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

October 11, 2017 updated by: GlaxoSmithKline

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.

Study Overview

Status

Terminated

Conditions

Alzheimer's Disease

Intervention / Treatment

Drug: Rosiglitazone XR

Study Type

Interventional

Enrollment (Actual)

1461

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Ciudad Autonoma de Buenos Aires, Argentina, C1425CDC
    - GSK Investigational Site
  - Mendoza, Argentina, CPM5500HIF
    - GSK Investigational Site
- Buenos Aires
  - Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1192AAW
    - GSK Investigational Site
  - Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1419HDN
    - GSK Investigational Site
  - Ciudad de Buenos Aires, Buenos Aires, Argentina, C1431FWO
    - GSK Investigational Site
- Córdova
  - Cordoba, Córdova, Argentina, 5000
    - GSK Investigational Site
  - Córdoba, Córdova, Argentina, X5004AOA
    - GSK Investigational Site
  - Córdoba, Córdova, Argentina, x5009bin
    - GSK Investigational Site
- Mendoza
  - Godoy Cruz, Mendoza, Argentina, M5504FMI
    - GSK Investigational Site
Australia
- New South Wales
  - Hornsby, New South Wales, Australia, 2077
    - GSK Investigational Site
  - Randwick, New South Wales, Australia, 2031
    - GSK Investigational Site
- Queensland
  - Auchenflower, Queensland, Australia, 4066
    - GSK Investigational Site
  - Chermside, Queensland, Australia, 4032
    - GSK Investigational Site
  - Kippa Ring, Queensland, Australia, 4021
    - GSK Investigational Site
- South Australia
  - Woodville, South Australia, Australia, 5011
    - GSK Investigational Site
- Victoria
  - Cheltenham, Victoria, Australia, 3192
    - GSK Investigational Site
  - Heidelberg Heights, Victoria, Australia, 3084
    - GSK Investigational Site
  - Kew, Victoria, Australia, 3101
    - GSK Investigational Site
- Western Australia
  - Nedlands, Western Australia, Australia, 6009
    - GSK Investigational Site
Austria
- - Hall in Tirol, Austria, A-6060
    - GSK Investigational Site
  - Vienna, Austria, 1010
    - GSK Investigational Site
  - Vienna, Austria, 1030
    - GSK Investigational Site
  - Vienna, Austria, A-1130
    - GSK Investigational Site
  - Vienna, Austria, A-1220
    - GSK Investigational Site
Belgium
- - Kortrijk, Belgium, 8500
    - GSK Investigational Site
  - Leuven, Belgium, 3000
    - GSK Investigational Site
  - Woluwe-Saint-Lambert, Belgium, 1200
    - GSK Investigational Site
Bulgaria
- - Sofia, Bulgaria, 1431
    - GSK Investigational Site
  - Sofia, Bulgaria, 1527
    - GSK Investigational Site
  - Sofia, Bulgaria, 1113
    - GSK Investigational Site
  - Varna, Bulgaria, 9010
    - GSK Investigational Site
Canada
- - Québec, Canada, G1R 3X5
    - GSK Investigational Site
- New Brunswick
  - Saint John, New Brunswick, Canada, E2L 3L6
    - GSK Investigational Site
- Nova Scotia
  - Kentville, Nova Scotia, Canada, B4N 4K9
    - GSK Investigational Site
- Ontario
  - Kingston, Ontario, Canada, K7L 5G2
    - GSK Investigational Site
  - Kingston, Ontario, Canada, K7L 4X3
    - GSK Investigational Site
  - Ottawa, Ontario, Canada, K1G 4G3
    - GSK Investigational Site
  - Ottawa, Ontario, Canada, K1N 5C8
    - GSK Investigational Site
  - Peterborough, Ontario, Canada, K9H 2P4
    - GSK Investigational Site
  - Toronto, Ontario, Canada, M5T 2S8
    - GSK Investigational Site
  - Toronto, Ontario, Canada, M6M 3Z5
    - GSK Investigational Site
  - Toronto, Ontario, Canada, M3B 2S7
    - GSK Investigational Site
  - Whitby, Ontario, Canada, L1N 5S9
    - GSK Investigational Site
- Prince Edward Island
  - Charlottetown, Prince Edward Island, Canada, C1A 5Y8
    - GSK Investigational Site
- Quebec
  - Greenfield Park, Quebec, Canada, J4V 2J2
    - GSK Investigational Site
