REFLECT-2

CompletedPhase NAResults posted

Rosiglitazone (Extended Release Tablets) As Adjunctive Therapy For Subjects With Mild To Moderate Alzheimer's Disease

A 54-week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets) as Adjunctive Therapy to Donepezil on Cognition and Overall Clinical Response in APOE ε4-stratified Subjects With Mild to Moderate Alzheimer's Disease.

Lead sponsor

GlaxoSmithKline

Assets

Donepezil / Rosiglitazone

Listed sites

249

Recruiting sites

Enrollment

1,496

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE 10-26•Study partner/caregiver required

Primary endpoints

•ADAS-Cog•Clinical Dementia Rating-Sum of Boxes (CDR-SB)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDAVA102672

NCT IDNCT00348309

Timeline

Milestones

Study first posted2006-07-04estimated

Study start2006-07-06

Primary completion2009-01-01actual

Study completion2009-01-28actual

Last update posted2017-11-28actual

Results first posted2017-11-28actual

Assets

Drug assets

Donepezil Rosiglitazone

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

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.

(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.

•Age ≥50 and ≤90 years.

•At least 6 months of ongoing donepezil 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,).

•Female subjects must be post-menopausal (i.e. >1 year without menstrual period), surgically sterile, or agree to use adequate method of contraception 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]).)

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.

(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 PPARγ agonist, or an insulin secretagogue (e.g. a sulfonylurea or glitinide).

•Any patient with an HbA1c ≥8.5%. (See Section 6.3.7.4 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;).

•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) 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 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.

Endpoints (44)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Other (unclassified)

Behavior / neuropsychiatric

Caregiver / quality of life

Function / daily living

Safety / tolerability / PK

Other clinical outcomes

Global cognition

16 endpoints

Primary/protocol endpoint

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score at Week 48

Time frame:Baseline (Week 0) and Week 48

ADAS-Cog

change from baseline, improvement

Primary/protocol endpoint

Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) at Week 48 for APOE E4

Time frame:Baseline (Week 0) and Week 48

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Primary/registry result

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score at Week 48

Time frame:Baseline (Week 0) and Week 48

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on a scale	Standard error
PlaceboAPOE4 negativesn=153 Participants	2.9	0.54
All except E4/E4sn=317 Participants	3.1	0.36
Full populationsn=356 Participants	3.4	0.35
2mg Rosiglitazone Extended ReleaseAPOE4 negativesn=172 Participants	1.6	0.42
All except E4/E4sn=350 Participants	2.1	0.29
Full populationsn=391 Participants	2.4	0.30
8mg Rosiglitazone Extended ReleaseAPOE4 negativesn=141 Participants	2.7	0.56
All except E4/E4sn=285 Participants	3.1	0.37
Full populationsn=333 Participants	3.2	0.35

Mean Difference (Final Values)-1.395% CI-2.7 - -0.0p0.049Mixed Models Analysis

Mean Difference (Final Values)-0.295% CI-1.7 - 1.3p0.808Mixed Models Analysis

Mean Difference (Final Values)-1.095% CI-1.9 - -0.1p0.035Mixed Models Analysis

Mean Difference (Final Values)0.095% CI-1.0 - 1.0p0.999Mixed Models Analysis

Mean Difference (Final Values)-1.095% CI-1.9 - -0.2p0.020Mixed Models Analysis

Mean Difference (Final Values)-0.295% CI-1.2 - 0.7p0.661Mixed Models Analysis

Primary/registry result

Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) at Week 48 for APOE E4

Time frame:Baseline (Week 0) and Week 48

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on a scale	Standard error
PlaceboAPOE4 negativesn=146 Participants	1.3	0.21
All except E4/E4sn=309 Participants	1.5	0.14
Full populationn=347 Participants	1.6	0.14
2mg Rosiglitazone Extended ReleaseAPOE4 negativesn=169 Participants	0.8	0.16
All except E4/E4sn=343 Participants	1.0	0.12
Full populationn=384 Participants	1.0	0.12
8mg Rosiglitazone Extended ReleaseAPOE4 negativesn=139 Participants	1.5	0.20
All except E4/E4sn=283 Participants	1.7	0.14
Full populationn=331 Participants	1.7	0.13

Mean Difference (Final Values)-0.595% CI-1.0 - 0.0p=0.056Mixed Models Analysis

Mean Difference (Final Values)0.295% CI-0.4 - 0.7p=0.587Mixed Models Analysis

Mean Difference (Final Values)-0.595% CI-0.9 - -0.2p=0.004Mixed Models Analysis

Mean Difference (Final Values)0.295% CI-0.2 - 0.6p=0.402Mixed Models Analysis

Mean Difference (Final Values)-0.595% CI-0.9 - -0.2p=0.002Mixed Models Analysis

Mean Difference (Final Values)0.195% CI-0.2 - 0.5p=0.478Mixed Models Analysis

Secondary/protocol endpoint

Change From Screening in Mini Mental State Examination (MMSE) Total Score

Time frame:Screening (Week -4) and Week 48

Mini-Mental State Examination (MMSE)

concentration, descriptive

Secondary/protocol endpoint

Change From Baseline in ADAS-Cog Total Score for Observed Cases at Weeks 8, 16, 24, 36 and 48

