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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00348140




Registration number
NCT00348140
Ethics application status
Date submitted
30/06/2006
Date registered
4/07/2006

Titles & IDs
Public title
Rosiglitazone (Extended Release Tablets) As Adjunctive Therapy In Subjects With Mild To Moderate Alzheimer's Disease
Scientific title
A 54 Week, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets) as Adjunctive Therapy to Acetylcholinesterase Inhibitors on Cognition and Overall Clinical Response in APOE4-stratified Subjects With Mild to Moderate Alzheimer's Disease
Secondary ID [1] 0 0
AVA102670
Universal Trial Number (UTN)
Trial acronym
REFLECT-3
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 Extended Release 2mg
Treatment: Drugs - Rosiglitazone Extended Release 8mg
Other interventions - Placebo

Experimental: Arm 1 - Rosiglitazone Extended Release 2mg OD

Experimental: Arm 2 - Rosiglitazone Extended Release 8mg OD

Placebo comparator: Arm 3 - Placebo


Treatment: Drugs: Rosiglitazone Extended Release 2mg
Rosiglitazone Extended Release 2mg OD

Treatment: Drugs: Rosiglitazone Extended Release 8mg
Rosiglitazone Extended Release 8mg OD

Other interventions: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score at Week 48, as a Function of APOE e4 Status in APOE4 Negatives Cohort
Timepoint [1] 0 0
Baseline (Week 0) and Week 48
Primary outcome [2] 0 0
Change From Baseline in ADAS-Cog Total Score at Week 48, as a Function of APOE e4 Status in All Except E4/E4s Cohort
Timepoint [2] 0 0
Baseline (Week 0) and Week 48
Primary outcome [3] 0 0
Change From Baseline in ADAS-Cog Total Score at Week 48, as a Function of APOE e4 Status in Full Population Cohort
Timepoint [3] 0 0
Baseline (Week 0) and Week 48
Primary outcome [4] 0 0
Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score at Week 48, as a Function of APOE e4 Status in APOE4 Negatives Cohort
Timepoint [4] 0 0
Baseline (Week 0) and Week 48
Primary outcome [5] 0 0
Change From Baseline in CDR-SB Score at Week 48, as a Function of APOE e4 Status in All Except E4/E4s Cohort
Timepoint [5] 0 0
Baseline (Week 0) and Week 48
Primary outcome [6] 0 0
Change From Baseline in CDR-SB Score at Week 48, as a Function of APOE e4 Status in Full Population Cohort
Timepoint [6] 0 0
Baseline (Week 0) and Week 48
Secondary outcome [1] 0 0
Change From Baseline in ADAS-Cog Total Score at Weeks 8, 16, 24 and 36
Timepoint [1] 0 0
Baseline (Week 0) and Week 8, 16, 24, 36
Secondary outcome [2] 0 0
Change From Baseline in CDR-SB Score at Weeks 12, 24 and 36
Timepoint [2] 0 0
Baseline (Week 0) and Week 12, 24, 36
Secondary outcome [3] 0 0
Change From Screening in Mini Mental State Examination (MMSE) Total Score
Timepoint [3] 0 0
Screening (Week -4) and Week 48
Secondary outcome [4] 0 0
Change From Baseline in Disability Assessment for Dementia (DAD) Total Score
Timepoint [4] 0 0
Baseline (Week 0) and Week 8, 16, 24, 48
Secondary outcome [5] 0 0
Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score
Timepoint [5] 0 0
Baseline (Week 0) and Week 8, 16, 24, 48
Secondary outcome [6] 0 0
Change From Baseline in Domains of the Resource Utilization in Dementia Scale (RUD)- Q1 and Q2 Caregiver Hours
Timepoint [6] 0 0
Baseline (Week 0) and Week 12, 24, 36, 48
Secondary outcome [7] 0 0
Change From Baseline in European Quality of Life -5 Dimensions (EQ-5D) Scale Total Score- Thermometer Score
Timepoint [7] 0 0
Baseline (Week 0) and Week 12, 36, 48
Secondary outcome [8] 0 0
Change From Baseline in EQ-5D Scale Total Score- Utility Score
Timepoint [8] 0 0
Baseline (Week 0) and Week 12, 36, 48
Secondary outcome [9] 0 0
Change From Baseline in Alzheimer's Carer's Quality of Life Instrument (ACQLI) Score
Timepoint [9] 0 0
Baseline (Week 0) and Week 12, 36, 48
Secondary outcome [10] 0 0
Change in ADAS-Cog Total Score for Observed Cases at Week 54 Compared to Week 48
Timepoint [10] 0 0
Week 48 and Week 54
Secondary outcome [11] 0 0
Change in CDR-SB Total Score for Observed Cases at Week 54 Compared to Week 48
Timepoint [11] 0 0
Week 48 and Week 54
Secondary outcome [12] 0 0
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 48
Timepoint [12] 0 0
Baseline (Week 0) and Week 48
Secondary outcome [13] 0 0
Number of Participants With On-treatment Adverse Events (AEs), Serious Adverse Events (SAEs) and Severity of AEs
Timepoint [13] 0 0
Upto Week 48
Secondary outcome [14] 0 0
Number of Participants With Change From Baseline in Vital Signs of Clinical Concern at Any Time on Treatment- Weight
Timepoint [14] 0 0
Upto Week 54
Secondary outcome [15] 0 0
Number of Participants With Change From Baseline in Vital Signs of Clinical Concern at Any Time on Treatment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Timepoint [15] 0 0
Upto Week 54
Secondary outcome [16] 0 0
Number of Participants With Change From Baseline in Vital Signs of Clinical Concern at Any Time on Treatment- Heart Rate (HR)
Timepoint [16] 0 0
Upto Week 54
Secondary outcome [17] 0 0
Change From Baseline in Weight
Timepoint [17] 0 0
Baseline (Week 0) and Weeks 4, 8, 12, 16, 24, 36, 48, 54
Secondary outcome [18] 0 0
Change From Baseline in Hemoglobin
Timepoint [18] 0 0
Baseline (Week 0) and Weeks 4, 16, 36, 48
Secondary outcome [19] 0 0
Change From Baseline in Hematocrit
Timepoint [19] 0 0
Baseline (Week 0) and Weeks 4, 16, 36, 48
Secondary outcome [20] 0 0
Any Time on Treatment Differences in Frequencies of Hematology Data Outside the Reference Range
Timepoint [20] 0 0
Up to Week 48
Secondary outcome [21] 0 0
Any Time on Treatment Differences in Frequencies of Clinical Chemistry Data Outside the Reference Range
Timepoint [21] 0 0
Upto Week 48
Secondary outcome [22] 0 0
Changes From Baseline in Electrocardiogram (ECG) Parameters- HR
Timepoint [22] 0 0
Baseline (Week 0) and Weeks 4, 8, 16, 24, 36, 48, 54
Secondary outcome [23] 0 0
Changes From Baseline in ECG Parameters- RR Interval, QT Interval, QTcB, QTcF, PR Interval and QRS Duration
Timepoint [23] 0 0
Baseline (Week 0) and Weeks 4, 8, 16, 24, 36, 48, 54
Secondary outcome [24] 0 0
Change From Baseline in HbA1c up to Week 54
Timepoint [24] 0 0
Baseline (Week 0) and Weeks 12, 24, 36, 48, 54
Secondary outcome [25] 0 0
Change From Baseline in Short Term Memory Assessment
Timepoint [25] 0 0
Baseline (Week 0) and upto Week 48

