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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00428090




Registration number
NCT00428090
Ethics application status
Date submitted
25/01/2007
Date registered
29/01/2007

Titles & IDs
Public title
Rosiglitazone (Extended Release Tablets) As Monotherapy In Subjects With Mild To Moderate Alzheimer's Disease
Scientific title
A 24-week, Double-blind, Double-dummy, Randomized, Parallel-group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets), Donepezil, and Placebo as Monotherapy on Cognition and Overall Clinical Response in APOE e4-stratified Subjects With Mild to Moderate Alzheimer's Disease. (REFLECT-1)
Secondary ID [1] 0 0
105640
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

Experimental: Rosiglitazone - XR (extended release) oral tablets

Other: Placebo - Placebo (Double-Dummy to Match)


Treatment: Drugs: Rosiglitazone
XR (extended release) oral tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in Apolipoprotein epsilon4 (APOE e4) Negative Cohort
Timepoint [1] 0 0
Baseline (W0) and W24
Primary outcome [2] 0 0
Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in All Except e4/e4's Cohort
Timepoint [2] 0 0
Baseline (W0) and W24
Primary outcome [3] 0 0
Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in Full Population Cohort
Timepoint [3] 0 0
Baseline (W0) and W24
Primary outcome [4] 0 0
Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in APOE4 Negative Cohort
Timepoint [4] 0 0
Baseline (W0) and W24
Primary outcome [5] 0 0
Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in All Except e4/e4's Cohort
Timepoint [5] 0 0
Baseline (W0) and W24
Primary outcome [6] 0 0
Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in Full Population Cohort
Timepoint [6] 0 0
Baseline (W0) and W24
Secondary outcome [1] 0 0
Change From Baseline (W0) in Mean ADAS-Cog Total Score at W8, W16, W24
Timepoint [1] 0 0
Baseline (W0) and up to W24
Secondary outcome [2] 0 0
Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W8, W16, W24
Timepoint [2] 0 0
Baseline (W0) and up to W24
Secondary outcome [3] 0 0
Change From Baseline (W0) in Mean Neuropsychiatric Inventory (NPI) Total Score at W8, W16, W24
Timepoint [3] 0 0
Baseline (W0) and up to W24
Secondary outcome [4] 0 0
Change From Baseline (W0) in Mean Disability Assessment for Dementia (DAD) Scale Total Score at W8, W16, W24
Timepoint [4] 0 0
Baseline (W0) and up to W24
Secondary outcome [5] 0 0
Change From Baseline (W0) in Mean Short Term Memory Assessment Total Score (ADAS-Cog Q1 Plus Q7) at W8, W16, W24
Timepoint [5] 0 0
Baseline (W0) and up to W24
Secondary outcome [6] 0 0
Change From Baseline (W0) in Mean European Quality of Life -5 Dimensions Proxy Version (EQ-5D Proxy) Total Score at W12, W24 Assessed by Utility
Timepoint [6] 0 0
Baseline (W0) and up to W24
Secondary outcome [7] 0 0
Change From Baseline (W0) in Mean European Quality of Life -5 Dimensions Proxy Version (EQ-5D Proxy) Total Score at W12, W24 Assessed by Thermometer (Visual Analog Scale [VAS])
Timepoint [7] 0 0
Baseline (W0) and up to W24
Secondary outcome [8] 0 0
Time Spent Caring for Basic and Instrumental Activities Resource Utilization in Dementia (RUD) Scale at W12 and W24
Timepoint [8] 0 0
Baseline (W0) and up to W24
Secondary outcome [9] 0 0
Change From Baseline (W0) in Alzheimer's Carer's Quality of Life Instrument (ACQLI) Score at W12 and W24.
Timepoint [9] 0 0
Baseline (W0) and up to W24
Secondary outcome [10] 0 0
Change From Baseline (W0) in Mini Mental State Examination (MMSE) Total Score at W24.
Timepoint [10] 0 0
Baseline (W0) and W24
Secondary outcome [11] 0 0
Change From Baseline (W0) in Glycosylated Hemoglobin (HbA1c) at W24.
Timepoint [11] 0 0
Baseline (W0) and W24
Secondary outcome [12] 0 0
Number of Participants With Adverse Events Defined by Severity
Timepoint [12] 0 0
Up to W24
Secondary outcome [13] 0 0
Number of Participants With Systolic and Diastolic Blood Pressure (SBP and DBP), Heart Rate (HR) and Weight Values of Potential Clinical Concern (PCC) Any Time on Treatment (ATOT).
Timepoint [13] 0 0
Up to W24
Secondary outcome [14] 0 0
Change From Baseline (W0) in 12-lead Electrocardiogram (ECG)
Timepoint [14] 0 0
Baseline (W0) and up to W24
Secondary outcome [15] 0 0
Change From Baseline (W0) in Heart Rate (HR) Measured From 12-lead Electrocardiogram (ECG)
Timepoint [15] 0 0
Baseline (W0) and up to W24
Secondary outcome [16] 0 0
Change From Baseline (W0) in Body Weight
Timepoint [16] 0 0
Baseline (W0) and up to W24
Secondary outcome [17] 0 0
Change From Baseline (W0) in Hemoglobin
Timepoint [17] 0 0
Baseline (W0) and up to W24
Secondary outcome [18] 0 0
Change From Baseline (W0) in Hematocrit
Timepoint [18] 0 0
Baseline (W0) and Up to W24
Secondary outcome [19] 0 0
Change From Baseline (W0) in Periodic HbA1c Assessment
Timepoint [19] 0 0
Baseline (W0) and up to W24
Secondary outcome [20] 0 0
Number of Par. With Hematology Data of Potential Clinical Concern Any Time on Treatment
Timepoint [20] 0 0
Up to W24
Secondary outcome [21] 0 0
Number of Par. With Clinical Chemistry Values of Potential Clinical Concern Any Time on Treatment
Timepoint [21] 0 0
Up to W24