Time frame:Baseline (Week 0), Week 8, 16, 24, 36 and 48

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in CDR-SB Score for Observed Cases at Weeks 12, 24, 36 and 48

Time frame:Baseline (Week 0), Week 12, 24, 36 and 48

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Change in ADAS-Cog Total Score for Observed Cases at Week 54 Compared to Week 48

Time frame:Week 48 and 54

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change in CDR-SB Total Score at Week 54 Compared to Week 48

Time frame:Week 48 and 54

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Short Term Memory Assessment Score

Time frame:Baseline (Week 0), Week 8, 16, 24, 36, 48 and 56

ADAS-Cog

change from baseline, improvement

Secondary/registry result

Change From Screening in Mini Mental State Examination (MMSE) Total Score

Time frame:Screening (Week -4) and Week 48

Mini-Mental State Examination (MMSE)

concentration, descriptive

Posted result

Group	Value (least_squares_mean), Score on a scale	Standard error
Placebon=348 Participants	-1.6	0.21
2mg Rosiglitazone Extended Releasen=388 Participants	-1.6	0.20
8mg Rosiglitazone Extended Releasen=335 Participants	-1.7	0.21

Mean Difference (Final Values)0.095% CI-0.5 - 0.6p0.870ANCOVA

Mean Difference (Final Values)-0.195% CI-0.7 - 0.4p0.617ANCOVA

Secondary/registry result

Change From Baseline in ADAS-Cog Total Score for Observed Cases at Weeks 8, 16, 24, 36 and 48

Time frame:Baseline (Week 0), Week 8, 16, 24, 36 and 48

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard deviation
PlaceboWeek 8n=435 Participants	-0.2	4.21
Week 16n=422 Participants	-0.1	5.09
Week 24n=404 Participants	1.0	5.86
Week 36n=378 Participants	1.8	6.08
Week 48n=358 Participants	2.9	6.85
2mg Rosiglitazone Extended ReleaseWeek 8n=457 Participants	-0.6	4.57
Week 16n=441 Participants	-0.5	4.76
Week 24n=425 Participants	-0.2	5.17
Week 36n=402 Participants	1.3	5.79
Week 48n=393 Participants	2.1	6.25
8mg Rosiglitazone Extended ReleaseWeek 8n=437 Participants	-0.2	4.44
Week 16n=411 Participants	0.1	5.13
Week 24n=386 Participants	0.8	5.66
Week 36n=362 Participants	2.2	6.40
Week 48n=333 Participants	2.6	6.76

Mean Difference (Final Values)-0.795% CI-1.6 - 0.2p0.105ANCOVA

Mean Difference (Final Values)-0.395% CI-1.3 - 0.6p0.483ANCOVA

Secondary/registry result

Change From Baseline in CDR-SB Score for Observed Cases at Weeks 12, 24, 36 and 48

Time frame:Baseline (Week 0), Week 12, 24, 36 and 48

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard deviation
PlaceboWeek 12n=423 Participants	0.4	1.55
Week 24n=402 Participants	0.7	2.01
Week 36n=374 Participants	1.0	2.26
Week 48n=349 Participants	1.5	2.68
2mg Rosiglitazone Extended ReleaseWeek 12n=446 Participants	0.3	1.36
Week 24n=421 Participants	0.5	1.67
Week 36n=400 Participants	0.7	2.06
Week 48n=385 Participants	1.0	2.28
8mg Rosiglitazone Extended ReleaseWeek 12n=414 Participants	0.3	1.40
Week 24n=382 Participants	0.8	1.83
Week 36n=357 Participants	1.2	2.30
Week 48n=331 Participants	1.6	2.56

Mean Difference (Final Values)-0.595% CI-0.9 - -0.2p0.004ANCOVA

Mean Difference (Final Values)0.195% CI-0.3 - 0.5p0.554ANCOVA

Secondary/registry result

Change in ADAS-Cog Total Score for Observed Cases at Week 54 Compared to Week 48

Time frame:Week 48 and 54

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on a scale	Standard error
Placebon=332 Participants	0.7	0.28
2mg Rosiglitazone Extended Releasen=366 Participants	1.1	0.27
8mg Rosiglitazone Extended Releasen=305 Participants	1.1	0.29

Mean Difference (Final Values)0.495% CI-0.3 - 1.1p0.292ANCOVA

Mean Difference (Final Values)0.495% CI-0.3 - 1.1p0.297ANCOVA

Secondary/registry result

Change in CDR-SB Total Score at Week 54 Compared to Week 48

Time frame:Week 48 and 54

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on a scale	Standard error
Placebon=328 Participants	0.2	0.07
2mg Rosiglitazone Extended Releasen=364 Participants	0.2	0.07
8mg Rosiglitazone Extended Releasen=302 Participants	0.1	0.07