  - Montreal, Quebec, Canada, H1T 2M4
    - GSK Investigational Site
  - Montreal, Quebec, Canada, H4H 1R3
    - GSK Investigational Site
  - Sherbrooke, Quebec, Canada, J1H 1Z1
    - GSK Investigational Site
  - Sherbrooke, Quebec, Canada, J1J 3H5
    - GSK Investigational Site
- Saskatchewan
  - Regina, Saskatchewan, Canada, S4T 1A5
    - GSK Investigational Site
Chile
- Región Metro De Santiago
  - Providencia / Santiago, Región Metro De Santiago, Chile, 7500710
    - GSK Investigational Site
  - Santiago, Región Metro De Santiago, Chile, 7560356
    - GSK Investigational Site
- Valparaíso
  - Viña del Mar, Valparaíso, Chile, 252-0997
    - GSK Investigational Site
Czechia
- - Olomouc, Czechia, 775 20
    - GSK Investigational Site
  - Ostrava, Czechia, 702 00
    - GSK Investigational Site
  - Praha 10, Czechia, 10000
    - GSK Investigational Site
  - Praha 2, Czechia, 120 00
    - GSK Investigational Site
  - Praha 5, Czechia, 150 18
    - GSK Investigational Site
  - Praha 7, Czechia, 170 00
    - GSK Investigational Site
  - Praha 8, Czechia, 180 00
    - GSK Investigational Site
  - Trutnov, Czechia, 541 01
    - GSK Investigational Site
Finland
- - Helsinki, Finland, 00120
    - GSK Investigational Site
  - Kuopio, Finland, 70211
    - GSK Investigational Site
France
- - 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, 13008
    - GSK Investigational Site
  - Marseille, France, 13009
    - GSK Investigational Site
  - Metz, France, 57038
    - GSK Investigational Site
  - Nantes, France, 44093
    - GSK Investigational Site
  - Nantes, France, 44300
    - GSK Investigational Site
  - Nantes, France, 44000
    - 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
    - GSK Investigational Site
Germany
- - Berlin, Germany, 12167
    - GSK Investigational Site
  - Berlin, Germany, 12163
    - GSK Investigational Site
  - Berlin, Germany, 13156
    - GSK Investigational Site
  - Berlin, Germany, 12555
    - GSK Investigational Site
  - Berlin, Germany, 13357
    - GSK Investigational Site
  - Berlin, Germany, 13439
    - GSK Investigational Site
  - Hamburg, Germany, 21149
    - GSK Investigational Site
  - Hamburg, Germany, 22083
    - GSK Investigational Site
- Baden-Wuerttemberg
  - Aalen, Baden-Wuerttemberg, Germany, 73430
    - GSK Investigational Site
  - Ellwangen, Baden-Wuerttemberg, Germany, 73479
    - GSK Investigational Site
  - Ludwigsburg, Baden-Wuerttemberg, Germany, 71634
    - GSK Investigational Site
  - Ostfildern, Baden-Wuerttemberg, Germany, 73760
    - GSK Investigational Site
  - Stuttgart, Baden-Wuerttemberg, Germany, 70176
    - GSK Investigational Site
  - Tuebingen, Baden-Wuerttemberg, Germany, 72076
    - GSK Investigational Site
  - Ulm, Baden-Wuerttemberg, Germany, 89075
    - GSK Investigational Site
- Bayern
  - Alzenau, Bayern, Germany, 63755
    - GSK Investigational Site
  - Muenchen, Bayern, Germany, 81675
    - GSK Investigational Site
  - Muenchen, Bayern, Germany, 80333
    - GSK Investigational Site
  - Muenchen, Bayern, Germany, 80331
    - GSK Investigational Site
  - Muenchen, Bayern, Germany, 81667
    - GSK Investigational Site
  - Nuernberg, Bayern, Germany, 90402
    - GSK Investigational Site
  - Regensburg, Bayern, Germany, 93053
    - GSK Investigational Site
  - Unterhaching, Bayern, Germany, 82008
    - GSK Investigational Site
- Brandenburg
  - Bad Saarow, Brandenburg, Germany, 15526
    - GSK Investigational Site
- Hessen
  - Bad Homburg, Hessen, Germany, 61348
    - GSK Investigational Site
  - Erbach, Hessen, Germany, 64711
    - GSK Investigational Site
- Mecklenburg-Vorpommern
  - Schwerin, Mecklenburg-Vorpommern, Germany, 19053
    - GSK Investigational Site
- Niedersachsen
  - Achim, Niedersachsen, Germany, 28832
    - GSK Investigational Site
  - Bockhorn, Niedersachsen, Germany, 26345
