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CompletedPhase 2Results posted

Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease

An Open-label Extension to Study 49653/461, to Assess the Long-term Safety of Rosiglitazone (Extended Release Tablets) in Subjects With Mild to Moderate Alzheimer's Disease

Lead sponsor

GlaxoSmithKline

Asset

Rosiglitazone

Listed sites

7

Recruiting sites

-

Enrollment

33

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Study partner/caregiver required

Primary endpoint

•Adverse Events (AE's)

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 IDAVA104617
NCT IDNCT00381238

Timeline

Milestones

Study start2006-06-20
Study first posted2006-09-27estimated
Primary completion2009-02-01actual
Study completion2009-02-03actual
Last update posted2017-05-23actual
Results first posted2017-05-23actual

Assets

Drug assets

Rosiglitazone

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female subject who has successfully completed the 12 Month Visit of 49653/461 (12 months of treatment) without tolerability issues, where in the opinion of the subject and of the investigator, it will be beneficial to continue treatment with RSG XR.
•Female subjects must be post-menopausal (i.e. >6 months without menstrual period), surgically sterile, or if of child-bearing potential, using effective contraceptive measures (oral contraceptives, Norplant, Depo-Provera, an intra-uterine device (IUD) a diaphragm with spermicide or a condom with spermicide). Women of childbearing potential must use effective contraceptive measures throughout the study and for 30 days after discontinuing study medication. The subject and their caregiver must ensure that the subject will continuously use contraceptive measures throughout the duration of the study.
•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[1].[1] Where this is in accordance with local laws, regulations and ethics committee policy.
•Caregiver has provided full written informed consent on his or her own behalf prior to the performance of any protocol-specified procedure

Exclusion criteria

•Subject had a serious adverse experience (SAE) or clinically significant laboratory abnormality during 49653/461, which in the opinion of the investigator could have been attributable to study medication, and which is ongoing at the end of 49653/461.
•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 based on the entry criteria for the primary study, 49653/461 (exclusive of the age criteria which may not be applicable to some of the subjects).
•The subject experienced a significant cardiovascular event during 49653/461 (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.
•Treatment with a cholinesterase inhibitor, selegiline, memantine or any other treatment for cognitive symptoms/AD is initiated at the end of 49653/461.

Endpoints (22)

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
12
Other (unclassified)
8
Global cognition
2

Global cognition

2 endpoints
Secondary/protocol endpoint

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

Time frame:From baseline to Wk 48

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

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

Time frame:From baseline to Wk 48

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

GroupValue (mean), score on scaleStandard deviation
RSG XR, 8 mgn=21 Participants-4.54.07

Safety / tolerability / PK

12 endpoints
Primary/protocol endpoint

Number of Participants With Adverse Events (AE's)

Time frame:From start of study medication (Wk 0) to Wk 50

event count, event

Primary/registry result

Number of Participants With Adverse Events (AE's)

Time frame:From start of study medication (Wk 0) to Wk 50

event count, event

Posted result

GroupValue (number), participantsReported bounds
RSG XR, 8 mgAll AEsn=33 Participants25-
SAEsn=33 Participants2-
Drug related AEsn=33 Participants8-
AE leading to prm disc of study drug or withdrawaln=33 Participants3-
Secondary/protocol endpoint

Number of Participants With SAEs

Time frame:From start of study medication (Wk 0) to Wk 50

event count, event

Secondary/protocol endpoint

Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure

Time frame:Baseline (Wk 0) to Wk 50

change from baseline, event

Secondary/protocol endpoint

Mean Change From Baseline in Vital Signs-heart Rate (HR)

Time frame:Baseline (Wk 0) to Wk 50

change from baseline, event

Secondary/protocol endpoint

Number of Participants With Vital Signs of Clinical Concern.

Time frame:Up to Wk 50

change from baseline, event

Secondary/protocol endpoint

Mean Change From Baseline in Vital Signs- Weight

Time frame:Baseline (Wk 0) to Wk 50

change from baseline, event

Secondary/registry result

Number of Participants With SAEs

Time frame:From start of study medication (Wk 0) to Wk 50

event count, event

Posted result

GroupValue (number), participantsReported bounds
RSG XR, 8 mgn=33 Participants2-
Secondary/registry result

Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure

Time frame:Baseline (Wk 0) to Wk 50

change from baseline, event

Posted result

GroupValue (mean), mmHgStandard deviation
RSG XR, 8 mgDBP, Wk 2n=27 Participants-1.18.31
SBP, Wk 2n=27 Participants1.714.56
DBP, Wk 4n=32 Participants-1.89.25
SBP, Wk 4n=32 Participants-1.312.91
DBP, Wk 8n=32 Participants0.38.19
SBP, Wk 8n=32 Participants3.212.96
DBP, Wk 16n=30 Participants-2.09.69
SBP, Wk 16n=30 Participants-1.413.94
DBP, Wk 24n=28 Participants-2.610.22
SBP, Wk 24n=28 Participants3.217.96
DBP, Wk 32n=24 Participants-0.97.96
SBP, Wk 32n=24 Participants4.712.59
DBP, Wk 40n=23 Participants-2.710.10
SBP, Wk 40n=23 Participants1.613.96
DBP, Wk 48n=21 Participants-3.710.13
SBP, Wk 48n=21 Participants1.013.72
Secondary/registry result

Mean Change From Baseline in Vital Signs-heart Rate (HR)

Time frame:Baseline (Wk 0) to Wk 50

change from baseline, event

Posted result

GroupValue (mean), bpmStandard deviation
RSG XR, 8 mgHR, Wk 2n=27 Participants1.85.70
HR, Wk 4n=32 Participants1.210.20
HR, Wk 8n=32 Participants1.012.72
HR, Wk 16n=30 Participants0.312.53
HR, Wk 24n=28 Participants1.513.24
HR, Wk 32n=24 Participants-0.212.34
HR, Wk 40n=23 Participants1.915.29
HR, Wk 48n=21 Participants0.17.57
Secondary/registry result

Number of Participants With Vital Signs of Clinical Concern.

Time frame:Up to Wk 50

change from baseline, event

Posted result

GroupValue (number), participantsReported bounds
RSG XR, 8 mgDBP >CCR, Wk 0n=33 Participants1-
DBP <CCR, Wk 4n=32 Participants1-
DBP >CCR, Wk 24n=28 Participants1-
DBP <CCR, Wk 48n=21 Participants1-
SBP >CCR, Wk 0n=33 Participants4-
SBP <CCR, Wk 0n=33 Participants1-
SBP >CCR, Wk 2n=27 Participants5-
SBP >CCR, Wk 4n=32 Participants4-
SBP <CCR, Wk 4n=32 Participants1-
SBP >CCR, Wk 8n=32 Participants5-
SBP >CCR, Wk 16n=30 Participants1-
SBP >CCR, Wk 24n=28 Participants3-
SBP >CCR, Wk 32n=24 Participants5-
SBP >CCR, Wk 40n=23 Participants7-
SBP >CCR, Wk 48n=21 Participants1-
HR >CCR, Wk 0n=33 Participants1-
HR <CCR, Wk 4n=32 Participants1-
HR <CCR, Wk 8n=32 Participants1-
HR <CCR, Wk 16n=30 Participants1-
HR >CCR, Wk 40n=23 Participants1-
HR <CCR, Wk 40n=23 Participants1-
Secondary/registry result

Mean Change From Baseline in Vital Signs- Weight

Time frame:Baseline (Wk 0) to Wk 50

change from baseline, event

Posted result

GroupValue (mean), kilogramsStandard deviation
RSG XR, 8 mgWeight, Wk 2n=27 Participants-0.41.42
Weight, Wk 4n=32 Participants-0.01.93
Weight, Wk 8n=32 Participants0.32.12
Weight, Wk 16n=30 Participants0.23.18
Weight, Wk 24n=28 Participants0.33.21
Weight, Wk 32n=24 Participants0.33.97
Weight, Wk 40n=23 Participants0.43.25
Weight, Wk 48n=21 Participants0.02.91

Other (unclassified)

8 endpoints
Secondary/protocol endpoint/low confidence

Number of Participants With AE of Peripheral Edema by Grade

Time frame:Up to Wk 50

event count, event

Secondary/protocol endpoint/low confidence

Number of Participants With Clinical Chemistry Parameters of Clinical Concern

Time frame:Up to Wk 50

event count, event

Secondary/protocol endpoint/low confidence

Number of Participants With Clinical Chemistry Parameters of Clinical Concern-lipids

Time frame:Up to Wk 50

event count, event

Secondary/protocol endpoint/low confidence

Number of Participant's With Hematology Parameters of Clinical Concern

Time frame:Up to Wk 50

event count, event

Secondary/registry result/low confidence

Number of Participants With AE of Peripheral Edema by Grade

Time frame:Up to Wk 50

event count, event

Posted result

GroupValue (number), participantsReported bounds
RSG XR, 8 mgParticipants with G0 peripheral edeman=33 Participants28-
Participants with G1 peripheral edeman=33 Participants3-
Participants with G2 peripheral edeman=33 Participants2-
Secondary/registry result/low confidence