Mean Difference (Final Values)0.095% CI-0.2 - 0.1p0.598ANCOVA

Mean Difference (Final Values)-0.295% CI-0.4 - 0.0p0.073ANCOVA

Secondary/registry result

Mean Change From Baseline in Short Term Memory Assessment Score

Time frame:Baseline (Week 0), Week 8, 16, 24, 36, 48 and 56

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard deviation
PlaceboWeek 8n=430 Participants	-0.3	2.71
Week 16n=416 Participants	-0.4	2.93
Week 24n=402 Participants	0.1	2.96
Week 36n=372 Participants	0.4	2.79
Week 48n=356 Participants	0.6	3.01
Week 54n=333 Participants	1.1	2.96
2mg Rosiglitazone Extended ReleaseWeek 8n=455 Participants	-0.4	3.03
Week 16n=433 Participants	-0.7	2.92
Week 24n=418 Participants	-0.4	3.03
Week 36n=393 Participants	0.3	3.18
Week 48n=383 Participants	0.3	3.07
Week 54n=367 Participants	0.8	3.10
8mg Rosiglitazone Extended ReleaseWeek 8n=431 Participants	-0.3	2.76
Week 16n=404 Participants	-0.4	3.07
Week 24n=377 Participants	-0.1	3.06
Week 36n=358 Participants	0.7	3.04
Week 48n=329 Participants	0.4	3.06
Week 54n=305 Participants	0.9	3.17

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score

Time frame:Baseline (Week 0), Week 8, 16, 24 and 48

change from baseline, improvement

Secondary/registry result

Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score

Time frame:Baseline (Week 0), Week 8, 16, 24 and 48

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Scores on a scale	Standard error
PlaceboAt Week 8n=436 Participants	0.1	0.56
At Week 16n=436 Participants	-1.6	0.62
At Week 24n=436 Participants	-3.5	0.69
At Week 48n=436 Participants	-7.8	0.82
2mg Rosiglitazone Extended ReleaseAt Week 8n=458 Participants	-0.5	0.48
At Week 16n=458 Participants	-1.6	0.59
At Week 24n=458 Participants	-2.2	0.64
At Week 48n=458 Participants	-5.7	0.78
8mg Rosiglitazone Extended ReleaseAt Week 8n=441 Participants	-1.1	0.47
At Week 16n=441 Participants	-2.1	0.56
At Week 24n=441 Participants	-3.3	0.69
At Week 48n=441 Participants	-8.4	0.84

Mean Difference (Final Values)-0.695% CI-2.0 - 0.7p=0.340Mixed Models Analysis

Mean Difference (Final Values)-1.295% CI-2.5 - 0.1p=0.079Mixed Models Analysis

Mean Difference (Final Values)-0.195% CI-1.7 - 1.5p=0.910Mixed Models Analysis

Mean Difference (Final Values)-0.595% CI-2.1 - 1.0p0.521Mixed Models Analysis

Mean Difference (Final Values)1.395% CI-0.5 - 3.0p=0.154Mixed Models Analysis

Mean Difference (Final Values)0.295% CI-1.6 - 2.0p=0.836Mixed Models Analysis

Mean Difference (Final Values)2.195% CI-0.1 - 4.2p0.061Mixed Models Analysis

Mean Difference (Final Values)-0.795% CI-2.9 - 1.6p=0.566Mixed Models Analysis

Behavior / neuropsychiatric

4 endpoints

Secondary/protocol endpoint

Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score

Time frame:Baseline (Week 0), Week 8, 16, 24 and 48

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in European Quality of Life-5 Dimensions Proxy Version (EQ-5D Proxy) Scale Total Score Assessed by Thermometer (Visual Analog Scale [VAS]) and Utility

Time frame:Baseline (Week 0), Week 12, 36 and 48

change from baseline, improvement

Secondary/registry result

Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score

Time frame:Baseline (Week 0), Week 8, 16, 24 and 48

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on a scale	Standard error
PlaceboAt Week 8n=440 Participants	-0.3	0.39
At Week 16n=425 Participants	-0.3	0.43
At Week 24n=411 Participants	0.4	0.47
At Week 48n=359 Participants	1.6	0.61
2mg Rosiglitazone Extended ReleaseAt Week 8n=458 Participants	-0.7	0.32
At Week 16n=442 Participants	-0.6	0.36
At Week 24n=425 Participants	-0.2	0.39
At Week 48n=395 Participants	0.1	0.44
8mg Rosiglitazone Extended ReleaseAt Week 8n=442 Participants	-0.3	0.39
At Week 16n=415 Participants	0.1	0.43
At Week 24n=390 Participants	0.2	0.48
At Week 48n=345 Participants	1.8	0.55

