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

272 sites in 29 countries.

272 sites in 29 countries

Germany55 sites

  • GSK Investigational Site

    Aalen, Baden-Wurttemberg, 73430

  • GSK Investigational Site

    Achim, Lower Saxony, 28832

  • GSK Investigational Site

    Alzenau in Unterfranken, Bavaria, 63755

  • GSK Investigational Site

    Bad Homburg, Hesse, 61348

  • GSK Investigational Site

    Bad Honnef, North Rhine-Westphalia, 53604

  • GSK Investigational Site

    Bad Saarow, Brandenburg, 15526

  • GSK Investigational Site

    Baesweiler, North Rhine-Westphalia, 52499

  • GSK Investigational Site

    Bergisch Gladbach, North Rhine-Westphalia, 51465

  • GSK Investigational Site

    Berlin, 12163

  • GSK Investigational Site

    Berlin, 12167

  • GSK Investigational Site

    Berlin, 12555

  • GSK Investigational Site

    Berlin, 13156

  • GSK Investigational Site

    Berlin, 13357

  • GSK Investigational Site

    Berlin, 13439

  • GSK Investigational Site

    Bochum, North Rhine-Westphalia, 44791

  • GSK Investigational Site

    Bochum, North Rhine-Westphalia, 44805

  • GSK Investigational Site

    Bochum, North Rhine-Westphalia, 44869

  • GSK Investigational Site

    Bockhorn, Lower Saxony, 26345

  • GSK Investigational Site

    Chemnitz, Saxony, 09111

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 50767

  • GSK Investigational Site

    Dresden, Saxony, 01097

  • GSK Investigational Site

    Dresden, Saxony, 01307

  • GSK Investigational Site

    Duisburg, North Rhine-Westphalia, 47051

  • GSK Investigational Site

    Düren, North Rhine-Westphalia, 52349

  • GSK Investigational Site

    Ellwangen, Baden-Wurttemberg, 73479

  • GSK Investigational Site

    Erbach im Odenwald, Hesse, 64711

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45138

  • GSK Investigational Site

    Ganderkesee, Lower Saxony, 27777

  • GSK Investigational Site

    Gera, Thuringia, 07551

  • GSK Investigational Site

    Göttingen, Lower Saxony, 37075

  • GSK Investigational Site

    Hamburg, 21149

  • GSK Investigational Site

    Hamburg, 22083

  • GSK Investigational Site

    Hanover, Lower Saxony, 30559

  • GSK Investigational Site

    Hattingen, North Rhine-Westphalia, 45525

  • GSK Investigational Site

    Jena, Thuringia, 07743

  • GSK Investigational Site

    Jülich, North Rhine-Westphalia, 52428

  • GSK Investigational Site

    Krefeld, North Rhine-Westphalia, 47800

  • GSK Investigational Site

    Leipzig, Saxony, 04107

  • GSK Investigational Site

    Leipzig, Saxony, 04157

  • GSK Investigational Site

    Ludwigsburg, Baden-Wurttemberg, 71634

  • GSK Investigational Site

    Lüneburg, Lower Saxony, 21335

  • GSK Investigational Site

    Munich, Bavaria, 80331

  • GSK Investigational Site

    Munich, Bavaria, 80333

  • GSK Investigational Site

    Munich, Bavaria, 81667

  • GSK Investigational Site

    Munich, Bavaria, 81675

  • GSK Investigational Site

    Nuremberg, Bavaria, 90402

  • GSK Investigational Site

    Ostfildern, Baden-Wurttemberg, 73760

  • GSK Investigational Site

    Regensburg, Bavaria, 93053

  • GSK Investigational Site

    Schwerin, Mecklenburg-Vorpommern, 19053

  • GSK Investigational Site

    Siegen, North Rhine-Westphalia, 57072

  • GSK Investigational Site

    Stuttgart, Baden-Wurttemberg, 70176

  • GSK Investigational Site

    Tübingen, Baden-Wurttemberg, 72076

  • GSK Investigational Site

    Ulm, Baden-Wurttemberg, 89075

  • GSK Investigational Site

    Unterhaching, Bavaria, 82008

  • GSK Investigational Site

    Westerstede, Lower Saxony, 26655

Other trials in Germany

United States41 sites

  • GSK Investigational Site

    Albany, New York, 12205

  • GSK Investigational Site

    Austin, Texas, 78757

  • GSK Investigational Site

    Bennington, Vermont, 05201

  • GSK Investigational Site

    Brooklyn, New York, 11235

  • GSK Investigational Site

    Columbus, Ohio, 43210

  • GSK Investigational Site

    Deerfield Beach, Florida, 33064

  • GSK Investigational Site

    Delray Beach, Florida, 33445

  • GSK Investigational Site

    Fort Wayne, Indiana, 46805

  • GSK Investigational Site

    Fresno, California, 93720

  • GSK Investigational Site

    Hialeah, Florida, 33016

  • GSK Investigational Site

    Litchfield Park, Arizona, 85340

  • GSK Investigational Site

    Little Rock, Arkansas, 72205

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53226

  • GSK Investigational Site

    Morristown, New Jersey, 07960

  • GSK Investigational Site

    New Haven, Connecticut, 06510

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    Norwalk, Connecticut, 06851