Eligibility
Key inclusion criteria
A subject will be eligible for inclusion in this study only if all of the following criteria apply:

* Male or female subject with a clinical diagnosis of probable Alzheimer's disease in accordance with NINCDS-ADRDA criteria (Appendix 2).

(Note: National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and Alzheimer's Disease and Related Disorders Association (ADRDA).)

* Subject has mild to moderate Alzheimer's disease as defined by a MMSE score 10 to 26 inclusive at Screening.
* Hachinski Ischemia Score = 4 at Screening (See Appendix 3).
* Age =50 and =90 years.
* At least 6 months of ongoing acetylcholinesterase inhibitor therapy for Alzheimer's disease, with stable dosing for at least the last 2 months (and with no intent to change for the duration of the study).
* Current use of medication is in accordance with the criteria listed in Table 2 (Permitted Medications, Section 8.1).
* Female subjects must be post-menopausal (i.e. >1 year without menstrual period), surgically sterile, or agree to use adequate method of contraception (Appendix 4) for the duration of the study. Female subjects who are pre-menopausal or who have been post-menopausal for <1 year must undertake pregnancy testing (urine test) at Visit 1, which must be negative.
* Brain CT or MRI scan performed within the past 12 months or at Screening, showing no evidence of any other potential cause of dementia other than Alzheimer's disease.

(Note: Questionable CT or MRI scans should be discussed with the medical monitor, using central imaging guidelines.)

* Neurological exam without focal changes (excluding changes attributable to AD or peripheral trauma).
* Subject has the ability to comply with procedures for cognitive and other testing.
* 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.

(Note: 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 behavior, 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.)

* Subject 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.

(Note: Consent by legally acceptable representative is allowed where this is in accordance with local laws, regulations and ethics committee policy.)

