TerminatedPhase 3Results posted

Study Of Rosiglitazone XR In Subjects With Mild-to-Moderate Alzheimers

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.

Lead sponsor

GlaxoSmithKline

Asset

Rosiglitazone

Listed sites

Recruiting sites

Enrollment

331

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Study partner/caregiver required

Primary endpoint

•Any Adverse Events (AEs) and Severity of AEs

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 IDAVA102677

NCT IDNCT00550420

Timeline

Milestones

Study start2007-10-01actual

Study first posted2007-10-29estimated

Primary completion2009-02-12actual

Study completion2009-02-12actual

Last update posted2017-11-08actual

Results first posted2017-11-08actual

Assets

Drug assets

Rosiglitazone

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age51 Years

Maximum age91 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female subject who has successfully completed Visit 8 of AVA105640 without safety/tolerability issues, where in the opinion of the subject /carer and of the investigator, it would be beneficial to receive RSG XR

•Female subjects able to bear children must agree to use an adequate method of contraception for the duration of the study for details of highly effective methods to avoid pregnancy). Female subjects who are pre-menopausal or who have been post-menopausal for <1 year must undertake pregnancy testing (urine test) £7 days before Visit 1, which must be negative

•Subject is willing to participate in the extension study and has provided full written informed consent prior to the performance of any protocol-specified procedure; or if unable to provide informed consent due to cognitive status, full written informed consent on behalf of the subject has been provided by a legally acceptable representative (where this is in accordance with local laws, regulations and ethics committee policy)

•Subject lives with (or has substantial periods of contact with) a regular caregiver who is willing to attend all visits, oversee the subject's compliance with protocol-specified procedures and study medication, and report on subject's status

•Subject has the ability to comply with procedures for cognitive and other testing

•Caregiver has provided full written informed consent on his or her own behalf prior to the performance of any protocol-specified procedure

•Subjects considered for enrollment must have a QTc (either QTc B (Bazett's correction) or QTc F (Fridericia's correction)) <450msec at Visit 1, with the exception of subjects with bundle branch block (for whom either QTc B or QTc F must be <480msec)

•In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category

•Post-menopause [Becker, 2001]: Menopause is the age associated with complete cessation of menstrual cycles, menses, and implies the loss of reproductive potential by ovarian failure. This typically occurs around age 50, although it may occur earlier. A practical definition accepts menopause after one year without menses with an appropriate clinical profile, e.g., age appropriate, >45 years, in the absence of hormone replacement therapy. In questionable cases, a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory (these levels are suggested guidelines and may need to be adjusted for specific laboratories/assays

•Females, who are on hormone replacement therapy (HRT), and whose menopausal status is in doubt, will be required to use a highly effective method to avoid pregnancy, as outlined in the protocol, if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw as detailed in the preceding paragraph; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a highly effective method to avoid pregnancy

•A non-cohabiting caregiver must spend sufficient time with the subject so that, in the opinion of the Investigator, the caregiver can reliably assess cognitive function, activities and behaviour, and report on the subject's compliance and health. As caregiver time spent with a potential subject is anticipated to be highly variable across countries and cultures, GSK will consider a variety of different measures by which this stipulation may be met, and GSK should be consulted if adequacy of a caregiver situation is in doubt. However, as guidance, the ability for a caregiver to meet his/her expected responsibilities for this study would normally be possible when the caregiver spends no less than 10 hours per week with the subject, divided over multiple days

•For the purposes of these criteria, QTc B is defined as (QT interval [msec]) / (square root of RR interval [seconds]); and QTc F is defined as (QT interval [msec]) / (cube root of RR interval [seconds])

Exclusion criteria

•Subject had a serious adverse experience or clinically significant laboratory abnormality during AVA105640, which in the opinion of the investigator could have been attributable to study medication, and which is ongoing at Visit 1

•The subject is felt by the investigator to be unsuitable (on the basis of health, compliance, caregiver availability, or for any other reason) for inclusion in the study

