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TerminatedPhase 3Results posted

Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers

An Open-label Extension to Study AVA102670 and AVA102672, to Assess the Long-term Safety and Efficacy of Rosiglitazone (Extended Release Tablets) as Adjunctive Therapy on Cognition in Subjects With Mild to Moderate Alzheimer's Disease.

Lead sponsor

GlaxoSmithKline

Asset

Rosiglitazone

Listed sites

272

Recruiting sites

-

Enrollment

1,461

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 51-91

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 IDAVA102675
NCT IDNCT00490568

Timeline

Milestones

Study first posted2007-06-22estimated
Study start2007-08-08actual
Primary completion2009-06-01actual
Study completion2009-06-01actual
Last update posted2017-11-13actual
Results first posted2017-11-13actual

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

•Successful completion of AVA102670 or AVA102672 without safety or tolerability issues. Regular caregiver

Exclusion criteria

•Congestive Heart Failure (NYHA 1-4), clinically significant peripheral edema, other neurological conditions that might disqualify participation. SAE, clinically significant laboratory abnormality or significant cardiovascular event during prior study.

Endpoints (34)

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
18
Global cognition
6
Other (unclassified)
6
Function / daily living
2
Behavior / neuropsychiatric
2

Global cognition

6 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) ε4 Status.

Time frame:Baseline (Week 0) and Week 24, 52

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score as a Function of APOE ε4 Status.

Time frame:Baseline (Week 0) and Week 24, 52

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

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Mini Mental State Examination (MMSE) Total Score as a Function of APOE ε4 Status.

Time frame:Baseline (Week 0) and Week 24, 52

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) ε4 Status.

Time frame:Baseline (Week 0) and Week 24, 52

ADAS-Cog

change from baseline, improvement

Posted result

GroupValue (mean), Scores on scaleStandard deviation
RSG XRWeek 24 (Full population)n=973 Participants2.55.51
Week 52 (Full population)n=308 Participants5.16.82
Week 24 (APOE4 negatives)n=404 Participants2.35.28
Week 52 (APOE4 negatives)n=135 Participants4.86.44
Week 24 (APOE4 positives)n=569 Participants2.65.66
Week 52(APOE4 positives)n=173 Participants5.47.11
Week 24 (APOE4 E4 homozygotes)n=126 Participants2.75.77
Week 52 (APOE4 E4 homozygotes)n=39 Participants5.27.49
Week 24 (APOE4 E4 heterozygotes)n=443 Participants2.65.63
Week 52 (APOE4 E4 heterozygotes)n=134 Participants5.47.02
Secondary/registry result

Change From Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score as a Function of APOE ε4 Status.

Time frame:Baseline (Week 0) and Week 24, 52

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

change from baseline, improvement

Posted result

GroupValue (mean), Scores on scaleStandard deviation
RSG XRWeek 24 (Full population)n=988 Participants0.71.84
Week 52 (Full population)n=313 Participants1.62.26
Week 24 (APOE4 negatives)n=409 Participants0.61.76
Week 52 (APOE4 negatives)n=139 Participants1.32.19
Week 24 (APOE4 positives)n=579 Participants0.71.89
Week 52 (APOE4 positives)n=174 Participants1.92.30
Week 24 (APOE4 E4 homozygotes)n=127 Participants0.91.90
Week 52 (APOE4 E4 homozygotes)n=39 Participants1.92.32
Week 24 (APOE4 E4 heterozygotes)n=452 Participants0.71.89
Week 52 (APOE4 E4 heterozygotes)n=135 Participants1.92.30
Secondary/registry result

Change From Baseline in Mini Mental State Examination (MMSE) Total Score as a Function of APOE ε4 Status.

Time frame:Baseline (Week 0) and Week 24, 52

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

GroupValue (mean), Scores on scaleStandard deviation
RSG XRWeek 24 (Full population)n=833 Participants-1.22.84
Week 52 (Full population)n=184 Participants-2.33.39
Week 24 (APOE4 negatives)n=353 Participants-0.72.74
Week 52 (APOE4 negatives)n=77 Participants-1.53.56
Week 24 (APOE4 positives)n=480 Participants-1.52.87
Week 52 (APOE4 positives)n=107 Participants-2.83.17
Week 24 (APOE4 E4 homozygotes)n=104 Participants-1.53.07
Week 52 (APOE4 E4 homozygotes)n=23 Participants-2.53.16
Week 24 (APOE4 E4 heterozygotes)n=376 Participants-1.52.82
Week 52 (APOE4 E4 heterozygotes)n=84 Participants-2.93.18

Function / daily living

2 endpoints
Secondary/protocol endpoint

Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score as a Function of APOE ε4 Status.