  • GSK Investigational Site

    Ocala, Florida, 34471

  • GSK Investigational Site

    Phoenix, Arizona, 85013

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15213

  • GSK Investigational Site

    Providence, Rhode Island, 02906

  • GSK Investigational Site

    Raleigh, North Carolina, 27607

  • GSK Investigational Site

    Rancho Mirage, California, 92270

  • GSK Investigational Site

    Rockville, Maryland, 20852

  • GSK Investigational Site

    Sacramento, California, 95816

  • GSK Investigational Site

    Saint Paul, Minnesota, 55101

  • GSK Investigational Site

    San Diego, California, 92103

  • GSK Investigational Site

    San Francisco, California, 94109

  • GSK Investigational Site

    Sherman Oaks, California, 91403

  • GSK Investigational Site

    South Ogden, Utah, 84403

  • GSK Investigational Site

    Springfield, Massachusetts, 01104

  • GSK Investigational Site

    St. Petersburg, Florida, 33702

  • GSK Investigational Site

    Stratford, New Jersey, 08084

  • GSK Investigational Site

    Syracuse, New York, 13210

  • GSK Investigational Site

    Toledo, Ohio, 43623

  • GSK Investigational Site

    Toms River, New Jersey, 08755

  • GSK Investigational Site

    Tucson, Arizona, 85741

  • GSK Investigational Site

    Tulsa, Oklahoma, 74104

  • GSK Investigational Site

    West Palm Beach, Florida, 33407

  • GSK Investigational Site

    West Yarmouth, Massachusetts, 02673

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

France28 sites

  • GSK Investigational Site

    Bourg-en-Bresse, 01012

  • GSK Investigational Site

    Caen, 14033

  • GSK Investigational Site

    Dijon, 21000

  • GSK Investigational Site

    Ivry, 94206

  • GSK Investigational Site

    La Seyne-sur-Mer, 83500

  • GSK Investigational Site

    Lille, 59000

  • GSK Investigational Site

    Limoges, 87042

  • GSK Investigational Site

    Luynes, 37230

  • GSK Investigational Site

    Lyon, 69006

  • GSK Investigational Site

    Marseille, 13008

  • GSK Investigational Site

    Marseille, 13009

  • GSK Investigational Site

    Metz, 57038

  • GSK Investigational Site

    Nantes, 44000

  • GSK Investigational Site

    Nantes, 44093

  • GSK Investigational Site

    Nantes, 44200

  • GSK Investigational Site

    Nantes, 44300

  • GSK Investigational Site

    Nice, 06002

  • GSK Investigational Site

    Paris, 75013

  • GSK Investigational Site

    Pau, 64000

  • GSK Investigational Site

    Rodez, 12000

  • GSK Investigational Site

    Saint-Etienne, 42100

  • GSK Investigational Site

    Saint-Ouen-la-Rouërie, 35460

  • GSK Investigational Site

    Sautron, 44880

  • GSK Investigational Site

    Tinténiac, 35190

  • GSK Investigational Site

    Toulon, 83000

  • GSK Investigational Site

    Toulouse, 31300

  • GSK Investigational Site

    Tours, 37100

  • GSK Investigational Site

    Vichy, 03200

Other trials in France

Canada19 sites

  • GSK Investigational Site

    Charlottetown, Prince Edward Island, C1A 5Y8

  • GSK Investigational Site

    Greenfield Park, Quebec, J4V 2J2

  • GSK Investigational Site

    Kentville, Nova Scotia, B4N 4K9

  • GSK Investigational Site

    Kingston, Ontario, K7L 4X3

  • GSK Investigational Site

    Kingston, Ontario, K7L 5G2

  • GSK Investigational Site