    - GSK Investigational Site
  - Ganderkesee, Niedersachsen, Germany, 27777
    - GSK Investigational Site
  - Goettingen, Niedersachsen, Germany, 37075
    - GSK Investigational Site
  - Hannover, Niedersachsen, Germany, 30559
    - GSK Investigational Site
  - Lueneburg, Niedersachsen, Germany, 21335
    - GSK Investigational Site
  - Westerstede, Niedersachsen, Germany, 26655
    - GSK Investigational Site
- Nordrhein-Westfalen
  - Bad Honnef, Nordrhein-Westfalen, Germany, 53604
    - GSK Investigational Site
  - Baesweiler, Nordrhein-Westfalen, Germany, 52499
    - GSK Investigational Site
  - Bergisch Gladbach, Nordrhein-Westfalen, Germany, 51465
    - GSK Investigational Site
  - Bochum, Nordrhein-Westfalen, Germany, 44791
    - GSK Investigational Site
  - Bochum, Nordrhein-Westfalen, Germany, 44805
    - GSK Investigational Site
  - Bochum, Nordrhein-Westfalen, Germany, 44869
    - GSK Investigational Site
  - Dueren, Nordrhein-Westfalen, Germany, 52349
    - GSK Investigational Site
  - Duisburg, Nordrhein-Westfalen, Germany, 47051
    - GSK Investigational Site
  - Essen, Nordrhein-Westfalen, Germany, 45138
    - GSK Investigational Site
  - Hattingen, Nordrhein-Westfalen, Germany, 45525
    - GSK Investigational Site
  - Juelich, Nordrhein-Westfalen, Germany, 52428
    - GSK Investigational Site
  - Koeln, Nordrhein-Westfalen, Germany, 50767
    - GSK Investigational Site
  - Krefeld, Nordrhein-Westfalen, Germany, 47800
    - GSK Investigational Site
  - Siegen, Nordrhein-Westfalen, Germany, 57072
    - GSK Investigational Site
- Sachsen
  - Chemnitz, Sachsen, Germany, 09111
    - GSK Investigational Site
  - Dresden, Sachsen, Germany, 01307
    - GSK Investigational Site
  - Dresden, Sachsen, Germany, 01097
    - GSK Investigational Site
  - Leipzig, Sachsen, Germany, 04107
    - GSK Investigational Site
  - Leipzig, Sachsen, Germany, 04157
    - GSK Investigational Site
- Thueringen
  - Gera, Thueringen, Germany, 07551
    - GSK Investigational Site
  - Jena, Thueringen, Germany, 07743
    - GSK Investigational Site
Greece
- - Athens, Greece, 115 21
    - GSK Investigational Site
  - Athens, Greece, 151 23
    - GSK Investigational Site
  - Melissia, Greece, 151 27
    - GSK Investigational Site
  - Thessaloniki, Greece, 57010
    - GSK Investigational Site
Hong Kong
- - Hong Kong, Hong Kong
    - GSK Investigational Site
  - Shatin, Hong Kong
    - GSK Investigational Site
Hungary
- - Győr, Hungary, 9024
    - GSK Investigational Site
  - Szeged, Hungary, 6725
    - GSK Investigational Site
India
- - Hyderabad, India, 500 034
    - GSK Investigational Site
  - Nagpur, India, 440010
    - GSK Investigational Site
  - New Delhi, India, 110002
    - GSK Investigational Site
  - Pune, India, 411004
    - GSK Investigational Site
  - Varanasi, India, 221005
    - GSK Investigational Site
Italy
- Abruzzo
  - Chieti Scalo, Abruzzo, Italy, 66013
    - GSK Investigational Site
- Campania
  - Napoli, Campania, Italy, 80131
    - GSK Investigational Site
  - San Felice a Cancello Caserta, Campania, Italy, 81027
    - GSK Investigational Site
- Lazio
  - Roma, Lazio, Italy, 00163
    - GSK Investigational Site
  - Roma, Lazio, Italy, 00148
    - GSK Investigational Site
  - Roma, Lazio, Italy, 00186
    - GSK Investigational Site
- Lombardia
  - Brescia, Lombardia, Italy, 25125
    - GSK Investigational Site
  - Milano, Lombardia, Italy, 20127
    - GSK Investigational Site
  - Milano, Lombardia, Italy, 20122
    - GSK Investigational Site
  - Pavia, Lombardia, Italy, 27100
    - GSK Investigational Site
  - Rho, Lombardia, Italy, 20017
    - GSK Investigational Site
- Marche
  - Torrette (AN), Marche, Italy, 60020
    - GSK Investigational Site
- Toscana
  - Arezzo, Toscana, Italy, 52100
    - GSK Investigational Site
  - Firenze, Toscana, Italy, 50134