Time frame:Baseline (Week 0) and Week 24, 52

change from baseline, improvement

Secondary/registry result

Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score as a Function of APOE ε4 Status.

Time frame:Baseline (Week 0) and Week 24, 52

change from baseline, improvement

Posted result

GroupValue (mean), Scores on scaleStandard deviation
RSG XRWeek 24 (Full population)n=837 Participants-5.612.36
Week 52 (Full population)n=183 Participants-10.815.07
Week 24 (APOE4 negatives)n=354 Participants-4.611.57
Week 52 (APOE4 negatives)n=77 Participants-10.914.90
Week 24 (APOE4 positives)n=483 Participants-6.212.88
Week 52 (APOE4 positives)n=106 Participants-10.715.26
Week 24 (APOE4 E4 homozygotes)n=106 Participants-5.612.16
Week 52 (APOE4 E4 homozygotes)n=24 Participants-12.611.84
Week 24 (APOE4 E4 heterozygotes)n=377 Participants-6.413.08
Week 52 (APOE4 E4 heterozygotes)n=82 Participants-10.116.14

Behavior / neuropsychiatric

2 endpoints
Secondary/protocol endpoint

Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score as a Function of APOE ε4 Status.

Time frame:Baseline (Week 0) and Week 24, 52

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score as a Function of APOE ε4 Status.

Time frame:Baseline (Week 0) and Week 24, 52

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

GroupValue (mean), Score on scaleStandard deviation
RSG XRWeek 24 (Full population)n=835 Participants1.47.87
Week 52 (Full population)n=183 Participants3.210.90
Week 24 (APOE4 negatives)n=353 Participants1.07.26
Week 52 (APOE4 negatives)n=77 Participants2.47.74
Week 24 (APOE4 positives)n=482 Participants1.78.29
Week 52 (APOE4 positives)n=106 Participants3.812.71
Week 24 (APOE4 E4 homozygotes)n=105 Participants1.87.75
Week 52 (APOE4 E4 homozygotes)n=24 Participants4.214.19
Week 24 (APOE4 E4 heterozygotes)n=377 Participants1.68.45
Week 52 (APOE4 E4 heterozygotes)n=82 Participants3.712.34

Safety / tolerability / PK

18 endpoints
Primary/protocol endpoint

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

Time frame:Up to 76 Weeks

event count, event

Primary/registry result

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

Time frame:Up to 76 Weeks

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
RSG XRAny AEn=1461 Participants724-
Mild AEn=1461 Participants345-
Moderate AEn=1461 Participants289-
Severe AEn=1461 Participants88-
Secondary/protocol endpoint

Number Participants With Serious Adverse Events (SAEs) and Deaths

Time frame:Up to 76 Weeks

event count, event

Secondary/protocol endpoint

Number of Participants With Adverse Event of Oedema

Time frame:Up to 76 Weeks

event count, event

Secondary/protocol endpoint

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

Time frame:Up to 70 Weeks (including follow up)

change from baseline, event

Secondary/protocol endpoint

Change From Baseline in Vital Sign Heart Rate (HR)

Time frame:Up to 70 Weeks (including follow up)

change from baseline, event

Secondary/protocol endpoint

Change From Baseline in Vital Sign Body Weight (BW)

Time frame:Up to 70 Weeks (including follow up)

change from baseline, event

Secondary/protocol endpoint

Number of Participants With SBP and DBP Values of Potential Clinical Concern (PCC)

Time frame:Up to 70 Weeks (including follow up)

change from baseline, event

Secondary/protocol endpoint

Number of Participants With HR Values of PCC ATOT

Time frame:Up to 70 Weeks (including follow up)

change from baseline, event

Secondary/protocol endpoint

Number of Participants With BW Values of PCC ATOT

Time frame:Up to 70 Weeks (including follow up)

threshold achievement, event

Secondary/registry result

Number Participants With Serious Adverse Events (SAEs) and Deaths

Time frame:Up to 76 Weeks

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
RSG XRAny SAEn=1461 Participants126-
Deathsn=1461 Participants20-
Secondary/registry result