    Montreal, Quebec, H1T 2M4

  • GSK Investigational Site

    Montreal, Quebec, H4H 1R3

  • GSK Investigational Site

    Ottawa, Ontario, K1G 4G3

  • GSK Investigational Site

    Ottawa, Ontario, K1N 5C8

  • GSK Investigational Site

    Peterborough, Ontario, K9H 2P4

  • GSK Investigational Site

    Québec, G1R 3X5

  • GSK Investigational Site

    Regina, Saskatchewan, S4T 1A5

  • GSK Investigational Site

    Saint John, New Brunswick, E2L 3L6

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 1Z1

  • GSK Investigational Site

    Sherbrooke, Quebec, J1J 3H5

  • GSK Investigational Site

    Toronto, Ontario, M3B 2S7

  • GSK Investigational Site

    Toronto, Ontario, M5T 2S8

  • GSK Investigational Site

    Toronto, Ontario, M6M 3Z5

  • GSK Investigational Site

    Whitby, Ontario, L1N 5S9

Other trials in Canada

Italy15 sites

  • GSK Investigational Site

    Arezzo, Tuscany, 52100

  • GSK Investigational Site

    Brescia, Lombardy, 25125

  • GSK Investigational Site

    Chieti Scalo, Abruzzo, 66013

  • GSK Investigational Site

    Florence, Tuscany, 50134

  • GSK Investigational Site

    Milan, Lombardy, 20122

  • GSK Investigational Site

    Milan, Lombardy, 20127

  • GSK Investigational Site

    Naples, Campania, 80131

  • GSK Investigational Site

    Pavia, Lombardy, 27100

  • GSK Investigational Site

    Pisa, Tuscany, 56126

  • GSK Investigational Site

    Rho, Lombardy, 20017

  • GSK Investigational Site

    Rome, Lazio, 00148

  • GSK Investigational Site

    Rome, Lazio, 00163

  • GSK Investigational Site

    Rome, Lazio, 00186

  • GSK Investigational Site

    San Felice A Cancello Caserta, Campania, 81027

  • GSK Investigational Site

    Torrette (AN), The Marches, 60020

Other trials in Italy

Spain13 sites

  • GSK Investigational Site

    Barcelona, 08003

  • GSK Investigational Site

    Barcelona, 08014

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Barcelona, 08907

  • GSK Investigational Site

    Burgos, 09006

  • GSK Investigational Site

    Castellon, 12004

  • GSK Investigational Site

    Elche (Alicante), 03202

  • GSK Investigational Site

    Girona, 17190

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Murcia, 30120

  • GSK Investigational Site

    Palma de Mallorca, 07014

  • GSK Investigational Site

    Tarrasa, Barcelona, 08221

  • GSK Investigational Site

    Valencia, 46010

Other trials in Spain

Australia10 sites

  • GSK Investigational Site

    Auchenflower, Queensland, 4066

  • GSK Investigational Site

    Cheltenham, Victoria, 3192

  • GSK Investigational Site

    Chermside, Queensland, 4032

  • GSK Investigational Site

    Heidelberg Heights, Victoria, 3084

  • GSK Investigational Site

    Hornsby, New South Wales, 2077

  • GSK Investigational Site

    Kew, Victoria, 3101

  • GSK Investigational Site

    Kippa-Ring, Queensland, 4021

  • GSK Investigational Site

    Nedlands, Western Australia, 6009

  • GSK Investigational Site

    Randwick, New South Wales, 2031

  • GSK Investigational Site

    Woodville, South Australia, 5011

Other trials in Australia

Argentina9 sites

  • GSK Investigational Site

    Buenos Aires, C1425CDC

  • GSK Investigational Site

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1192AAW