•The subject experienced a significant cardiovascular event during AVA105640 (e.g. intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome [non Q-wave myocardial infarction, Q-wave myocardial infarction, unstable angina] or significant arrhythmia), unless a thorough cardiovascular evaluation has been performed which confirms that the subject does not have congestive heart failure, and is clinically stable

•Clinical/investigational evidence of congestive heart failure defined by the New York Heart Association (NYHA) criteria (Class I to IV cardiac status) at the time of Visit 1

•Clinically significant peripheral oedema at the time of Visit 1

•Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase values >2.5 times the upper limit of normal (ULN), total bilirubin values >1.5 times the ULN, or history of severe hepatobiliary disease (e.g. hepatitis B or C, or cirrhosis, Child-Pugh Class B/C)

•Subject is an immediate family member or employee of the participating Investigator, of any of the participating site staff, or of GSK

•In France, a subject is neither affiliated with nor a beneficiary of a social security category

•In France, a subject has participated in any study using an investigational drug during the previous 30 days (except for participation in AVA105640)

Endpoints (36)

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

Safety / tolerability / PK

Global cognition

Function / daily living

Behavior / neuropsychiatric

Caregiver / quality of life

Other (unclassified)

Global cognition

4 endpoints

Secondary/protocol endpoint

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

Time frame:Baseline (Visit 1, W0), W24 and W52

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Mini Mental State Examination (MMSE) Total Score as a Function of APOE 4 Status at W24 and W52

Time frame:Baseline (Visit 1, W0), W 24 and W52

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

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

Time frame:Baseline (Visit 1, W0), W24 and W52

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), Score on scale	Standard deviation
RSG XR 8 mgAll subject population, W24n=243 Participants	1.9	5.23
All subject population, W52n=58 Participants	2.5	5.69
APOE4, Neg, W24n=115 Participants	2.1	5.29
APOE4, Neg, W52n=32 Participants	3.0	5.40
APOEe4, Pos, W24n=128 Participants	1.8	5.19
APOEe4, Pos, W52n=26 Participants	1.8	6.07

Secondary/registry result

Change From Baseline in Mini Mental State Examination (MMSE) Total Score as a Function of APOE 4 Status at W24 and W52

Time frame:Baseline (Visit 1, W0), W 24 and W52

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), Score on scale	Standard deviation
RSG XR 8 mgAll subject population, W24n=203 Participants	-0.7	2.65
All subject population, W52n=19 Participants	-1.6	2.85
APOEe4, Neg, W24n=91 Participants	-0.7	2.70
APOEe4, Neg, W52n=11 Participants	-1.2	3.37
APOEe4, Pos, W24n=331 Participants	-0.7	2.63
APOEe4, Pos, W52n=8 Participants	-2.1	2.03

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score as a Function of APOEe 4 Status

Time frame:Baseline (Visit 1, W0), W24 and W52

change from baseline, improvement

Secondary/registry result

Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score as a Function of APOEe 4 Status

Time frame:Baseline (Visit 1, W0), W24 and W52

change from baseline, improvement

Posted result

Group	Value (mean), Score on scale	Standard deviation
RSG XR 8 mgAll subject population, W24n=203 Participants	-3.2	10.23
All subject population, W52n=19 Participants	-5.2	18.21
APOEe4, Neg, W24n=91 Participants	-4.5	11.57
APOEe4, Neg, W52n=11 Participants	-6.2	22.66
APOEe4, Pos, W24n=112 Participants	-2.2	8.91
APOEe4, Pos, W52n=8 Participants	-3.8	10.73

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score as a Function of APOE 4 Status at W24 and W52

Time frame:Baseline (Visit 1, W0), W24 and W52

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score as a Function of APOE 4 Status at W24 and W52