Mean Difference (Final Values)-0.495% CI-1.3 - 0.5p=0.414Mixed Models Analysis

Mean Difference (Final Values)0.095% CI-1.0 - 1.1p0.931Mixed Models Analysis

Mean Difference (Final Values)-0.495% CI-1.4 - 0.7p0.485Mixed Models Analysis

Mean Difference (Final Values)0.395% CI-0.8 - 1.5p0.550Mixed Models Analysis

Mean Difference (Final Values)-0.695% CI-1.8 - 0.5p0.264Mixed Models Analysis

Mean Difference (Final Values)-0.295% CI-1.5 - 1.0p0.732Mixed Models Analysis

Mean Difference (Final Values)-1.595% CI-2.9 - -0.0p0.043Mixed Models Analysis

Mean Difference (Final Values)0.295% CI-1.4 - 1.8p0.814Mixed Models Analysis

Secondary/registry result

Change From Baseline in European Quality of Life-5 Dimensions Proxy Version (EQ-5D Proxy) Scale Total Score Assessed by Thermometer (Visual Analog Scale [VAS]) and Utility

Time frame:Baseline (Week 0), Week 12, 36 and 48

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on a scale	Standard error
PlaceboThermometer: Week 12n=425 Participants	0.5	0.84
Thermometer: Week 36n=381 Participants	0.8	0.95
Thermometer: Week 48n=352 Participants	-1.5	1.05
Utility: Week 12n=425 Participants	0.01	0.009
Utility: Week 36n=381 Participants	-0.02	0.011
Utility: Week 48n=351 Participants	-0.04	0.012
2mg Rosiglitazone Extended ReleaseThermometer: Week 12n=449 Participants	0.3	0.82
Thermometer: Week 36n=404 Participants	-1.6	0.97
Thermometer: Week 48n=389 Participants	-0.3	0.96
Utility: Week 12n=448 Participants	0.02	0.009
Utility: Week 36n=403 Participants	-0.01	0.010
Utility: Week 48n=389 Participants	-0.02	0.011
8mg Rosiglitazone Extended ReleaseThermometer: Week 12n=413 Participants	-0.5	0.94
Thermometer: Week 36n=362 Participants	-2.1	1.03
Thermometer: Week 48n=337 Participants	-2.4	1.08
Utility: Week 12n=414 Participants	-0.01	0.010
Utility: Week 36n=363 Participants	-0.04	0.012
Utility: Week 48n=337 Participants	-0.05	0.013

Mean Difference (Final Values)-0.195% CI-2.3 - 2.0p0.914Mixed Models Analysis

Mean Difference (Final Values)-1.095% CI-3.3 - 1.4p0.415Mixed Models Analysis

Mean Difference (Final Values)-2.495% CI-4.9 - 0.1p0.063Mixed Models Analysis

Mean Difference (Final Values)-2.995% CI-5.6 - -0.3p0.030Mixed Models Analysis

Mean Difference (Final Values)1.295% CI-1.5 - 3.8p0.392Mixed Models Analysis

Mean Difference (Final Values)-0.995% CI-3.7 - 2.0p0.557Mixed Models Analysis

Mean Difference (Final Values)0.0195% CI-0.01 - 0.03p0.320Mixed Models Analysis

Mean Difference (Final Values)-0.0295% CI-0.04 - 0.01p0.180Mixed Models Analysis

Mean Difference (Final Values)0.0195% CI-0.02 - 0.04p0.498Mixed Models Analysis

Mean Difference (Final Values)-0.0395% CI-0.06 - 0.00p0.081Mixed Models Analysis

Mean Difference (Final Values)0.0395% CI-0.00 - 0.06p0.077Mixed Models Analysis

Mean Difference (Final Values)-0.0195% CI-0.04 - 0.03p0.640Mixed Models Analysis

Caregiver / quality of life

4 endpoints

Secondary/protocol endpoint

Change From Baseline in the Domains of the Resource Utilization in Dementia Scale (RUD)

Time frame:Baseline (Week 0), Week 12, 24, 36 and 48

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Alzheimer's Carer Quality of Life Instrument (ACQLI) Total Score

Time frame:Baseline (Week 0), Week 12, 36 and 48

change from baseline, improvement

Secondary/registry result

Change From Baseline in the Domains of the Resource Utilization in Dementia Scale (RUD)