  • GSK Investigational Site

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1419HDN

  • GSK Investigational Site

    Ciudad de Buenos Aires, Buenos Aires, C1431FWO

  • GSK Investigational Site

    Córdoba, Córdoba Province, 5000

  • GSK Investigational Site

    Córdoba, Córdoba Province, X5004AOA

  • GSK Investigational Site

    Córdoba, Córdoba Province, x5009bin

  • GSK Investigational Site

    Godoy Cruz, Mendoza Province, M5504FMI

  • GSK Investigational Site

    Mendoza, CPM5500HIF

Other trials in Argentina

Czechia8 sites

  • GSK Investigational Site

    Olomouc, 775 20

  • GSK Investigational Site

    Ostrava, 702 00

  • GSK Investigational Site

    Prague, 10000

  • GSK Investigational Site

    Prague, 120 00

  • GSK Investigational Site

    Prague, 150 18

  • GSK Investigational Site

    Prague, 170 00

  • GSK Investigational Site

    Prague, 180 00

  • GSK Investigational Site

    Trutnov, 541 01

Other trials in Czechia

Poland7 sites

  • GSK Investigational Site

    Bydgoszcz, 85-096

  • GSK Investigational Site

    Bydgoszcz, 85-796

  • GSK Investigational Site

    Katowice, 40-752

  • GSK Investigational Site

    Mosina, 62-050

  • GSK Investigational Site

    Poznan, 61-298

  • GSK Investigational Site

    Sopot, 81-824

  • GSK Investigational Site

    Warsaw, 02-097

Other trials in Poland

South Africa7 sites

  • GSK Investigational Site

    Loeventstein, 7530

  • GSK Investigational Site

    Oakdale, 7530

  • GSK Investigational Site

    Richards Bay, 3900

  • GSK Investigational Site

    Rosebank, 2196

  • GSK Investigational Site

    Somerset West, 7130

  • GSK Investigational Site

    Waverley, Bloemfontein, 9301

  • GSK Investigational Site

    Willows, X14, Pretoria, 0040

Other trials in South Africa

Netherlands6 sites

  • GSK Investigational Site

    's-Hertogenbosch, 5232 JL

  • GSK Investigational Site

    Alkmaar, 1815 JD

  • GSK Investigational Site

    Blaricum, 1261 AN

  • GSK Investigational Site

    Hengelo, 7555 DL

  • GSK Investigational Site

    Hilversum, 1213 XZ

  • GSK Investigational Site

    The Hague, 2545 CH

Other trials in Netherlands

Austria5 sites

  • GSK Investigational Site

    Hall in Tirol, A-6060

  • GSK Investigational Site

    Vienna, 1010

  • GSK Investigational Site

    Vienna, 1030

  • GSK Investigational Site

    Vienna, A-1130

  • GSK Investigational Site

    Vienna, A-1220

Other trials in Austria

India5 sites

  • GSK Investigational Site

    Hyderabad, 500 034

  • GSK Investigational Site

    Nagpur, 440010

  • GSK Investigational Site

    New Delhi, 110002

  • GSK Investigational Site

    Pune, 411004

  • GSK Investigational Site

    Varanasi, 221005

Other trials in India

Sweden5 sites

  • GSK Investigational Site

    Jönköping, SE-551 85

  • GSK Investigational Site

    Kalix, SE-952 82

  • GSK Investigational Site

    Mölndal, SE-431 41

  • GSK Investigational Site

    Sundsvall, SE-851 86

  • GSK Investigational Site

    Umeå, SE-901 85

Other trials in Sweden

Bulgaria4 sites

  • GSK Investigational Site

    Sofia, 1113

  • GSK Investigational Site

    Sofia, 1431

  • GSK Investigational Site

    Sofia, 1527

  • GSK Investigational Site

    Varna, 9010

Other trials in Bulgaria

Greece4 sites

