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



Status:Terminated
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:51 - 91
Updated:10/14/2017
Start Date:August 2007
End Date:June 2009

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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 Alzheimer's 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.


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.
We found this trial at
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Sherman Oaks, California 91403
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Albany, New York 12206
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Austin, Texas 78705
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Bennington, Vermont 05201
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Brooklyn, New York 11215
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Ciudad Autonoma de Buenos Aires, Buenos Aires
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Columbus, Ohio 43219
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Deerfield Beach, Florida 33441
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Delray Beach, Florida 33484
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Fort Wayne, Indiana 46825
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Fresno, California 93720
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Hialeah, Florida 33013
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Litchfield Park, Arizona 85340
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Little Rock, Arkansas 72205
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Milwaukee, Wisconsin 53215
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Morristown, New Jersey 07962
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New Haven, Connecticut 06520
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New York, New York 10032
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Norwalk, Connecticut 06850
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Ocala, Florida 34471
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Phoenix, Arizona 85012
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Pittsburgh, Pennsylvania 15213
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Providence, Rhode Island 02903
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Raleigh, North Carolina 27614
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Rancho Mirage, California 92270
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Rockville, Maryland 20850
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Sacramento, California 95815
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San Diego, California 92111
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San Francisco, California 94115
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South Ogden, Utah 84403
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Springfield, Massachusetts 01199
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St. Paul, Minnesota 55102
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St. Petersburg, Florida 33707
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Stratford, New Jersey 08084
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Syracuse, New York 13210
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Toledo, Ohio 43608
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Toms River, New Jersey 08755
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Tucson, Arizona 85724
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Tulsa, Oklahoma 74105
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West Palm Beach, Florida 33409
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West Yarmouth, Massachusetts 02673
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Winston-Salem, North Carolina 27103
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