Number of Participants With Adverse Event of Oedema

Time frame:Up to 76 Weeks

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
RSG XROedema peripheraln=1461 Participants130-
Face oedeman=1461 Participants8-
Pitting oedeman=1461 Participants5-
Oedeman=1461 Participants3-
Pulmonary oedeman=1461 Participants1-
Eyelid oedeman=1461 Participants1-
Secondary/registry result

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

Time frame:Up to 70 Weeks (including follow up)

change from baseline, event

Posted result

GroupValue (mean), millimeters of mercury (mmHg)Standard deviation
RSG XRSBP at Week 4n=1395 Participants-1.414.10
SBP at Week 8n=1274 Participants-2.414.73
SBP at Week 12n=1146 Participants-2.714.73
SBP at Week 16n=1061 Participants-3.715.02
SBP at Week 24n=892 Participants-2.115.51
SBP at Week 36n=666 Participants-1.415.14
SBP at Week 52n=251 Participants-1.716.18
SBP at Week 64n=15 Participants-2.213.78
SBP at Follow-upn=1280 Participants-1.815.60
DBP at Week 4n=1395 Participants-1.49.41
DBP at Week 8n=1274 Participants-2.09.53
DBP at Week 12n=1146 Participants-2.19.74
DBP at Week 16n=1061 Participants-2.49.62
DBP at Week 24n=892 Participants-2.49.48
DBP at Week 36n=666 Participants-2.09.85
DBP at Week 52n=251 Participants-3.69.94
DBP at Week 64n=15 Participants-6.36.72
DBP at Follow-upn=1280 Participants-0.910.23
Secondary/registry result

Change From Baseline in Vital Sign Heart Rate (HR)

Time frame:Up to 70 Weeks (including follow up)

change from baseline, event

Posted result

GroupValue (mean), beats per minute (bpm)Standard deviation
RSG XRHR at Week 4n=1391 Participants1.08.95
HR at Week 8n=1271 Participants1.89.60
HR at Week 12n=1142 Participants1.69.77
HR at Week 16n=1061 Participants1.69.66
HR at Week 24n=888 Participants0.99.99
HR at Week 36n=665 Participants1.39.86
HR at Week 52n=251 Participants0.78.54
HR at Week 64n=15 Participants1.08.02
HR at Follow-upn=1276 Participants0.910.03
Secondary/registry result

Change From Baseline in Vital Sign Body Weight (BW)

Time frame:Up to 70 Weeks (including follow up)

change from baseline, event

Posted result

GroupValue (mean), kgStandard deviation
RSG XRBW at Week 4n=1391 Participants0.32.04
BW at Week 8n=1263 Participants0.62.45
BW at Week 12n=1139 Participants0.62.43
BW at Week 16n=1057 Participants0.73.53
BW at Week 24n=889 Participants0.62.95
BW at Week 36n=666 Participants1.04.08
BW at Week 52n=251 Participants1.23.82
BW at Week 64n=15 Participants1.42.52
BW at Follow-upn=1268 Participants0.53.15
Secondary/registry result

Number of Participants With SBP and DBP Values of Potential Clinical Concern (PCC)

Time frame:Up to 70 Weeks (including follow up)

change from baseline, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
RSG XRATOT,SBP(RR)>140 or <90n=1409 Participants520-
ATOT,SBP(IFB)>=40n=1409 Participants33-
ATOT,SBP(DFB)>=30n=1409 Participants179-
Follow up,SBP(RR)>140 or <90n=1280 Participants240-
Follow up,SBP(IFB)>=40n=1280 Participants13-
Follow up,SBP(DFB)>=30n=1280 Participants63-
ATOT,DBP(RR)>90 or<50n=1409 Participants141-
ATOT,DBP(IFB)>=30n=1409 Participants20-
ATOT,DBP(DFB)>= 20n=1409 Participants211-
Follow up,DBP(RR)>90 or<50n=1280 Participants54-
Follow up,DBP(IFB)>=30n=1280 Participants5-
Follow up, DBP(DFB)>= 20n=1280 Participants67-
Secondary/registry result