  • GSK Investigational Site

    Athens, 115 21

  • GSK Investigational Site

    Athens, 151 23

  • GSK Investigational Site

    Melíssia, 151 27

  • GSK Investigational Site

    Thessaloniki, 57010

Other trials in Greece

Slovakia4 sites

  • GSK Investigational Site

    Bratislava, 811 01

  • GSK Investigational Site

    Bratislava, 811 07

  • GSK Investigational Site

    Bratislava, 825 56

  • GSK Investigational Site

    Košice, 041 66

Other trials in Slovakia

United Kingdom4 sites

  • GSK Investigational Site

    Blackpool, Lancashire, FY2 0JH

  • GSK Investigational Site

    Bradford, BD3 0DQ

  • GSK Investigational Site

    Liverpool, L9 7LJ

  • GSK Investigational Site

    West of Scotland Science Park, Glasgow, G20 0XA

Other trials in United Kingdom

Belgium3 sites

  • GSK Investigational Site

    Kortrijk, 8500

  • GSK Investigational Site

    Leuven, 3000

  • GSK Investigational Site

    Woluwe-Saint-Lambert, 1200

Other trials in Belgium

Chile3 sites

  • GSK Investigational Site

    Providencia / Santiago, Región Metro de Santiago, 7500710

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7560356

  • GSK Investigational Site

    Viña del Mar, Valparaiso, 252-0997

Other trials in Chile

Mexico3 sites

  • GSK Investigational Site

    México, 14000

  • GSK Investigational Site

    Monterrey, Nuevo León, 64660

  • GSK Investigational Site

    Monterrey, Nuevo León, 64710

Other trials in Mexico

South Korea3 sites

  • GSK Investigational Site

    Seongnam-si, 463-707

  • GSK Investigational Site

    Seoul, 138-736

  • GSK Investigational Site

    Seoul, 150-713

Other trials in South Korea

Finland2 sites

  • GSK Investigational Site

    Helsinki, 00120

  • GSK Investigational Site

    Kuopio, 70211

Other trials in Finland

Hong Kong2 sites

  • GSK Investigational Site

    Hong Kong

  • GSK Investigational Site

    Shatin

Other trials in Hong Kong

Hungary2 sites

  • GSK Investigational Site

    Győr, 9024

  • GSK Investigational Site

    Szeged, 6725

Other trials in Hungary

Portugal2 sites

  • GSK Investigational Site

    Coimbra, 3000-548

  • GSK Investigational Site

    Lisbon, 1649-035

Other trials in Portugal

Slovenia2 sites

  • GSK Investigational Site

    Ljubljana, 1000

  • GSK Investigational Site

    Šempeter v Savinjski Dolini, 5290

Other trials in Slovenia

Philippines1 site

  • GSK Investigational Site

    Pasig, 1600

Other trials in Philippines

About this study

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.

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.

Being tested
Rosiglitazone XR
Keywords
cognition, Alzheimer's disease, Rosiglitazone extended-release (XR), safety, adjunctive therapy, BRL-049653, tolerability, open-label extension
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rosiglitazone XRDrug

    Experimental drug

Study groups in NCT00490568
Study groupRoleWhat they receive
Rosiglitazone XRExperimentalInvestigational drug
Receives: Drug: Rosiglitazone XR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Any Adverse Events (AEs) and Severity of AEs

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The severity of the AE'S was categorized as mild, moderate and severe. Number of participants reporting AEs during the on treatment phase of the study.