    - GSK Investigational Site
  - Pisa, Toscana, Italy, 56126
    - GSK Investigational Site
Korea, Republic of
- - Seongnam-si,, Korea, Republic of, 463-707
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 138-736
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 150-713
    - GSK Investigational Site
Mexico
- - Mexico, Mexico, 14000
    - GSK Investigational Site
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64660
    - GSK Investigational Site
  - Monterrey, Nuevo León, Mexico, 64710
    - GSK Investigational Site
Netherlands
- - Alkmaar, Netherlands, 1815 JD
    - GSK Investigational Site
  - Blaricum, Netherlands, 1261 AN
    - GSK Investigational Site
  - Den Bosch, Netherlands, 5232 JL
    - GSK Investigational Site
  - Den Haag, Netherlands, 2545 CH
    - GSK Investigational Site
  - Hengelo, Netherlands, 7555 DL
    - GSK Investigational Site
  - Hilversum, Netherlands, 1213 XZ
    - GSK Investigational Site
Philippines
- - Pasig City, Philippines, 1600
    - GSK Investigational Site
Poland
- - Bydgoszcz, Poland, 85-796
    - GSK Investigational Site
  - Bydgoszcz, Poland, 85-096
    - GSK Investigational Site
  - Katowice, Poland, 40-752
    - GSK Investigational Site
  - Mosina, Poland, 62-050
    - GSK Investigational Site
  - Poznan, Poland, 61-298
    - GSK Investigational Site
  - Sopot, Poland, 81-824
    - GSK Investigational Site
  - Warsaw, Poland, 02-097
    - GSK Investigational Site
Portugal
- - Coimbra, Portugal, 3000-548
    - GSK Investigational Site
  - Lisboa, Portugal, 1649-035
    - GSK Investigational Site
Slovakia
- - Bratislava, Slovakia, 811 01
    - GSK Investigational Site
  - Bratislava, Slovakia, 811 07
    - GSK Investigational Site
  - Bratislava, Slovakia, 825 56
    - GSK Investigational Site
  - Kosice, Slovakia, 041 66
    - GSK Investigational Site
Slovenia
- - Ljubljana, Slovenia, 1000
    - GSK Investigational Site
  - Šempeter, Slovenia, 5290
    - GSK Investigational Site
South Africa
- - Loeventstein, South Africa, 7530
    - GSK Investigational Site
  - Oakdale, South Africa, 7530
    - GSK Investigational Site
  - Richards Bay, South Africa, 3900
    - GSK Investigational Site
  - Rosebank, South Africa, 2196
    - GSK Investigational Site
  - Somerset West, South Africa, 7130
    - GSK Investigational Site
  - Waverley, Bloemfontein, South Africa, 9301
    - GSK Investigational Site
  - Willows, X14, Pretoria, South Africa, 0040
    - GSK Investigational Site
Spain
- - Barcelona, Spain, 08036
    - GSK Investigational Site
  - Barcelona, Spain, 08003
    - GSK Investigational Site
  - Barcelona, Spain, 08907
    - GSK Investigational Site
  - Barcelona, Spain, 08014
    - GSK Investigational Site
  - Burgos, Spain, 09006
    - GSK Investigational Site
  - Castellón, Spain, 12004
    - GSK Investigational Site
  - Elche (Alicante), Spain, 03202
    - GSK Investigational Site
  - Gerona, Spain, 17190
    - GSK Investigational Site
  - Madrid, Spain, 28006
    - GSK Investigational Site
  - Murcia, Spain, 30120
    - GSK Investigational Site
  - Palma de Mallorca, Spain, 07014
    - GSK Investigational Site
  - Tarrasa, Barcelona, Spain, 08221
    - GSK Investigational Site
  - Valencia, Spain, 46010
    - GSK Investigational Site
Sweden
- - Jönköping, Sweden, SE-551 85
    - GSK Investigational Site
  - Kalix, Sweden, SE-952 82
    - GSK Investigational Site
  - Mölndal, Sweden, SE-431 41
    - GSK Investigational Site
  - Sundsvall, Sweden, SE-851 86
    - GSK Investigational Site
  - Umeå, Sweden, SE-901 85
    - GSK Investigational Site
United Kingdom
- - Bradford, United Kingdom, BD3 0DQ
    - GSK Investigational Site
  - Liverpool, United Kingdom, L9 7LJ
    - GSK Investigational Site
  - West of Scotland Science Park, Glasgow, United Kingdom, G20 0XA
    - GSK Investigational Site
- Lancashire