Time frame:Baseline (Week 0), Week 12, 24, 36 and 48

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), hours	Standard error
PlaceboQ1: Week 12n=386 Participants	1.6	2.25
Q1: Week 24n=386 Participants	10.7	3.52
Q1: Week 36n=342 Participants	16.3	3.60
Q1: Week 48n=320 Participants	21.7	4.16
Q2: Week 12n=171 Participants	-6.4	4.64
Q2: Week 24n=162 Participants	0.3	4.89
Q2: Week 36n=153 Participants	5.0	5.34
Q2: Week 48n=139 Participants	10.8	5.51
2mg Rosiglitazone Extended ReleaseQ1: Week 12n=408 Participants	2.4	2.50
Q1: Week 24n=380 Participants	3.4	1.84
Q1: Week 36n=361 Participants	10.0	3.43
Q1: Week 48n=351 Participants	17.0	4.17
Q2: Week 12n=183 Participants	2.4	4.16
Q2: Week 24n=170 Participants	1.6	4.17
Q2: Week 36n=162 Participants	4.6	4.44
Q2: Week 48n=157 Participants	8.4	4.88
8mg Rosiglitazone Extended ReleaseQ1: Week 12n=379 Participants	-0.1	3.18
Q1: Week 24n=347 Participants	7.0	4.06
Q1: Week 36n=327 Participants	15.2	4.95
Q1: Week 48n=310 Participants	18.1	4.72
Q2: Week 12n=162 Participants	1.5	4.50
Q2: Week 24n=150 Participants	6.5	4.88
Q2: Week 36n=141 Participants	13.3	5.35
Q2: Week 48n=137 Participants	27.0	6.24

Mean Difference (Final Values)0.895% CI-5.2 - 6.9p0.789Mixed Models Analysis

Week 12 Q1

Mean Difference (Final Values)-1.795% CI-9.0 - 5.6p0.643Mixed Models Analysis

Mean Difference (Final Values)-7.395% CI-14.7 - 0.1p0.052Mixed Models Analysis

Mean Difference (Final Values)-3.795% CI-14.0 - 6.6p0.481Mixed Models Analysis

Mean Difference (Final Values)-6.295% CI-15.6 - 3.2p0.195Mixed Models Analysis

Mean Difference (Final Values)-1.195% CI-12.9 - 10.7p0.857Mixed Models Analysis

Mean Difference (Final Values)-4.695% CI-15.9 - 6.7p0.422Mixed Models Analysis

Mean Difference (Final Values)-3.695% CI-15.7 - 8.6p0.562Mixed Models Analysis

Mean Difference (Final Values)8.895% CI-2.6 - 20.2p0.129Mixed Models Analysis

Mean Difference (Final Values)7.995% CI-4.0 - 19.9p0.194Mixed Models Analysis

Mean Difference (Final Values)1.395% CI-10.5 - 13.1p0.832Mixed Models Analysis

Mean Difference (Final Values)6.195% CI-6.8 - 19.1p0.351Mixed Models Analysis

Mean Difference (Final Values)-0.495% CI-13.3 - 12.5p0.949Mixed Models Analysis

Mean Difference (Final Values)8.395% CI-6.0 - 22.6p0.253Mixed Models Analysis

Mean Difference (Final Values)-2.495% CI-16.2 - 11.4p0.735Mixed Models Analysis

Mean Difference (Final Values)16.295% CI0.3 - 32.0p0.046Mixed Models Analysis

Secondary/registry result

Change From Baseline in Alzheimer's Carer Quality of Life Instrument (ACQLI) Total Score

Time frame:Baseline (Week 0), Week 12, 36 and 48

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on a scale	Standard error
PlaceboWeek 12n=387 Participants	0.5	0.23
Week 36n=341 Participants	1.0	0.28
Week 48n=315 Participants	1.2	0.30
2mg Rosiglitazone Extended ReleaseWeek 12n=405 Participants	-0.2	0.23
Week 36n=363 Participants	0.6	0.27
Week 48n=350 Participants	0.3	0.28
8mg Rosiglitazone Extended ReleaseWeek 12n=377 Participants	-0.0	0.22
Week 36n=327 Participants	0.6	0.26
Week 48n=309 Participants	1.1	0.31

Mean Difference (Final Values)-0.795% CI-1.2 - -0.1p0.027Mixed Models Analysis

Mean Difference (Final Values)-0.595% CI-1.1 - 0.1p0.091Mixed Models Analysis

Mean Difference (Final Values)-0.495% CI-1.1 - 0.3p0.268Mixed Models Analysis

Mean Difference (Final Values)-0.495% CI-1.1 - 0.4p0.318Mixed Models Analysis

Mean Difference (Final Values)-0.995% CI-1.6 - -0.1p0.030Mixed Models Analysis

Mean Difference (Final Values)-0.195% CI-0.9 - 0.7p0.797Mixed Models Analysis

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:Up to Week 54

event count, event

Secondary/registry result

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:Up to Week 54

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
PlaceboAny TEAEsn=496 Participants	304	-
Any SAEsn=496 Participants	62	-
2mg Rosiglitazone Extended ReleaseAny TEAEsn=494 Participants	273	-
Any SAEsn=494 Participants	45	-
8mg Rosiglitazone Extended ReleaseAny TEAEsn=489 Participants	327	-
Any SAEsn=489 Participants	50	-

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint

Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP)

Time frame:Baseline (Week 0), Week 4, 8, 12, 16, 24, 36, 48 and 56

change from baseline, improvement

Secondary/registry result

Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP)