    Measured: Up to 76 Weeks

Secondary outcomes (16)

  1. Number Participants With Serious Adverse Events (SAEs) and Deaths

    A SAE is defined as any untoward medical occurrence that, at any dose results in death, is a life-threatening condition, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or a congenital anomaly or birth defect. Number of participants with SAEs and deaths were reported for treatment duration of the study.

    Measured: Up to 76 Weeks

  2. Number of Participants With Adverse Event of Oedema

    Oedema was considered as adverse event of special interest (AESI). The process for AESI selection was based on RSG's pharmacologic class and relevant AEs potentially associated with RSG. The number of participants and their percentage for the adverse event of the various types of oedema were reported.

    Measured: Up to 76 Weeks

  3. Change From Baseline in Vital Sign Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

    Vital signs SBP and DBP were measured at each visit. All measurements were made on the participant non-dominant arm supported at heart level, using the same cuff size and same equipment. Blood pressure was measured once, after the participant sat quietly for at least 5 minutes. DBP was measured at the disappearance of Korotkoff sounds (Phase V). If the participant was a smoker or used tobacco products, a period of 30 minutes without tobacco was allowed before taking these measurements. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the blood pressure value recorded at specified visit minus the Baseline value.

    Measured: Up to 70 Weeks (including follow up)

  4. Change From Baseline in Vital Sign Heart Rate (HR)

    Vital sign HR was measured at each visit. HR was measured once, after the participant sat quietly for at least 5 minutes. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the HR at specified visit minus the Baseline value.

    Measured: Up to 70 Weeks (including follow up)

  5. Change From Baseline in Vital Sign Body Weight (BW)

    BW was measured at all visits, without shoes and wearing light clothing. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the body weight at specified visit minus the Baseline value.

    Measured: Up to 70 Weeks (including follow up)

  6. Change From Baseline in Non-fasting Measures of Lipid Metabolism Namely Total Cholesterol (TC), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides

    The clinical chemistry data included non-fasting measures of lipid metabolism (TC,HDL,LDL,triglycerides). Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the lipids (TC,HDL,LDL,triglycerides) value recorded at specified visit minus the Baseline value.

    Measured: Up to 82 Weeks (including follow up)

  7. Number of Participants With SBP and DBP Values of Potential Clinical Concern (PCC)

    The frequency of participant vital sign sitting blood pressure was obtained to check if the values lie outside of a pre-determined reference range (RR) for SBP 90-140 mmHg, DBP 50-90 mmHg or have a change from Baseline of PCC for SBP increase from Baseline (IFB) >=40, decrease from Baseline (DFB) >= 30 for and for DBP (IFB) >= 30 ,DFB >= 20. The number of participants with values of PCC at any time on treatment (ATOT) and follow up were reported.

    Measured: Up to 70 Weeks (including follow up)

  8. Number of Participants With HR Values of PCC ATOT

    HR was measured once, after the participant sat quietly for at least 5 minutes. The frequency of participant vital sign heart rate was obtained to check if the values lie outside of a pre-determined reference range (RR) 50-100 bpm or have a change from Baseline of PCC IFB >=30 and DFB >=30. The number of participants with values of PCC including follow up were reported.

    Measured: Up to 70 Weeks (including follow up)

  9. Number of Participants With BW Values of PCC ATOT

    The frequency of participant vital sign weight was obtained to check if the values have CFB of PCC IFB >=7 percent. With the exception of Week 4, when participants were first titrated to the 8mg RSG XR dose, at every time point in the study where weight was measured the percentage of participants experienced an increase in BW of PCC was approximately 2 times greater than the percentage of participants experiencing an decrease in BW of PCC DFB >=7 percent. The number of participants with values of PCC including follow up were reported.

