Trial record 1 of 1 for:    NCT00550420
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Study Of Rosiglitazone XR 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:
NCT00550420
First received: October 25, 2007
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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 AVA105640. 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. 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 AVA105640. 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


Condition Intervention Phase
Alzheimer's Disease
Drug: Rosiglitazone XR
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Extension Study of the Long-term Safety and Efficacy of Rosiglitazone Extended-release (RSG XR) in Subjects With Mild-to-moderate Alzheimer's Disease (REFLECT-5)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Incidence and severity of Adverse Events. [ Time Frame: 52 weeks ]

Secondary Outcome Measures:
  • ADAS-cog, CIBIC+, 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 ]

Enrollment: 383
Study Start Date: October 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Rosiglitazone XR
Drug: Rosiglitazone XR
experimental drug

  Eligibility

Ages Eligible for Study:   51 Years to 91 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Male or female subject who has successfully completed Visit 8 of AVA105640 without safety/tolerability issues, where in the opinion of the subject /carer and of the investigator, it would be beneficial to receive RSG XR
  • Female subjects able to bear children must agree to use an adequate method of contraception for the duration of the study for details of highly effective methods to avoid pregnancy). Female subjects who are pre-menopausal or who have been post-menopausal for <1 year must undertake pregnancy testing (urine test) £7 days before Visit 1, which must be negative
  • Subject is willing to participate in the extension study and has provided full written informed consent prior to the performance of any protocol-specified procedure; or if unable to provide informed consent due to cognitive status, full written informed consent on behalf of the subject has been provided by a legally acceptable representative (where this is in accordance with local laws, regulations and ethics committee policy)
  • Subject lives with (or has substantial periods of contact with) a regular caregiver who is willing to attend all visits, oversee the subject's compliance with protocol-specified procedures and study medication, and report on subject's status
  • Subject has the ability to comply with procedures for cognitive and other testing
  • Caregiver has provided full written informed consent on his or her own behalf prior to the performance of any protocol-specified procedure
  • Subjects considered for enrollment must have a QTc (either QTc B (Bazett's correction) or QTc F (Fridericia's correction)) <450msec at Visit 1, with the exception of subjects with bundle branch block (for whom either QTc B or QTc F must be <480msec)
  • In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category
  • Post-menopause [Becker, 2001]: Menopause is the age associated with complete cessation of menstrual cycles, menses, and implies the loss of reproductive potential by ovarian failure. This typically occurs around age 50, although it may occur earlier. A practical definition accepts menopause after one year without menses with an appropriate clinical profile, e.g., age appropriate, >45 years, in the absence of hormone replacement therapy. In questionable cases, a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory (these levels are suggested guidelines and may need to be adjusted for specific laboratories/assays
  • Females, who are on hormone replacement therapy (HRT), and whose menopausal status is in doubt, will be required to use a highly effective method to avoid pregnancy, as outlined in the protocol, if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post‑menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw as detailed in the preceding paragraph; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a highly effective method to avoid pregnancy
  • A non-cohabiting caregiver must spend sufficient time with the subject so that, in the opinion of the Investigator, the caregiver can reliably assess cognitive function, activities and behaviour, and report on the subject's compliance and health. As caregiver time spent with a potential subject is anticipated to be highly variable across countries and cultures, GSK will consider a variety of different measures by which this stipulation may be met, and GSK should be consulted if adequacy of a caregiver situation is in doubt. However, as guidance, the ability for a caregiver to meet his/her expected responsibilities for this study would normally be possible when the caregiver spends no less than 10 hours per week with the subject, divided over multiple days
  • For the purposes of these criteria, QTc B is defined as (QT interval [msec]) / (square root of RR interval [seconds]); and QTc F is defined as (QT interval [msec]) / (cube root of RR interval [seconds])

Exclusion criteria:

  • Subject had a serious adverse experience or clinically significant laboratory abnormality during AVA105640, which in the opinion of the investigator could have been attributable to study medication, and which is ongoing at Visit 1
  • The subject is felt by the investigator to be unsuitable (on the basis of health, compliance, caregiver availability, or for any other reason) for inclusion in the study
  • The subject experienced a significant cardiovascular event during AVA105640 (e.g. intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome [non Q-wave myocardial infarction, Q-wave myocardial infarction, unstable angina] or significant arrhythmia), unless a thorough cardiovascular evaluation has been performed which confirms that the subject does not have congestive heart failure, and is clinically stable
  • Clinical/investigational evidence of congestive heart failure defined by the New York Heart Association (NYHA) criteria (Class I to IV cardiac status) at the time of Visit 1
  • Clinically significant peripheral oedema at the time of Visit 1
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase values >2.5 times the upper limit of normal (ULN), total bilirubin values >1.5 times the ULN, or history of severe hepatobiliary disease (e.g. hepatitis B or C, or cirrhosis, Child-Pugh Class B/C)
  • Subject is an immediate family member or employee of the participating Investigator, of any of the participating site staff, or of GSK
  • In France, a subject is neither affiliated with nor a beneficiary of a social security category
  • In France, a subject has participated in any study using an investigational drug during the previous 30 days (except for participation in AVA105640)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550420