Time frame:Baseline (Week 0), Week 4, 8, 12, 16, 24, 36, 48 and 56

change from baseline, improvement

Posted result

Group	Value (mean), Millimeter of mercury (mmHg)	Standard deviation
PlaceboSystolic BP Week 4n=457 Participants	-0.7	15.21
Systolic BP Week 8n=436 Participants	-0.3	15.49
Systolic BP Week 12n=431 Participants	-0.5	16.48
Systolic BP Week 16n=425 Participants	-0.8	15.80
Systolic BP Week 24n=413 Participants	-1.2	15.95
Systolic BP Week 36n=384 Participants	-1.6	16.65
Systolic BP Week 48n=363 Participants	-1.0	17.08
Systolic BP Week 54n=345 Participants	0.0	17.24
Diastolic BP Week 4n=457 Participants	-0.4	9.54
Diastolic BP Week 8n=436 Participants	-0.0	9.55
Diastolic BP Week 12n=431 Participants	0.0	9.63
Diastolic BP Week 16n=425 Participants	-0.7	9.78
Diastolic BP Week 24n=413 Participants	-1.1	9.87
Diastolic BP Week 36n=384 Participants	-1.2	10.27
Diastolic BP Week 48n=363 Participants	-0.8	10.85
Diastolic BP Week 54n=345 Participants	-0.9	10.35
2mg Rosiglitazone Extended ReleaseSystolic BP Week 4n=469 Participants	-1.0	13.21
Systolic BP Week 8n=460 Participants	-0.7	14.55
Systolic BP Week 12n=454 Participants	-2.5	14.49
Systolic BP Week 16n=442 Participants	-1.7	14.80
Systolic BP Week 24n=431 Participants	-1.0	15.22
Systolic BP Week 36n=406 Participants	-0.3	15.79
Systolic BP Week 48n=397 Participants	-0.6	15.05
Systolic BP Week 54n=385 Participants	-1.1	14.95
Diastolic BP Week 4n=469 Participants	-0.7	9.21
Diastolic BP Week 8n=460 Participants	-0.9	9.20
Diastolic BP Week 12n=454 Participants	-1.3	9.25
Diastolic BP Week 16n=442 Participants	-1.3	9.16
Diastolic BP Week 24n=431 Participants	-1.2	9.55
Diastolic BP Week 36n=406 Participants	-0.6	9.94
Diastolic BP Week 48n=397 Participants	-0.5	10.02
Diastolic BP Week 54n=385 Participants	-0.4	9.62
8mg Rosiglitazone Extended ReleaseSystolic BP Week 4n=457 Participants	-2.3	13.43
Systolic BP Week 8n=434 Participants	-2.9	14.49
Systolic BP Week 12n=415 Participants	-4.2	15.25
Systolic BP Week 16n=411 Participants	-3.7	15.75
Systolic BP Week 24n=392 Participants	-3.5	14.74
Systolic BP Week 36n=367 Participants	-2.7	15.97
Systolic BP Week 48n=345 Participants	-2.5	16.55
Systolic BP Week 54n=321 Participants	-2.3	15.56
Diastolic BP Week 4n=457 Participants	-1.2	8.51
Diastolic BP Week 8n=434 Participants	-2.1	9.21
Diastolic BP Week 12n=415 Participants	-2.5	9.49
Diastolic BP Week 16n=411 Participants	-3.0	9.62
Diastolic BP Week 24n=392 Participants	-2.6	9.48
Diastolic BP Week 36n=367 Participants	-3.3	10.68
Diastolic BP Week 48n=345 Participants	-1.9	11.07
Diastolic BP Week 54n=321 Participants	-1.8	10.04

Other (unclassified)

14 endpoints

Secondary/protocol endpoint/low confidence

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 48

Time frame:Baseline (Week 0) and Week 48

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Mean Change From Baseline in Heart Rate

Time frame:Baseline (Week 0), Week 4, 8, 12, 16, 24, 36, 48 and 56

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Mean Change From Baseline in Weight

Time frame:Baseline (Week 0), Week 4, 8, 12, 16, 24, 36, 48 and 56

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Hemoglobin Values

Time frame:Baseline (Week 0), Week 4, 16, 36 and 48

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Hematocrit Values

Time frame:Baseline (Week 0), Week 4, 8, 12, 16, 36 and 48

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in HbA1c at Week 12, Week 24 and Week 36

Time frame:Baseline (Week 0) and Week 12, 24 and 36

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Number of Participants With Laboratory Potential Clinical Concern (PCC) Values

Time frame:Baseline (Week 0), Week 4, 8, 12, 16, 24, 36, 48 and 56

event count, event

Secondary/registry result/low confidence

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 48

Time frame:Baseline (Week 0) and Week 48

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percentage of total hemoglobin	Standard error
Placebon=321 Participants	0.14	0.020
2mg Rosiglitazone Extended Releasen=352 Participants	0.21	0.020
8mg Rosiglitazone Extended Releasen=313 Participants	0.18	0.020