    Measured: Up to 70 Weeks (including follow up)

  10. Number of Participants With Hematology Parameters of PCC ATOT

    The hematology data included eosinophils, haematocrit, haemoglobin, lymphocytes, mean corpuscular haemoglobin (MCH), mean corpuscular volume (MCV), monocytes, platelet count, red cell distribution width (RDW), red blood cell (RBC) count, segmented neutrophils (SN), total neutrophils (TN), white blood cell (WBC) count. The number of participants with values of PCC (defined as high and low) ATOT were reported.

    Measured: Up to Week 82 (including follow up)

  11. Number of Participants With Clinical Chemistry Parameters (Including Lipids) of PCC ATOT

    The clinical chemistry data included alanine amino transferase (ALT), albumin, aldolase, asparatate amino transferase (AST), BUN/creatinine ratio, carbon dioxide(CO2) content, chloride, cholesterol, creatinine kinase (CK), creatinine, direct bilirubin (DB), gamma glutamyl transferase (GGT), glucose, glycosylated Hemoglobin (HbA1C), HDL, LDL, lactate dehydrogenase (LD), magnesium, potassium, sodium, total bilirubin (TB), triglycerides, troponin I, urea. The number of participants with values of PCC (defined as high and low) ATOT were reported.

    Measured: Up to Week 82 (including follow up)

  12. Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Total Score as a Function of Apolipoprotein E (APOE) ε4 Status.

    The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores ranged from 0 to 70 with higher scores indicating greater dysfunction. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.

    Measured: Baseline (Week 0) and Week 24, 52

  13. Change From Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score as a Function of APOE ε4 Status.

    The CDR-SB is a validated clinical assessment of global function in par. with Alzheimer's disease (AD). Impairment was scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or box scores, were added together to give the CDR-Sum of Boxes which ranged from 0 to 18 (severe impairment). Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.

    Measured: Baseline (Week 0) and Week 24, 52

  14. Change From Baseline in Mini Mental State Examination (MMSE) Total Score as a Function of APOE ε4 Status.

    The MMSE consisted of 11 tests of orientation, memory (recent and immediate), concentration, language and praxis. Scores ranged from 0 to 30, with lower scores indicating greater cognitive impairment. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.

    Measured: Baseline (Week 0) and Week 24, 52

  15. Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score as a Function of APOE ε4 Status.

    DAD, assessed the ability of a participant to execute basic and instrumental activities of daily living (ADL) and leisure activities. The scale consists of 40 questions assessing basic and instrumental ADLs. This scale assesses a participant's ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item was scored as yes: 1, no: 0 and N/A: not applicable. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability. The percentage score was calculated as (DAD total score/total number of applicable items) * 100. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.

    Measured: Baseline (Week 0) and Week 24, 52

  16. Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score as a Function of APOE ε4 Status.

    12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, motor disturbance, appetite, nighttime behavior. A screening question is asked about each sub-domain. If the responses to these questions=participant has problems with a particular sub-domain of behavior, the caregiver asked all the questions about that domain, rating the frequency (1=occasionally to 4=very frequently) on a 4-point scale, their severity (1=Mild to 3=Severe) on a 3-point scale, and the distress on a 5-point scale. Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.

    Measured: Baseline (Week 0) and Week 24, 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2007 (estimated)
  2. Study start8 Aug 2007
  3. Primary completion1 Jun 2009
  4. Study completion1 Jun 2009

Why it stopped: Based on preliminary parent study results

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,461 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00490568
Sponsor's protocol ID
AVA102675
Status last verified
Sep 2017
First submitted
21 Jun 2007
Last updated
13 Nov 2017

Publications

  • Harrington C, Sawchak S, Chiang C, Davies J, Donovan C, Saunders AM, Irizarry M, Jeter B, Zvartau-Hind M, van Dyck CH, Gold M. 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 Aug;8(5):592-606. doi: 10.2174/156720511796391935.

    PubMed 21592048

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rosiglitazone XR in people with Alzheimer's Disease, run by GlaxoSmithKline at 272 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 272 sites in Germany, United States, France, Canada, Italy and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Any Adverse Events (AEs) and Severity of AEs (time frame: Up to 76 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00490568, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in