Time frame:Baseline (Visit 1, W0), W24 and W52

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Score on scale	Standard deviation
RSG XR 8 mgAll subject population, W24n=203 Participants	1.1	7.07
All subject population, W52n=19 Participants	2.1	9.55
APOEe4, Neg, W24n=91 Participants	1.9	8.24
APOEe4, Neg, W52n=11 Participants	1.5	9.41
APOEe4, Pos, W24n=112 Participants	0.4	5.91
APOEe4, Pos, W52n=8 Participants	2.8	10.35

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

Mean Clinician Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Score as a Function of APOE 4 Status

Time frame:Baseline (Visit 1, W0), W 24 and W 52

categorical status, descriptive

Secondary/registry result

Mean Clinician Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Score as a Function of APOE 4 Status

Time frame:Baseline (Visit 1, W0), W 24 and W 52

categorical status, descriptive

Posted result

Group	Value (mean), Score on scale	Standard deviation
RSG XR 8 mgAll subject population, W24n=241 Participants	4.3	1.05
All subject population, W52n=60 Participants	4.5	1.10
APOEe4, Neg, W24n=113 Participants	4.3	1.04
APOEe4, Neg, W52n=33 Participants	4.7	1.16
APOEe4, Pos, W24n=128 Participants	4.3	1.05
APOEe4, Pos, W52n=27 Participants	4.3	0.99

Safety / tolerability / PK

24 endpoints

Primary/protocol endpoint

Number of Participants With Any Adverse Events (AEs) and Severity of AEs

Time frame:Up to Week 82

event count, event

Primary/registry result

Number of Participants With Any Adverse Events (AEs) and Severity of AEs

Time frame:Up to Week 82

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
RSG XR 8mgAny AEsn=331 Participants	125	-
Total Drug-Related AESIn=331 Participants	46	-
Mild AESIn=331 Participants	31	-
Moderate AESIn=331 Participants	13	-
Severe AESIn=331 Participants	2	-

Secondary/protocol endpoint

Number of Participants With Serious AEs and Deaths

Time frame:Up to Week 82

event count, event

Secondary/protocol endpoint

Percentage of Participants With AEs of Edema

Time frame:Up to 82 Weeks

threshold achievement, event

Secondary/protocol endpoint

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Time frame:Baseline (Visit 1, W0), W4, W8, W12, W16, W24, W36, W52, W64 and Follow-up (W82)

change from baseline, event

Secondary/protocol endpoint

Change From Baseline in Heart Rate (HR)

Time frame:Baseline (Visit 1, W0), W4, W8, W12, W16, W24, W36, W52, W64 and Follow-up (W82)

change from baseline, event

Secondary/protocol endpoint

Number of Participants With Abnormal SBP and DBP at Any Time During Treatment Period

Time frame:Up to 82 weeks

change from baseline, event

Secondary/protocol endpoint

Number of Participants With Abnormal HR at Any Time During Treatment Period

Time frame:Up to 82 weeks

change from baseline, event

Secondary/protocol endpoint

Change From Baseline in Body Weight (BW)

Time frame:Baseline (Visit 1, W0), W4, W8, W12, W16, W24, W36, W52, W64 and Follow-up (W82)

change from baseline, event

Secondary/protocol endpoint

Number of Participants With Abnormal BW at Any Time During Treatment Period

Time frame:Baseline (Visit 1, W0) to W 52

change from baseline, event

Secondary/protocol endpoint

Number of Participants With Hematological Parameters of Potential Clinical Concern

Time frame:Up to 82 weeks

event count, event

Secondary/protocol endpoint

Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern

Time frame:Up to 82 weeks

event count, event

Secondary/protocol endpoint

Change From Baseline in Glycosylated Haemoglobin (HbA1c)

Time frame:Baseline (Vsit 1 W0), W12, W24, W36, W52, W76 and Follow-up (W82)

change from baseline, event

Secondary/registry result

Number of Participants With Serious AEs and Deaths

Time frame:Up to Week 82

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
RSG XR 8 mgAny SAEn=331 Participants	8	-
Deathn=331 Participants	3	-