Mean Difference (Final Values)0.0795% CI0.02 - 0.12p0.006ANCOVA

Mean Difference (Final Values)0.0495% CI-0.01 - 0.09p0.140ANCOVA

Secondary/registry result/low confidence

Mean Change From Baseline in Heart Rate

Time frame:Baseline (Week 0), Week 4, 8, 12, 16, 24, 36, 48 and 56

change from baseline, improvement

Posted result

Group	Value (mean), beats per min (bpm)	Standard deviation
PlaceboWeek 4n=457 Participants	0.8	8.42
Week 8n=435 Participants	1.5	8.98
Week 12n=430 Participants	1.6	9.06
Week 16n=425 Participants	1.0	9.23
Week 24n=413 Participants	0.9	9.41
Week 36n=382 Participants	0.9	9.30
Week 48n=361 Participants	1.2	9.10
Week 54n=344 Participants	0.5	10.10
2mg Rosiglitazone Extended ReleaseWeek 4n=468 Participants	1.1	7.95
Week 8n=459 Participants	1.3	9.19
Week 12n=453 Participants	1.8	9.04
Week 16n=441 Participants	1.3	9.18
Week 24n=431 Participants	1.3	8.70
Week 36n=406 Participants	1.8	9.42
Week 48n=397 Participants	1.4	8.92
Week 54n=384 Participants	1.4	9.55
8mg Rosiglitazone Extended ReleaseWeek 4n=457 Participants	0.6	8.36
Week 8n=434 Participants	1.0	8.91
Week 12n=414 Participants	0.7	9.68
Week 16n=411 Participants	0.8	9.52
Week 24n=392 Participants	0.8	10.19
Week 36n=367 Participants	1.1	9.58
Week 48n=344 Participants	0.7	9.43
Week 54n=321 Participants	0.0	11.05

Secondary/registry result/low confidence

Mean Change From Baseline in Weight

Time frame:Baseline (Week 0), Week 4, 8, 12, 16, 24, 36, 48 and 56

change from baseline, improvement

Posted result

Group	Value (mean), kilogram (kg)	Standard deviation
PlaceboWeek 4n=456 Participants	0.1	2.04
Week 8n=436 Participants	0.2	2.35
Week 12n=430 Participants	0.2	2.50
Week 16n=425 Participants	0.1	2.88
Week 24n=413 Participants	0.1	2.88
Week 36n=384 Participants	0.0	3.37
Week 48n=363 Participants	0.4	3.54
Week 54n=346 Participants	0.3	3.74
2mg Rosiglitazone Extended ReleaseWeek 4n=471 Participants	0.2	1.66
Week 8n=460 Participants	0.3	1.95
Week 12n=453 Participants	0.3	2.09
Week 16n=441 Participants	0.3	2.44
Week 24n=430 Participants	0.6	2.77
Week 36n=405 Participants	0.7	3.00
Week 48n=396 Participants	0.8	3.47
Week 54n=384 Participants	0.7	3.69
8mg Rosiglitazone Extended ReleaseWeek 4n=458 Participants	0.3	1.88
Week 8n=435 Participants	0.7	2.37
Week 12n=414 Participants	0.9	2.33
Week 16n=412 Participants	1.0	2.56
Week 24n=391 Participants	0.9	3.26
Week 36n=367 Participants	1.3	3.92
Week 48n=346 Participants	1.3	4.13
Week 54n=322 Participants	0.8	4.53

Secondary/registry result/low confidence

Change From Baseline in Hemoglobin Values

Time frame:Baseline (Week 0), Week 4, 16, 36 and 48

change from baseline, improvement

Posted result

Group	Value (mean), grams per litre (g/L)	Standard deviation
PlaceboWeek 4n=453 Participants	-0.4	6.45
Week 16n=423 Participants	-0.6	7.01
Week 36n=382 Participants	-2.0	7.25
Week 48n=346 Participants	-1.9	7.86
2mg Rosiglitazone Extended ReleaseWeek 4n=457 Participants	-2.5	6.92
Week 16n=444 Participants	-6.2	7.76
Week 36n=398 Participants	-6.4	8.04
Week 48n=377 Participants	-6.5	8.45
8mg Rosiglitazone Extended ReleaseWeek 4n=457 Participants	-3.7	6.19
Week 16n=407 Participants	-11.9	8.65
Week 36n=363 Participants	-12.5	9.38
Week 48n=334 Participants	-12.2	10.62

Secondary/registry result/low confidence

Change From Baseline in Hematocrit Values

Time frame:Baseline (Week 0), Week 4, 8, 12, 16, 36 and 48

change from baseline, improvement

Posted result

Group	Value (mean), litre	Standard deviation
PlaceboWeek 4n=453 Participants	-0.0007	0.02133
Week 16n=423 Participants	-0.0003	0.02318
Week 36n=382 Participants	-0.0037	0.02246
Week 48n=346 Participants	-0.0029	0.02447
2mg Rosiglitazone Extended ReleaseWeek 4n=457 Participants	-0.0068	0.02189
Week 16n=444 Participants	-0.0174	0.02460
Week 36n=398 Participants	-0.0167	0.02471
Week 48n=377 Participants	-0.0177	0.02658
8mg Rosiglitazone Extended ReleaseWeek 4n=457 Participants	-0.0115	0.01994
Week 16n=407 Participants	-0.0339	0.02697
Week 36n=363 Participants	-0.0352	0.02834
Week 48n=334 Participants	-0.0346	0.03177