Number of Participants With HR Values of PCC ATOT

Time frame:Up to 70 Weeks (including follow up)

change from baseline, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
RSG XRATOT,HR (RR)>100 or <50n=1409 Participants55-
ATOT,HR (IFB)>=30n=1409 Participants25-
ATOT,HR (DFB)>=30n=1409 Participants14-
Follow up,HR (RR)>100 or <50n=1276 Participants18-
Follow up,HR (IFB)>=30n=1276 Participants11-
Follow up,HR (DFB)>=30n=1276 Participants6-
Secondary/registry result

Number of Participants With BW Values of PCC ATOT

Time frame:Up to 70 Weeks (including follow up)

threshold achievement, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
RSG XRATOT, BW(IFB)>=7 percentn=1408 Participants188-
ATOT, BW(DFB)>= 7 percentn=1408 Participants83-
Follow up, BW(IFB)>=7 percentn=1270 Participants90-
Follow up, BW(DFB)>= 7 percentn=1270 Participants51-

Other (unclassified)

6 endpoints
Secondary/protocol endpoint/low confidence

Change From Baseline in Non-fasting Measures of Lipid Metabolism Namely Total Cholesterol (TC), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides

Time frame:Up to 82 Weeks (including follow up)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Number of Participants With Hematology Parameters of PCC ATOT

Time frame:Up to Week 82 (including follow up)

event count, event

Secondary/protocol endpoint/low confidence

Number of Participants With Clinical Chemistry Parameters (Including Lipids) of PCC ATOT

Time frame:Up to Week 82 (including follow up)

event count, event

Secondary/registry result/low confidence

Change From Baseline in Non-fasting Measures of Lipid Metabolism Namely Total Cholesterol (TC), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides

Time frame:Up to 82 Weeks (including follow up)

change from baseline, improvement

Posted result

GroupValue (mean), millimole per litre (mmol/l)Standard deviation
RSG XRTC at Week 4n=1313 Participants0.0760.6828
TC at Week 16n=1038 Participants0.2010.8666
TC at Week 36n=639 Participants0.2460.9649
TC at Week 52n=234 Participants0.1741.1437
TC at Week 76n=2 Participants-0.7150.3041
TC at follow upn=888 Participants0.0930.9377
HDL at Week 4n=1313 Participants0.0070.2008
HDL at Week 16n=1036 Participants-0.0140.2427
HDL at Week 36n=639 Participants-0.0260.2487
HDL at Week 52n=234 Participants-0.0350.2512
HDL at Week 76n=1 Participants0.050NA
HDL at follow upn=887 Participants-0.0580.2605
LDL at Week 4n=1263 Participants0.0620.6207
LDL at Week 16n=1008 Participants0.2100.7782
LDL at Week 36n=623 Participants0.2810.8863
LDL at Week 52n=226 Participants0.2281.0563
LDL at Week 76n=1 Participants-0.200NA
LDL at follow upn=853 Participants0.1480.8336
Triglycerides at Week 4n=1313 Participants0.0040.7845
Triglycerides at Week 16n=1038 Participants-0.0250.8053
Triglycerides at Week 36n=639 Participants-0.0620.8053
Triglycerides at Week 52n=234 Participants-0.0920.8521
Triglycerides at Week 76n=2 Participants-0.1500.9758
Triglycerides at follow upn=888 Participants-0.0350.8295
Secondary/registry result/low confidence

Number of Participants With Hematology Parameters of PCC ATOT

Time frame:Up to Week 82 (including follow up)