Secondary/registry result

Percentage of Participants With AEs of Edema

Time frame:Up to 82 Weeks

threshold achievement, event

Posted result

Group	Value (number), Percentage of participants	Reported bounds
RSG XR 8 mgn=331 Participants	13	-

Secondary/registry result

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Time frame:Baseline (Visit 1, W0), W4, W8, W12, W16, W24, W36, W52, W64 and Follow-up (W82)

change from baseline, event

Posted result

Group	Value (mean), millimeter of mercury (mmHg)	Standard deviation
RSG XR 8 mgSBP, W4n=318 Participants	-0.2	11.61
SBP, W8n=294 Participants	-1.1	11.83
SBP, W12n=281 Participants	-0.7	13.80
SBP, W16n=271 Participants	-1.3	13.66
SBP, W24n=231 Participants	-1.2	13.30
SBP, W36n=134 Participants	-3.0	15.37
SBP, W52n=37 Participants	0.3	12.85
SBP, Year 2 W12n=10 Participants	-0.1	16.93
SBP, Follow-upn=280 Participants	-0.5	12.32
DBP, W4n=318 Participants	-0.8	7.59
DBP, W8n=294 Participants	-2.1	8.52
DBP, W12n=281 Participants	-2.0	8.74
DBP, W16n=271 Participants	-2.2	9.00
DBP, W24n=231 Participants	-2.1	8.53
DBP, W36n=134 Participants	-3.0	9.11
DBP, W52n=37 Participants	-1.4	8.26
DBP, Year 2 W12n=10 Participants	2.8	9.86
DBP, Follow-upn=280 Participants	-0.9	9.04

Secondary/registry result

Change From Baseline in Heart Rate (HR)

Time frame:Baseline (Visit 1, W0), W4, W8, W12, W16, W24, W36, W52, W64 and Follow-up (W82)

change from baseline, event

Posted result

Group	Value (mean), BPM	Standard deviation
RSG XR 8mgHR, W4n=318 Participants	1.1	7.19
HR, W8n=294 Participants	1.8	7.44
HR, W12n=281 Participants	2.2	8.70
HR, W16n=271 Participants	1.2	7.89
HR, W24n=231 Participants	1.0	7.87
HR, W36n=134 Participants	1.7	7.60
HR, W52n=37 Participants	-0.8	8.87
HR, Year 2 W12n=10 Participants	2.9	10.64
HR, Follow-upn=280 Participants	1.6	8.17

Secondary/registry result

Number of Participants With Abnormal SBP and DBP at Any Time During Treatment Period

Time frame:Up to 82 weeks

change from baseline, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
RSG XR 8 mgSBP, >140 or <90,n=331 Participants	84	-
SBP, Increase from Baseline >=40,n=331 Participants	8	-
SBP, Decrease from Baseline >=30,n=331 Participants	22	-
DBP, >90 or <50,n=331 Participants	23	-
DBP, Increase from Baseline >=30,n=331 Participants	2	-
DBP, Decrease from Baseline >=20,n=331 Participants	31	-

Secondary/registry result

Number of Participants With Abnormal HR at Any Time During Treatment Period

Time frame:Up to 82 weeks

change from baseline, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
RSG XR 8 mgHR, >100 or <50n=319 Participants	3	-
HR, Increase from baseline >=30n=319 Participants	2	-

Secondary/registry result

Change From Baseline in Body Weight (BW)

Time frame:Baseline (Visit 1, W0), W4, W8, W12, W16, W24, W36, W52, W64 and Follow-up (W82)

change from baseline, event

Posted result

Group	Value (mean), Kilograms (kg)	Standard deviation
RSG XR 8 mgBW, W4n=318 Participants	0.2	1.57
BW, W8n=293 Participants	0.4	2.42
BW, W12n=281 Participants	0.5	2.06
BW, W16n=271 Participants	0.5	2.59
BW, W24n=231 Participants	0.6	2.80
BW, W36n=134 Participants	0.5	3.60
BW, W52n=37 Participants	-0.0	3.75
BW, Year 2 W12n=10 Participants	0.5	3.92
BW, Follow-upn=280 Participants	0.5	3.04