Eligibility
Key inclusion criteria
Inclusion criteria:

* Clinical diagnosis of probable Alzheimer's Disease (AD).
* MMSE score 10 to 23
* Has not taken an approved AD therapy in last 30 days.
* No previous hypersensitivity/intolerance to AChEIs
* Have a regular caregiver.
Minimum age
50 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Diagnosis of vascular dementia.
* Type I or secondary diabetes mellitus.
* Type II diabetes mellitus treated with insulin, sulfonylurea or glipizide.
* History or evidence of congestive heart failure, clinically significant peripheral edema or anemia.
* History of significant psychiatric illness, major depressive disorder or current depression needing initiation of treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/02/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/09/2008
Sample size
Target
Accrual to date
Final
862
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Nevada
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oklahoma
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Wisconsin
Country [17] 0 0
Austria
State/province [17] 0 0
Graz-Eggenberg
Country [18] 0 0
Austria
State/province [18] 0 0
Hall in Tirol
Country [19] 0 0
Austria
State/province [19] 0 0
Linz
Country [20] 0 0
Austria
State/province [20] 0 0
Vienna
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Plovdiv
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Sofia
Country [23] 0 0
Chile
State/province [23] 0 0
Región Metro De Santiago
Country [24] 0 0
Chile
State/province [24] 0 0
Valparaíso
Country [25] 0 0
China
State/province [25] 0 0
Guangdong
Country [26] 0 0
China
State/province [26] 0 0
Beijing
Country [27] 0 0
China
State/province [27] 0 0
Shanghai
Country [28] 0 0
China
State/province [28] 0 0
Tianjin
Country [29] 0 0
Croatia
State/province [29] 0 0
Dubrovnik
Country [30] 0 0
Croatia
State/province [30] 0 0
Zagreb
Country [31] 0 0
Estonia
State/province [31] 0 0
Tallinn
Country [32] 0 0
Estonia
State/province [32] 0 0
Tartu
Country [33] 0 0
Germany
State/province [33] 0 0
Baden-Wuerttemberg
Country [34] 0 0
Germany
State/province [34] 0 0
Bayern
Country [35] 0 0
Germany
State/province [35] 0 0
Hessen
Country [36] 0 0
Germany
State/province [36] 0 0
Mecklenburg-Vorpommern
Country [37] 0 0
Germany
State/province [37] 0 0
Niedersachsen
Country [38] 0 0
Germany
State/province [38] 0 0
Nordrhein-Westfalen
Country [39] 0 0
Germany
State/province [39] 0 0
Sachsen-Anhalt
Country [40] 0 0
Germany
State/province [40] 0 0
Sachsen
Country [41] 0 0
Germany
State/province [41] 0 0
Schleswig-Holstein
Country [42] 0 0
Germany
State/province [42] 0 0
Thueringen
Country [43] 0 0
Germany
State/province [43] 0 0
Berlin
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Germany
State/province [44] 0 0
Hamburg
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Greece
State/province [45] 0 0
Athens
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Greece
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Melissia
Country [47] 0 0
Greece
State/province [47] 0 0
Thessaloniki
Country [48] 0 0
Hungary
State/province [48] 0 0
Budapest
Country [49] 0 0
Hungary
State/province [49] 0 0
Gyula
Country [50] 0 0
Hungary
State/province [50] 0 0
Kaposvár
Country [51] 0 0
Hungary
State/province [51] 0 0
Pécs
Country [52] 0 0
Hungary
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Szeged
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India
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Bangalore
Country [54] 0 0
India
State/province [54] 0 0
Nagpur
Country [55] 0 0
India
State/province [55] 0 0
Tirupati
Country [56] 0 0
Korea, Republic of
State/province [56] 0 0
Seongnam-si,
Country [57] 0 0
Korea, Republic of
State/province [57] 0 0
Seoul
Country [58] 0 0
Mexico
State/province [58] 0 0
Coahuila
Country [59] 0 0
Mexico
State/province [59] 0 0
Nuevo León
Country [60] 0 0
Mexico
State/province [60] 0 0
Mexico
Country [61] 0 0
New Zealand
State/province [61] 0 0
Auckland
Country [62] 0 0
Pakistan
State/province [62] 0 0
Karachi
Country [63] 0 0
Pakistan
State/province [63] 0 0
Lahore
Country [64] 0 0
Peru
State/province [64] 0 0
Lima
Country [65] 0 0
Philippines
State/province [65] 0 0
Pasig City
Country [66] 0 0
Philippines
State/province [66] 0 0
Quezon City
Country [67] 0 0
Puerto Rico
State/province [67] 0 0
Cabo Rojo
Country [68] 0 0
Puerto Rico
State/province [68] 0 0
San Juan
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Moscow
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Russian Federation
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St. Petersburg
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Russian Federation
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St.-Petersburg
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United Kingdom
State/province [72] 0 0
Bradford
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Derriford, Plymouth
Country [74] 0 0
United Kingdom
State/province [74] 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/NCT00428090