  - Blackpool, Lancashire, United Kingdom, FY2 0JH
    - GSK Investigational Site
United States
- Arizona
  - Litchfield Park, Arizona, United States, 85340
    - GSK Investigational Site
  - Phoenix, Arizona, United States, 85013
    - GSK Investigational Site
  - Tucson, Arizona, United States, 85741
    - GSK Investigational Site
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - GSK Investigational Site
- California
  - Fresno, California, United States, 93720
    - GSK Investigational Site
  - Rancho Mirage, California, United States, 92270
    - GSK Investigational Site
  - Sacramento, California, United States, 95816
    - GSK Investigational Site
  - San Diego, California, United States, 92103
    - GSK Investigational Site
  - San Francisco, California, United States, 94109
    - GSK Investigational Site
  - Sherman Oaks, California, United States, 91403
    - GSK Investigational Site
- Connecticut
  - New Haven, Connecticut, United States, 06510
    - GSK Investigational Site
  - Norwalk, Connecticut, United States, 06851
    - GSK Investigational Site
- Florida
  - Deerfield Beach, Florida, United States, 33064
    - GSK Investigational Site
  - Delray Beach, Florida, United States, 33445
    - GSK Investigational Site
  - Hialeah, Florida, United States, 33016
    - GSK Investigational Site
  - Ocala, Florida, United States, 34471
    - GSK Investigational Site
  - Saint Petersburg, Florida, United States, 33702
    - GSK Investigational Site
  - West Palm Beach, Florida, United States, 33407
    - GSK Investigational Site
- Indiana
  - Fort Wayne, Indiana, United States, 46805
    - GSK Investigational Site
- Maryland
  - Rockville, Maryland, United States, 20852
    - GSK Investigational Site
- Massachusetts
  - Springfield, Massachusetts, United States, 01104
    - GSK Investigational Site
  - West Yarmouth, Massachusetts, United States, 02673
    - GSK Investigational Site
- Minnesota
  - Saint Paul, Minnesota, United States, 55101
    - GSK Investigational Site
- New Jersey
  - Morristown, New Jersey, United States, 07960
    - GSK Investigational Site
  - Stratford, New Jersey, United States, 08084
    - GSK Investigational Site
  - Toms River, New Jersey, United States, 08755
    - GSK Investigational Site
- New York
  - Albany, New York, United States, 12205
    - GSK Investigational Site
  - Brooklyn, New York, United States, 11235
    - GSK Investigational Site
  - New York, New York, United States, 10016
    - GSK Investigational Site
  - Syracuse, New York, United States, 13210
    - GSK Investigational Site
- North Carolina
  - Raleigh, North Carolina, United States, 27607
    - GSK Investigational Site
  - Winston-Salem, North Carolina, United States, 27103
    - GSK Investigational Site
- Ohio
  - Columbus, Ohio, United States, 43210
    - GSK Investigational Site
  - Toledo, Ohio, United States, 43623
    - GSK Investigational Site
- Oklahoma
  - Tulsa, Oklahoma, United States, 74104
    - GSK Investigational Site
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15213
    - GSK Investigational Site
- Rhode Island
  - Providence, Rhode Island, United States, 02906
    - GSK Investigational Site
- Texas
  - Austin, Texas, United States, 78757
    - GSK Investigational Site
- Utah
  - South Ogden, Utah, United States, 84403
    - GSK Investigational Site
- Vermont
  - Bennington, Vermont, United States, 05201
    - GSK Investigational Site
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years to 91 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rosiglitazone XR Investigational drug	Drug: Rosiglitazone XR Experimental drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Any Adverse Events (AEs) and Severity of AEs Time Frame: Up to 76 Weeks	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.	Up to 76 Weeks