Secondary/registry result

Number of Participants With Abnormal BW at Any Time During Treatment Period

Time frame:Baseline (Visit 1, W0) to W 52

change from baseline, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
RSG XR 8 mgIncrease from Baseline >=7%n=318 Participants	30	-
Decrease from Baseline >=7%n=318 Participants	16	-

Secondary/registry result

Number of Participants With Hematological Parameters of Potential Clinical Concern

Time frame:Up to 82 weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
RSG XR 8 mgEosinophils, ATOT, Highn=308 Participants	1	-
Hematocrit, ATOT, Lown=308 Participants	2	-
Hematocrit, Follow-up, Lown=139 Participants	1	-
Hemoglobin, ATOT, Highn=308 Participants	1	-
Hemoglobin, ATOT, Lown=308 Participants	20	-
Hemoglobin, Follow-Up, Lown=139 Participants	8	-
Lymphocytes, ATOT, Lown=308 Participants	5	-
Lymphocytes, Follow-Up, Lown=137 Participants	3	-
MCH, ATOT, Highn=308 Participants	1	-
MCH, Follow-Up, Highn=139 Participants	1	-
MCV, ATOT, Highn=308 Participants	1	-
MCV, Follow-Up, Highn=139 Participants	1	-
Monocytes, ATOT, Lown=308 Participants	17	-
Monocytes, ATOT, Highn=137 Participants	5	-
Platelet count, ATOT, Highn=308 Participants	1	-
Platelet count, ATOT, Lown=308 Participants	2	-
Red Cell Distribution Width, ATOT, Highn=308 Participants	30	-
Red Cell Distribution Width,Follow-up, Highn=139 Participants	8	-
Red Blood Cell count, ATOT, Lown=308 Participants	4	-
Red Blood Cell count, Follow-up, Lown=139 Participants	4	-
Segmented Neutrophils, ATOT, Highn=308 Participants	1	-
Segmented Neutrophils, ATOT, Lown=308 Participants	14	-
Segmented Neutrophils, Follow-up, Lown=137 Participants	2	-
Total Neutrophils, ATOT, Highn=308 Participants	1	-
Total Neutrophils, ATOT, Lown=308 Participants	14	-
Total Neutrophils, Follow-Up, Lown=137 Participants	2	-
WBC, ATOT, Lown=308 Participants	9	-

Secondary/registry result

Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern

Time frame:Up to 82 weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
RSG XR 8 mgALT, ATOT, Highn=309 Participants	1	-
ALT, Follow-up, Highn=142 Participants	1	-
Aldolase, ATOT, Highn=56 Participants	3	-
Aldolase, ATOT, Lown=56 Participants	7	-
Aldolase, Follow-up, Lown=24 Participants	3	-
AST, ATOT, Highn=309 Participants	2	-
AST, Follow-up, Highn=142 Participants	1	-
BUN/Creat ratio, ATOT, Highn=309 Participants	18	-
BUN/Creat ratio, Follow-up, Highn=142 Participants	1	-
Chol, ATOT, Highn=309 Participants	52	-
Chol, Follow-up, Highn=142 Participants	13	-
Creatine Kinase, ATOT, Highn=309 Participants	32	-
Creatine Kinase, Follow-up, Highn=142 Participants	7	-
Creatinin, ATOT, Highn=309 Participants	4	-
Creatinin, Follow-up, Highn=142 Participants	5	-
Direct Bilirubin, ATOT, Highn=309 Participants	1	-
GGT, ATOT, Highn=309 Participants	308	-
GGT, Follow-up, Highn=142 Participants	142	-
Glucose, ATOT, Highn=309 Participants	19	-
Glucose, ATOT, Lown=309 Participants	5	-
Glucose, Follow-up, Highn=142 Participants	8	-
HDL, ATOT, Lown=309 Participants	1	-
LDL, ATOT, Highn=307 Participants	135	-
LDL, Follow-up, Highn=142 Participants	45	-
Potassium, ATOT, Highn=309 Participants	4	-
Potassium, ATOT, Lown=309 Participants	1	-
Troponin I, ATOT, Highn=47 Participants	2	-
Urea, ATOT, Highn=309 Participants	19	-
Urea, Follow-up, Highn=142 Participants	7	-