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
RSG XRATOT, Eosinophils (high)n=1384 Participants2-
ATOT, Haematocrit (low)n=1385 Participants8-
Follow up, Haematocrit (low)n=910 Participants6-
ATOT, Haemoglobin (high)n=1385 Participants2-
ATOT, Haemoglobin (low)n=1385 Participants74-
Follow up, Hemoglobin (high)n=910 Participants2-
Follow up, Hemoglobin (low)n=910 Participants25-
ATOT, Lymphocytes (high)n=1384 Participants3-
ATOT, Lymphocytes (low)n=1384 Participants21-
Follow up, Lymphocytes (high)n=909 Participants3-
Follow up, Lymphocytes (low)n=909 Participants9-
ATOT, MCH (low)n=1211 Participants5-
Follow up, MCH (low)n=785 Participants1-
ATOT, MCV (low)n=1385 Participants1-
ATOT, monocytes (high)n=1384 Participants1-
ATOT, monocytes (low)n=1384 Participants61-
Follow up, monocytes (low)n=909 Participants23-
ATOT, platelet count (high)n=1381 Participants7-
ATOT, platelet count (low)n=1381 Participants5-
ATOT, RDW (high)n=1385 Participants158-
Follow up, RDW (high)n=910 Participants45-
ATOT, RBC (low)n=1385 Participants12-
Follow up, RBC (low)n=910 Participants4-
ATOT, SN (high)n=1384 Participants6-
ATOT, SN (low)n=1384 Participants15-
Follow up, SN (high)n=909 Participants3-
Follow up, SN (low)n=909 Participants3-
ATOT, TN (high)n=1384 Participants3-
ATOT, TN (low)n=1384 Participants15-
Follow up, TN (high)n=909 Participants2-
Follow up, TN (low)n=909 Participants3-
ATOT, WBC (high)n=1384 Participants5-
ATOT, WBC (low)n=1384 Participants22-
Follow up, WBC (high)n=909 Participants3-
Follow up, WBC (low)n=909 Participants11-
Secondary/registry result/low confidence

Number of Participants With Clinical Chemistry Parameters (Including Lipids) of PCC ATOT

Time frame:Up to Week 82 (including follow up)

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
RSG XRFollow up, ALT (high)n=908 Participants2-
Follow up, Albumin (low)n=909 Participants1-
ATOT, Aldolase (high)n=464 Participants16-
ATOT, Aldolase (low)n=464 Participants78-
Follow up, Aldolase (high)n=146 Participants3-
Follow up, Aldolase (low)n=146 Participants14-
ATOT, AST (high)n=1385 Participants2-
Follow up, AST (high)n=908 Participants3-
ATOT, BUN/creatinine ratio (high)n=1385 Participants87-
Follow up, BUN/creatinine ratio (high)n=908 Participants37-
ATOT, CO2 content (low)n=1384 Participants2-
Follow up, CO2 content (low)n=908 Participants3-
ATOT, chloride (high)n=1385 Participants1-
ATOT, cholesterol (high)n=1383 Participants175-
Follow up, cholesterol (high)n=907 Participants50-
ATOT, CK (high)n=1385 Participants131-
Follow up, CK (high)n=908 Participants40-
ATOT, Creatinine (high)n=1385 Participants27-
Follow up, creatinine (high)n=908 Participants10-
ATOT, DB (high)n=1385 Participants4-
ATOT, GGT (high)n=1385 Participants7-
Follow up, GGT (high)n=908 Participants2-
ATOT, Glucose (high)n=1385 Participants100-
ATOT, Glucose (low)n=1385 Participants40-
Follow up, glucose (high)n=908 Participants31-
Follow up, glucose (low)n=908 Participants13-
ATOT, HbA1c (high)n=742 Participants2-
ATOT, HDL (low)n=1383 Participants11-
Follow up, HDL (low)n=906 Participants7-
ATOT, LDL (low)n=1368 Participants469-
Follow up, LDL (low)n=888 Participants211-
ATOT, LD (high)n=1384 Participants1-
Follow up, LD (high)n=909 Participants1-
ATOT, Magnesium (low)n=1385 Participants1-
Follow up, Magnesium (low)n=909 Participants1-
ATOT, Potassium (high)n=1384 Participants17-
ATOT, Potassium (low)n=1384 Participants1-
Follow up, Potassium (high)n=909 Participants2-
Follow up, Potassium (low)n=909 Participants1-
ATOT, Sodium (high)n=1385 Participants2-
ATOT, Sodium (low)n=1385 Participants4-
Follow up, Sodium (low)n=909 Participants1-
ATOT, TB (high)n=1386 Participants1-
Follow up, TB (high)n=908 Participants1-
ATOT, Triglycerides (high)n=1383 Participants1-
ATOT, Troponin I (high)n=426 Participants13-
Follow up, Troponin I (high)n=142 Participants2-
ATOT, Urea (high)n=1385 Participants97-
Follow up, Urea (high)n=909 Participants42-

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

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.