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Helpful Links

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

June 21, 2007

First Submitted That Met QC Criteria

June 21, 2007

First Posted (Estimate)

June 22, 2007

Study Record Updates

Last Update Posted (Actual)

November 13, 2017

Last Update Submitted That Met QC Criteria

October 11, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

AVA102675

Plan for Individual participant data (IPD)

Study Data/Documents

Individual Participant Data Set
Information identifier: AVA102675

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form
Information identifier: AVA102675

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report
Information identifier: AVA102675

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan
Information identifier: AVA102675

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol
Information identifier: AVA102675

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form
Information identifier: AVA102675

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification
Information identifier: AVA102675

Information comments: For additional information about this study please refer to the GSK Clinical Study Register

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Clinical Trials on Alzheimer's Disease

University of Southern California
Alzheimer's Therapeutic Research Institute; American Heart Association; Schaeffer...

Recruiting

Financial Incentives and Recruitment to the APT Webstudy (FIND-AD)

Dementia | Alzheimer Disease | Prodromal Alzheimer's Disease | Preclinical Alzheimer's Disease

United States
University of Southern California
National Institute on Aging (NIA); Alzheimer's Therapeutic Research Institute; Brigham and Women's Hospital and other collaborators

Active, not recruiting

TRC-PAD Program: In-Clinic Trial-Ready Cohort (TRC-PAD)

Dementia | Alzheimer Disease | Prodromal Alzheimer's Disease | Preclinical Alzheimer's Disease

United States
Novoic Limited

Recruiting

Amyloid Prediction in Early Stage Alzheimer's Disease Through Speech Phenotyping - FUTURE Extension (FUTURE-US)

Alzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's Disease

United States
Novoic Limited

Recruiting

Amyloid Prediction in Early Stage Alzheimer's Disease From Acoustic and Linguistic Patterns of Speech - PAST Extension (AMYPRED-PAST)

Alzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's Disease

United Kingdom
Novoic Limited

Completed

Amyloid Prediction in Early Stage Alzheimer's Disease Through Speech Phenotyping (AMYPRED-US)

Alzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's Disease

United States
Novoic Limited

Recruiting

Amyloid Prediction in Early Stage Alzheimer's Disease From Acoustic and Linguistic Patterns of Speech - FUTURE Extension (AMYPRED-FUTURE)

Alzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's Disease

United Kingdom
Novoic Limited

Completed

Amyloid Prediction in Early Stage Alzheimer's Disease From Acoustic and Linguistic Patterns of Speech (AMYPRED)

Alzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's Disease

United Kingdom
University Hospital, Bordeaux
Ministry for Health and Solidarity, France

Completed

MEMENTO-VAScular COmponents of Dementia (VASCOD)

Alzheimer's Disease (AD) | Alzheimer's Disease (AD) Related Disorders

France
Novoic Limited

Recruiting

Amyloid Prediction in Early Stage Alzheimer's Disease Through Speech Phenotyping - PAST Extension (PAST-US)

Alzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's Disease | Normal Cognition

United States
University of Colorado, Denver
National Institute on Aging (NIA)

Active, not recruiting

VIdeo Telehealth in ALzheimer's: NeuroPsychology (VITAL-NP) (VITAL-NP)

Suspected Typical Alzheimer's Disease (AD) | Suspected Atypical Alzheimer's Disease (AD)

United States

Clinical Trials on Rosiglitazone XR

GlaxoSmithKline

Terminated

Study Of Rosiglitazone XR In Subjects With Mild-to-Moderate Alzheimers

Alzheimer's Disease

United States, Bulgaria, Germany, Estonia, Korea, Republic of, China, Greece, Hungary, Russian Federation, Philippines, Austria, Chile, Mexico, Croatia, New Zealand, Peru, Puerto Rico, United Kingdom
GlaxoSmithKline