* Caregiver has provided full written informed consent on his/her own behalf prior to the performance of any protocol-specified procedure.
* Subjects considered for enrolment 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).

(Note: 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
50 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A subject will not be eligible for inclusion in this study if any of the following criteria apply:

* Diagnosis of possible, probable, or definite vascular dementia in accordance with NINDS-AIREN criteria (Appendix 5).

(Note: National Institute of Neurological Disorders and Stroke (NINDS) and Association Internationale pour la Recherche et l'Enseignement en Neurosciences (AIREN).)

* History or evidence of any other CNS disorder that could be interpreted as a cause of dementia: e.g. cerebrovascular disease (stroke, hemorrhage), structural abnormality, epilepsy, infectious or inflammatory/demyelinating CNS conditions, Parkinson's disease.
* Evidence of the following disorders: current vitamin B12 deficiency, positive syphilis serology, or active thyroid dysfunction (particularly that suggestive of hypothyroidism), including abnormally high or low serum levels of thyroid stimulating hormone (TSH), that are clinically significant in the opinion of the investigator.

(Note: Testing is required for each parameter only when no result is available from previous 12 months.)

* History of Type 1 diabetes mellitus or secondary diabetes mellitus.
* Type 2 diabetes mellitus where the subject is being treated with insulin, a PPAR? agonist, or an insulin secretagogue (e.g. a sulfonylurea or glitinide).
* Any patient with an HbA1c =8.5%. (See Section 6.3.8.4 for Safety Measures for Enrolled Subjects with Type 2 Diabetes Mellitus.)
* History or clinical/investigational evidence of congestive heart failure defined by the New York Heart Association criteria (Class I to IV cardiac status; Appendix 6).
* History of cardiovascular event within the last 6 months (i.e. intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome [non Q-wave myocardial infarction, Q-wave myocardial infarction, unstable angina] or significant arrhythmia; or major intervention (e.g. cardiac surgery or angiography plus stenting) scheduled).
* History of significant psychiatric illness such as schizophrenia or bipolar affective disorder that in the opinion of the Investigator would interfere with participation in the study, major depressive disorder (according to DSM-IV) in the past year, or current active depression requiring initiation of treatment.

(Note: If not currently treated, but active depression is suspected, the Cornell Scale for Depression in Dementia (CSDD, Appendix 7) can be used by the Investigator as a guide for deciding whether a prospective subject requires treatment. If the subject has a CSDD score >7, the Investigator should decide if the subject has depression in need of prescribed medication, and a CSDD >12 is considered a strong indicator that treatment is needed. Subjects will be allowed to re-screen after their depression has been adequately managed for >3 months.)

* History or presence of gastro-intestinal, hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs, or any other clinically relevant abnormality, medical or psychiatric condition, which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
* Clinically significant peripheral edema at the time of screening.
* Current or recent drug or alcohol abuse or dependence (defined by DSM-IV criteria for substance-related disorders), or recent or remote history of the same if that could be a contributing factor to the dementia.
* Systolic blood pressure >165 or <90 mmHg or diastolic blood pressure >95 or <60 mmHg at the time of screening.
* Clinically significant anemia (i.e. hemoglobin <11 g/dL for males or <10 g/dL for females) or presence of hemoglobinopathies which would prevent accurate assessment of HbA1c.
* Abnormal kidney function tests (>1.5 times the upper limit of normal (ULN)).
* ALT, AST, or alkaline phosphatase values >2.5 times the 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).

(Note: For subjects with a diagnosis of Gilberts Syndrome and an isolated increase in total bilirubin >1.5 ULN, fractionation should be performed. If all of the following conditions are met, the patient may enter or remain in the study, even if total bilirubin >1.5 ULN:

* an elevated unconjugated (indirect) bilirubin;
* the percentage of direct bilirubin <35%;
* ALT, AST, and alkaline phosphatase <2.5 ULN if subject is in screening (<2.0 ULN for Canadian subjects only), or =3 ULN if subject is already randomized into the study)
* History of a bone marrow transplant.
* Subject is unable (with assistance, if appropriate) to take study medication as prescribed throughout the study or is at risk of non-compliance with study medication or procedures.
* 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.
* The French subject has participated in any study using an investigational drug during the previous 30 days or 5 half-lives (whichever is longer).
* Cognitive tasks prescribed for cognitive rehabilitation and performed under medical supervision are prohibited for 6 months prior to Screening, as well as for the duration of the study.