Secondary/registry result

Change From Baseline in Glycosylated Haemoglobin (HbA1c)

Time frame:Baseline (Vsit 1 W0), W12, W24, W36, W52, W76 and Follow-up (W82)

change from baseline, event

Posted result

Group	Value (mean), Percent HbA1c	Standard deviation
RSG XR 8 mgW12n=61 Participants	-0.02	0.573
W24n=65 Participants	0.08	0.512
W36n=59 Participants	0.03	0.417
W52n=29 Participants	0.09	0.377
W76n=8 Participants	0.08	0.369
Follow-upn=95 Participants	0.07	0.540

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Change From Baseline in Non-fasting Measures of Lipid Metabolism Including Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein and Triglycerides at Indicated Timepoints.

Time frame:Baseline (Visit 1, W0), W4, W16, W36, W52, W76, and W82

change from baseline, improvement

Secondary/registry result/low confidence

Change From Baseline in Non-fasting Measures of Lipid Metabolism Including Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein and Triglycerides at Indicated Timepoints.

Time frame:Baseline (Visit 1, W0), W4, W16, W36, W52, W76, and W82

change from baseline, improvement

Posted result

Group	Value (mean), Millimoles per litre	Standard deviation
RSG XR 8 mgTC, W4n=288 Participants	0.106	0.7341
TC, W16n=254 Participants	0.200	0.9713
TC, W36n=142 Participants	0.140	1.0659
TC, W52n=35 Participants	0.333	1.2454
TC, Year 2 W24n=8 Participants	1.163	0.6604
TC, Follow-upn=134 Participants	0.069	0.9649
HDL, W4n=288 Participants	-0.035	0.2217
HDL, W16n=254 Participants	-0.030	0.2597
HDL, W36n=142 Participants	-0.069	0.2711
HDL, W52n=35 Participants	-0.020	0.3420
HDL, Year 2 W24n=8 Participants	-0.150	0.4104
HDL, Follow-upn=134 Participants	-0.057	0.2325
LDL, W4n=281 Participants	0.088	0.6689
LDL, W16n=248 Participants	0.211	0.9151
LDL, W36n=140 Participants	0.163	0.9484
LDL, W52n=34 Participants	0.385	1.0346
LDL, Year 2 W24n=8 Participants	1.051	0.5836
LDL, Follow-upn=132 Participants	0.133	0.8985
TG, W4n=288 Participants	0.084	0.6918
TG, W16n=254 Participants	0.027	0.8355
TG, W36n=142 Participants	0.050	0.8774
TG, W52n=35 Participants	-0.179	1.0565
TG, Year 2 W24n=8 Participants	0.573	0.8992
TG, Follow-upn=134 Participants	-0.062	0.7616

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

Gold M, Alderton C, Zvartau-Hind M, Egginton S, Saunders AM, Irizarry M, Craft S, Landreth G, Linnamagi U, Sawchak S. Rosiglitazone monotherapy in mild-to-moderate Alzheimer's disease: results from a randomized, double-blind, placebo-controlled phase III study. Dement Geriatr Cogn Disord. 2010;30(2):131-46. doi: 10.1159/000318845. Epub 2010 Aug 21.
PMID20733306via 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.