Completed

PK, Dose Proportionality, Food Effect And Repeat Dose Study Of Rosiglitazone XR In Healthy Volunteers (Rosi XR)

Alzheimer's Disease

Germany
GlaxoSmithKline

Completed

The Anti-Inflammatory And Metabolic Effects Of Rosiglitazone In Subjects With Rheumatoid Arthritis

Arthritis, Rheumatoid

Lithuania, United Kingdom
GlaxoSmithKline

Terminated

Effects Of Rosiglitazone (Extended Release Tablets) On Cerebral Glucose Utilisation And Cognition Alzheimers Disease

Alzheimer's Disease

United Kingdom
Solvay Pharmaceuticals

Completed

A Methodological Study To Evaluate The Effects of Single Oral Doses Of Pioglitazone 45 mg And Rosiglitazone 8 mg On Sodium Balance In Healthy Male Volunteers

Type 2 Diabetes Mellitus

United Kingdom
Centre Hospitalier Universitaire Dijon

Completed

Influence of Glitazones on the Vasodilatory Effect of High-density Lipoprotein (HDL) Lipoproteins

Type 2 Diabetes

France
GlaxoSmithKline

Completed

Efficacy and Safety In Poorly Controlled Type 2 Diabetics

Diabetes Mellitus, Type 2
GlaxoSmithKline

Completed

A Study Of BRL49653C For The Treatment Of Type 2 Diabetes

Diabetes Mellitus, Type 2
GlaxoSmithKline

Completed

Fluid Retention in Rosiglitazone Treated Subjects With Autonomic Neuropathy.

Neuropathy, Diabetic

Netherlands
Medstar Health Research Institute
GlaxoSmithKline

Terminated

Ppar-Gamma EliminAtes Restenosis Longevity Study: PEARLS

Metabolic Syndrome

United States

Outcome Measure	Measure Description	Time Frame
Number Participants With Serious Adverse Events (SAEs) and Deaths Time Frame: Up to 76 Weeks	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.	Up to 76 Weeks
Number of Participants With Adverse Event of Oedema Time Frame: Up to 76 Weeks	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.	Up to 76 Weeks
Change From Baseline in Vital Sign Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Time Frame: Up to 70 Weeks (including follow up)	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.	Up to 70 Weeks (including follow up)
Change From Baseline in Vital Sign Heart Rate (HR) Time Frame: Up to 70 Weeks (including follow up)	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.	Up to 70 Weeks (including follow up)
Change From Baseline in Vital Sign Body Weight (BW) Time Frame: Up to 70 Weeks (including follow up)	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.	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 Time Frame: Up to 82 Weeks (including follow up)	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.	Up to 82 Weeks (including follow up)
Number of Participants With SBP and DBP Values of Potential Clinical Concern (PCC) Time Frame: Up to 70 Weeks (including follow up)	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.	Up to 70 Weeks (including follow up)
Number of Participants With HR Values of PCC ATOT Time Frame: Up to 70 Weeks (including follow up)	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.	Up to 70 Weeks (including follow up)
Number of Participants With BW Values of PCC ATOT Time Frame: Up to 70 Weeks (including follow up)	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.	Up to 70 Weeks (including follow up)
Number of Participants With Hematology Parameters of PCC ATOT Time Frame: Up to Week 82 (including follow up)	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.	Up to Week 82 (including follow up)
Number of Participants With Clinical Chemistry Parameters (Including Lipids) of PCC ATOT Time Frame: Up to Week 82 (including follow up)	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.	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. Time Frame: Baseline (Week 0) and Week 24, 52	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.	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. Time Frame: Baseline (Week 0) and Week 24, 52	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.	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. Time Frame: Baseline (Week 0) and Week 24, 52	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.	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. Time Frame: Baseline (Week 0) and Week 24, 52	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.	Baseline (Week 0) and Week 24, 52
Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score as a Function of APOE ε4 Status. Time Frame: Baseline (Week 0) and Week 24, 52	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.	Baseline (Week 0) and Week 24, 52

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

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.

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Clinical Trials on Alzheimer's Disease

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