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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00550420




Registration number
NCT00550420
Ethics application status
Date submitted
25/10/2007
Date registered
29/10/2007

Titles & IDs
Public title
Study Of Rosiglitazone XR In Subjects With Mild-to-Moderate Alzheimers
Scientific title
An Open-label Extension to Study AVA105640, to Assess the Long-term Safety and Efficacy of Rosiglitazone (Extended Release Tablets) on Cognition in Subjects With Mild to Moderate Alzheimer's Disease.
Secondary ID [1] 0 0
AVA102677
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rosiglitazone XR

Experimental: Arm 1 - Rosiglitazone XR


Treatment: Drugs: Rosiglitazone XR
experimental drug
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Any Adverse Events (AEs) and Severity of AEs
Timepoint [1] 0 0
Up to Week 82
Secondary outcome [1] 0 0
Number of Participants With Serious AEs and Deaths
Timepoint [1] 0 0
Up to Week 82
Secondary outcome [2] 0 0
Percentage of Participants With AEs of Edema
Timepoint [2] 0 0
Up to 82 Weeks
Secondary outcome [3] 0 0
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Timepoint [3] 0 0
Baseline (Visit 1, W0), W4, W8, W12, W16, W24, W36, W52, W64 and Follow-up (W82)
Secondary outcome [4] 0 0
Change From Baseline in Heart Rate (HR)
Timepoint [4] 0 0
Baseline (Visit 1, W0), W4, W8, W12, W16, W24, W36, W52, W64 and Follow-up (W82)
Secondary outcome [5] 0 0
Number of Participants With Abnormal SBP and DBP at Any Time During Treatment Period
Timepoint [5] 0 0
Up to 82 weeks
Secondary outcome [6] 0 0
Number of Participants With Abnormal HR at Any Time During Treatment Period
Timepoint [6] 0 0
Up to 82 weeks
Secondary outcome [7] 0 0
Change From Baseline in Body Weight (BW)
Timepoint [7] 0 0
Baseline (Visit 1, W0), W4, W8, W12, W16, W24, W36, W52, W64 and Follow-up (W82)
Secondary outcome [8] 0 0
Number of Participants With Abnormal BW at Any Time During Treatment Period
Timepoint [8] 0 0
Baseline (Visit 1, W0) to W 52
Secondary outcome [9] 0 0
Change From Baseline in Non-fasting Measures of Lipid Metabolism Including Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein and Triglycerides at Indicated Timepoints.
Timepoint [9] 0 0
Baseline (Visit 1, W0), W4, W16, W36, W52, W76, and W82
Secondary outcome [10] 0 0
Number of Participants With Hematological Parameters of Potential Clinical Concern
Timepoint [10] 0 0
Up to 82 weeks
Secondary outcome [11] 0 0
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern
Timepoint [11] 0 0
Up to 82 weeks
Secondary outcome [12] 0 0
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) Total Score as a Function of Apolipoprotein E (APOE) 4 Status at W24 and W52
Timepoint [12] 0 0
Baseline (Visit 1, W0), W24 and W52
Secondary outcome [13] 0 0
Mean Clinician Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Score as a Function of APOE 4 Status
Timepoint [13] 0 0
Baseline (Visit 1, W0), W 24 and W 52
Secondary outcome [14] 0 0
Change From Baseline in Mini Mental State Examination (MMSE) Total Score as a Function of APOE 4 Status at W24 and W52
Timepoint [14] 0 0
Baseline (Visit 1, W0), W 24 and W52
Secondary outcome [15] 0 0
Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score as a Function of APOEe 4 Status
Timepoint [15] 0 0
Baseline (Visit 1, W0), W24 and W52
Secondary outcome [16] 0 0
Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score as a Function of APOE 4 Status at W24 and W52
Timepoint [16] 0 0
Baseline (Visit 1, W0), W24 and W52
Secondary outcome [17] 0 0
Change From Baseline in Glycosylated Haemoglobin (HbA1c)
Timepoint [17] 0 0
Baseline (Vsit 1 W0), W12, W24, W36, W52, W76 and Follow-up (W82)

Eligibility
Key inclusion 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])
Minimum age
51 Years
Maximum age
91 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/02/2009
Sample size
Target
Accrual to date
Final
331
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
United States of America
State/province [4] 0 0
Oklahoma
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
Austria
State/province [6] 0 0
Graz-Eggenberg
Country [7] 0 0
Austria
State/province [7] 0 0
Hall in Tirol
Country [8] 0 0
Bulgaria
State/province [8] 0 0
Plovdiv
Country [9] 0 0
Bulgaria
State/province [9] 0 0
Sofia
Country [10] 0 0
Chile
State/province [10] 0 0
Región Metro De Santiago
Country [11] 0 0
Chile
State/province [11] 0 0
Valparaíso
Country [12] 0 0
China
State/province [12] 0 0
Guangdong
Country [13] 0 0
China
State/province [13] 0 0
Beijing
Country [14] 0 0
China
State/province [14] 0 0
Shanghai
Country [15] 0 0
China
State/province [15] 0 0
Tianjin
Country [16] 0 0
Croatia
State/province [16] 0 0
Zagreb
Country [17] 0 0
Estonia
State/province [17] 0 0
Tallinn
Country [18] 0 0
Estonia
State/province [18] 0 0
Tartu
Country [19] 0 0
Germany
State/province [19] 0 0
Baden-Wuerttemberg
Country [20] 0 0
Germany
State/province [20] 0 0
Bayern
Country [21] 0 0
Germany
State/province [21] 0 0
Hessen
Country [22] 0 0
Germany
State/province [22] 0 0
Mecklenburg-Vorpommern
Country [23] 0 0
Germany
State/province [23] 0 0
Niedersachsen
Country [24] 0 0
Germany
State/province [24] 0 0
Nordrhein-Westfalen
Country [25] 0 0
Germany
State/province [25] 0 0
Sachsen
Country [26] 0 0
Germany
State/province [26] 0 0
Berlin
Country [27] 0 0
Germany
State/province [27] 0 0
Hamburg
Country [28] 0 0
Greece
State/province [28] 0 0
Athens
Country [29] 0 0
Greece
State/province [29] 0 0
Thessaloniki
Country [30] 0 0
Hungary
State/province [30] 0 0
Pécs
Country [31] 0 0
Hungary
State/province [31] 0 0
Szeged
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Seongnam-si,
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Seoul
Country [34] 0 0
Mexico
State/province [34] 0 0
Coahuila
Country [35] 0 0
Mexico
State/province [35] 0 0
Nuevo León
Country [36] 0 0
Mexico
State/province [36] 0 0
Mexico
Country [37] 0 0
New Zealand
State/province [37] 0 0
Auckland
Country [38] 0 0
Peru
State/province [38] 0 0
Lima
Country [39] 0 0
Philippines
State/province [39] 0 0
Pasig City
Country [40] 0 0
Puerto Rico
State/province [40] 0 0
San Juan
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Moscow
Country [42] 0 0
Russian Federation
State/province [42] 0 0
St.-Petersburg
Country [43] 0 0
United Kingdom
State/province [43] 0 0
West of Scotland Science Park, Glasgow

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00550420