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 administering the treatment/s
The people assessing the outcomes
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
12/07/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/03/2009
Sample size
Target
Accrual to date
Final
1468
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Hornsby
Recruitment hospital [2] 0 0
GSK Investigational Site - Randwick
Recruitment hospital [3] 0 0
GSK Investigational Site - Auchenflower
Recruitment hospital [4] 0 0
GSK Investigational Site - Chermside
Recruitment hospital [5] 0 0
GSK Investigational Site - Kippa Ring
Recruitment hospital [6] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [7] 0 0
GSK Investigational Site - Woodville
Recruitment hospital [8] 0 0
GSK Investigational Site - Cheltenham
Recruitment hospital [9] 0 0
GSK Investigational Site - Heidelberg West
Recruitment hospital [10] 0 0
GSK Investigational Site - Kew
Recruitment hospital [11] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2077 - Hornsby
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
4032 - Chermside
Recruitment postcode(s) [5] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
5011 - Woodville
Recruitment postcode(s) [8] 0 0
3192 - Cheltenham
Recruitment postcode(s) [9] 0 0
3084 - Heidelberg West
Recruitment postcode(s) [10] 0 0
3101 - Kew
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
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
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
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
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Illinois
Country [8] 0 0
United States of America
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Massachusetts
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New Jersey
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New York
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North Carolina
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Ohio
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United States of America
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Oklahoma
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Pennsylvania
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Rhode Island
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South Carolina
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United States of America
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Texas
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Utah
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Virginia
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United States of America
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Washington
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United States of America
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Wisconsin
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Belgium
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Bruxelles
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Belgium
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Kortrijk
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Belgium
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Leuven
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Belgium
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Woluwe-Saint-Lambert
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Bulgaria
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Sofia
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Bulgaria
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Varna
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Canada
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British Columbia
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Canada
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New Brunswick
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Québec
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Czechia
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Olomouc
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Czechia
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Praha 10
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Czechia
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Praha 8
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Czechia
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Trutnov
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Finland
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Helsinki
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Finland
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Joensuu
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Finland
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Kuopio
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France
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Bordeaux
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France
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La Chapelle sur Erdre
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France
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La Seyne sur Mer
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France
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Lille
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France
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Limoges
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France
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Metz
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France
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Nantes
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France
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Paris
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France
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Sautron
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France
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Toulon
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France
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Toulouse
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Valence
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Germany
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Baden-Wuerttemberg
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Germany
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Bayern
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Germany
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Brandenburg
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Germany
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Hessen
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Germany
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Sachsen
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Germany
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Thueringen
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Germany
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Berlin
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Hong Kong
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Hong Kong
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Hong Kong
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Shatin
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Korea, Republic of
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Seongnam-si,
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Korea, Republic of
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Seoul
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Malaysia
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Bandar Tun Razak, Cheras
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Malaysia
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Ipoh
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Malaysia
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Kelantan
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Netherlands
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Alkmaar
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Netherlands
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Blaricum
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Netherlands
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Den Bosch
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Netherlands
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Den Haag
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Netherlands
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Hengelo
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Netherlands
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Hilversum
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Philippines
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Manila
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Philippines
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Pasig City
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Poland
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Bydgoszcz
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Poland
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Krakow
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Poland
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Torun
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Poland
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Warsaw
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Singapore
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Singapore
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Slovakia
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Bratislava
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Slovakia
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Kosice
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Slovenia
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Ljubljana
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Slovenia
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Šempeter
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South Africa
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Loeventstein
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South Africa
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Oakdale
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South Africa
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Richards Bay
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South Africa
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Rosebank
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South Africa
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Somerset West
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South Africa
State/province [89] 0 0
Waverley, Bloemfontein
Country [90] 0 0
South Africa
State/province [90] 0 0
Willows, X14, Pretoria
Country [91] 0 0
Spain
State/province [91] 0 0
Baracaldo/Vizcaya
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Spain
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Barcelona
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Spain
State/province [93] 0 0
Palma de Mallorca
Country [94] 0 0
Spain
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Tarrasa, Barcelona
Country [95] 0 0
Sweden
State/province [95] 0 0
Falköping
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Sweden
State/province [96] 0 0
Jönköping
Country [97] 0 0
Sweden
State/province [97] 0 0
Kalix
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Sweden
State/province [98] 0 0
Mölndal
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Sweden
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Sundsvall
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Sweden
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Umeå
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United Kingdom
State/province [101] 0 0
Lancashire
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United Kingdom
State/province [102] 0 0
Bradford
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United Kingdom
State/province [103] 0 0
Liverpool
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United Kingdom
State/province [104] 0 0
Stirling
Country [105] 0 0
United Kingdom
State/province [105] 0 0
West End, Southampton
Country [106] 0 0
United Kingdom
State/province [106] 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/NCT00348140