Secondary/registry result/low confidence

Change From Baseline in HbA1c at Week 12, Week 24 and Week 36

Time frame:Baseline (Week 0) and Week 12, 24 and 36

change from baseline, improvement

Posted result

Group	Value (mean), Percent of total hemoglobin	Standard deviation
PlaceboWeek 12n=82 Participants	0.01	0.336
Week 24n=145 Participants	0.07	0.401
Week 36n=140 Participants	0.20	0.400
2mg Rosiglitazone Extended ReleaseWeek 12n=78 Participants	0.14	0.634
Week 24n=150 Participants	0.12	0.422
Week 36n=145 Participants	0.19	0.430
8mg Rosiglitazone Extended ReleaseWeek 12n=81 Participants	0.16	0.407
Week 24n=124 Participants	0.06	0.551
Week 36n=127 Participants	0.15	0.526

Secondary/registry result/low confidence

Number of Participants With Laboratory Potential Clinical Concern (PCC) Values

Time frame:Baseline (Week 0), Week 4, 8, 12, 16, 24, 36, 48 and 56

event count, event

Posted result

Group	Value (number), participants	Reported bounds
PlaceboEosinophils highn=471 Participants	0	-
Hematocrit lown=471 Participants	2	-
Hemoglobin highn=471 Participants	2	-
Hemoglobin lown=471 Participants	8	-
Lymphocytes highn=471 Participants	0	-
Lymphocytes lown=471 Participants	8	-
Mean CH highn=471 Participants	0	-
Mean CH lown=471 Participants	2	-
Mean CV highn=471 Participants	0	-
Mean CV lown=471 Participants	2	-
Monocytes lown=471 Participants	81	-
Platelet count highn=471 Participants	4	-
Platelet count lown=471 Participants	1	-
RDW highn=471 Participants	18	-
RBC highn=471 Participants	0	-
RBC lown=471 Participants	0	-
SN highn=471 Participants	8	-
SN lown=471 Participants	2	-
TN highn=471 Participants	4	-
TN lown=471 Participants	2	-
WBC highn=471 Participants	4	-
WBC lown=471 Participants	1	-
2mg Rosiglitazone Extended ReleaseEosinophils highn=486 Participants	3	-
Hematocrit lown=486 Participants	2	-
Hemoglobin highn=486 Participants	0	-
Hemoglobin lown=486 Participants	11	-
Lymphocytes highn=486 Participants	1	-
Lymphocytes lown=486 Participants	10	-
Mean CH highn=486 Participants	0	-
Mean CH lown=486 Participants	2	-
Mean CV highn=486 Participants	0	-
Mean CV lown=486 Participants	1	-
Monocytes lown=486 Participants	55	-
Platelet count highn=486 Participants	2	-
Platelet count lown=486 Participants	2	-
RDW highn=486 Participants	31	-
RBC highn=486 Participants	1	-
RBC lown=486 Participants	1	-
SN highn=486 Participants	2	-
SN lown=486 Participants	6	-
TN highn=486 Participants	1	-
TN lown=486 Participants	6	-
WBC highn=486 Participants	1	-
WBC lown=486 Participants	5	-
8mg Rosiglitazone Extended ReleaseEosinophils highn=477 Participants	0	-
Hematocrit lown=477 Participants	5	-
Hemoglobin highn=477 Participants	0	-
Hemoglobin lown=477 Participants	31	-
Lymphocytes highn=477 Participants	2	-
Lymphocytes lown=477 Participants	13	-
Mean CH highn=477 Participants	1	-
Mean CH lown=477 Participants	0	-
Mean CV highn=477 Participants	1	-
Mean CV lown=477 Participants	0	-
Monocytes lown=477 Participants	65	-
Platelet count highn=475 Participants	7	-
Platelet count lown=475 Participants	4	-
RDW highn=475 Participants	86	-
RBC highn=477 Participants	0	-
RBC lown=477 Participants	8	-
SN highn=477 Participants	4	-
SN lown=477 Participants	13	-
TN highn=477 Participants	2	-
TN lown=477 Participants	13	-
WBC highn=477 Participants	3	-
WBC lown=477 Participants	12	-

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Harrington C, Sawchak S, Chiang C, Davies J, Donovan C, Saunders AM, Irizarry M, Jeter B, Zvartau-Hind M, van Dyck CH, Gold M. Rosiglitazone does not improve cognition or global function when used as adjunctive therapy to AChE inhibitors in mild-to-moderate Alzheimer's disease: two phase 3 studies. Curr Alzheimer Res. 2011 Aug;8(5):592-606. doi: 10.2174/156720511796391935.
PMID21592048via BACKGROUND

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.