  Hide Study Locations
Locations
United States, California
GSK Investigational Site
Palo Alto, California, United States, 94305
United States, Florida
GSK Investigational Site
Deerfield Beach, Florida, United States, 33064
GSK Investigational Site
Hialeah, Florida, United States, 33016
GSK Investigational Site
Melbourne, Florida, United States, 32901
GSK Investigational Site
Plantation, Florida, United States, 33317
GSK Investigational Site
Tampa, Florida, United States, 33613
United States, Ohio
GSK Investigational Site
Centerville, Ohio, United States, 45459
United States, Oklahoma
GSK Investigational Site
Tulsa, Oklahoma, United States, 74104
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37212
Austria
GSK Investigational Site
Graz-Eggenberg, Austria, A-8020
GSK Investigational Site
Hall in Tirol, Austria, A-6060
Bulgaria
GSK Investigational Site
Plovdiv, Bulgaria, 4000
GSK Investigational Site
Sofia, Bulgaria, 1431
GSK Investigational Site
Sofia, Bulgaria, 1113
GSK Investigational Site
Sofia, Bulgaria, 1527
Chile
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7500710
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7560356
GSK Investigational Site
Viña del Mar, Valparaíso, Chile, 252-0997
China, Guangdong
GSK Investigational Site
Guangzhou, Guangdong, China, 510370
China
GSK Investigational Site
Beijing, China, 100730
GSK Investigational Site
Beijing, China, 100083
GSK Investigational Site
Shanghai, China, 200040
GSK Investigational Site
Shanghai, China, 200025
GSK Investigational Site
Shanghai, China, 200030
GSK Investigational Site
Tianjin, China, 300052
Croatia
GSK Investigational Site
Zagreb, Croatia, 10000
Estonia
GSK Investigational Site
Tallinn, Estonia, 10138
GSK Investigational Site
Tallinn, Estonia, 10614
GSK Investigational Site
Tallinn, Estonia, 10617
GSK Investigational Site
Tartu, Estonia, 51014
Germany
GSK Investigational Site
Ellwangen, Baden-Wuerttemberg, Germany, 73479
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany, 72076
GSK Investigational Site
Guenzburg, Bayern, Germany, 89312
GSK Investigational Site
Muenchen, Bayern, Germany, 80331
GSK Investigational Site
Nuernberg, Bayern, Germany, 90402
GSK Investigational Site
Unterhaching, Bayern, Germany, 82008
GSK Investigational Site
Bad Homburg, Hessen, Germany, 61348
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19053
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19055
GSK Investigational Site
Achim, Niedersachsen, Germany, 28832
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30559
GSK Investigational Site
Baesweiler, Nordrhein-Westfalen, Germany, 52499
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44892
GSK Investigational Site
Duisburg, Nordrhein-Westfalen, Germany, 47051
GSK Investigational Site
Juelich, Nordrhein-Westfalen, Germany, 52428
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50767
GSK Investigational Site
Dresden, Sachsen, Germany, 01097
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
GSK Investigational Site
Berlin, Germany, 12163
GSK Investigational Site
Berlin, Germany, 13507
GSK Investigational Site
Berlin, Germany, 12167
GSK Investigational Site
Hamburg, Germany, 22083
GSK Investigational Site
Hamburg, Germany, 20249
Greece
GSK Investigational Site
Athens, Greece, 115 21
GSK Investigational Site
Thessaloniki, Greece, 57010
Hungary
GSK Investigational Site
Pécs, Hungary, 7623
GSK Investigational Site
Szeged, Hungary, 6725
Korea, Republic of
GSK Investigational Site
Seongnam-si,, Korea, Republic of, 463-707
GSK Investigational Site
Seoul, Korea, Republic of, 143-729
Mexico
GSK Investigational Site
Saltillo, Coahuila, Mexico, 25000
GSK Investigational Site
Monterrey, Nuevo León, Mexico, 64660
GSK Investigational Site
Mexico, Mexico, 14000
New Zealand
GSK Investigational Site
Auckland, New Zealand, 0622
Peru
GSK Investigational Site
Lima, Peru, Lima 13
Philippines
GSK Investigational Site
Pasig City, Philippines, 1600
Puerto Rico
GSK Investigational Site
San Juan, Puerto Rico, 00918
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 117049
GSK Investigational Site
Moscow, Russian Federation, 115522
GSK Investigational Site
St.-Petersburg, Russian Federation, 198103
United Kingdom
GSK Investigational Site
West of Scotland Science Park, Glasgow, United Kingdom, G20 0XA
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00550420     History of Changes
Other Study ID Numbers: AVA102677
Study First Received: October 25, 2007
Last Updated: November 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
open-label extension
tolerability
Alzheimer's disease
Rosiglitazone extended-release (XR)
safety
cognition
BRL-049653

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014