Number of Participants With Clinical Chemistry Parameters of Clinical Concern

Time frame:Up to Wk 50

event count, event

Posted result

GroupValue (number), participantsReported bounds
RSG XR, 8 mgCK, Wk 8, normaln=20 Participants0-
CK, Wk 8, highn=20 Participants1-
CK, Wk 16, normaln=21 Participants0-
CK, Wk 16, highn=21 Participants1-
CK, Wk 24, normaln=26 Participants0-
CK, Wk 24, highn=26 Participants1-
CK, Wk 32, normaln=21 Participants0-
CK, Wk 32, highn=21 Participants1-
CK, Wk 40, normaln=23 Participants0-
CK, Wk 40, highn=23 Participants2-
Creatinine, Wk 8, normaln=20 Participants0-
Creatinine, Wk 8, highn=20 Participants1-
Creatinine, Wk 8, lown=20 Participants0-
Creatinine, Wk 16, normaln=21 Participants0-
Creatinine, Wk 16, highn=21 Participants2-
Creatinine, Wk 16, lown=21 Participants0-
Creatinine, Wk 24, normaln=26 Participants0-
Creatinine,Wk 24, highn=26 Participants1-
Creatinine, Wk 24, lown=26 Participants0-
Creatinine, Wk 32, normaln=21 Participants0-
Creatinine,Wk 32, highn=21 Participants1-
Creatinine, Wk 32, lown=21 Participants0-
Glucose, Wk 0, normaln=19 Participants0-
Glucose, Wk 0, highn=19 Participants1-
Glucose, Wk 0, lown=19 Participants0-
Urea, Wk 0, normaln=11 Participants0-
Urea, Wk 0, highn=11 Participants1-
Secondary/registry result/low confidence

Number of Participants With Clinical Chemistry Parameters of Clinical Concern-lipids

Time frame:Up to Wk 50

event count, event

Secondary/registry result/low confidence

Number of Participant's With Hematology Parameters of Clinical Concern

Time frame:Up to Wk 50

event count, event

Posted result

GroupValue (number), participantReported bounds
RSG XR, 8 mgHct, Wk 32, normaln=21 Participants0-
Hct, Wk 32, highn=21 Participants0-
Hct, Wk 32, lown=21 Participants1-
Hb, Wk 8, normaln=28 Participants0-
Hb, Wk 8, highn=28 Participants0-
Hb, Wk 8, lown=28 Participants1-
Hb, Wk 24, normaln=28 Participants0-
Hb, Wk 24, highn=28 Participants0-
Hb, Wk 24, lown=28 Participants1-
Hb, Wk 32, normaln=21 Participants0-
Hb, Wk 32, highn=21 Participants0-
Hb, Wk 32, lown=21 Participants1-
Hb, Wk 40, normaln=23 Participants0-
Hb, Wk 40, highn=23 Participants0-
Hb, Wk 40, lown=23 Participants1-
Hb,Wk 48, normaln=19 Participants0-
Hb, Wk 48, highn=19 Participants0-
Hb,Wk 48, lown=19 Participants1-
LA, Wk 8, normaln=28 Participants0-
LA, Wk 8, highn=28 Participants0-
LA, Wk 8, lown=28 Participants1-
LA, Wk 24, normaln=28 Participants0-
LA, Wk 24, highn=28 Participants0-
LA, Wk 24, lown=28 Participants1-
MA, Wk 0, normal,n=19 Participants0-
MA, Wk 0, highn=19 Participants0-
MA, Wk 0, lown=19 Participants1-
MA, Wk 24, normaln=28 Participants0-
MA, Wk 24, highn=28 Participants0-
MA, Wk 24, lown=28 Participants2-
MA, Wk 40, normaln=23 Participants0-
MA, Wk 40, highn=23 Participants0-
MA, Wk 40, lown=23 Participants2-
PC, Wk 8, normaln=28 Participants0-
PC, Wk 8, highn=28 Participants0-
PC, Wk 8, lown=28 Participants2-
PC, Wk 32, normaln=21 Participants0-
PC, Wk 32, highn=21 Participants0-
PC, Wk 32, lown=21 Participants1-
PC, Wk 40, normaln=23 Participants0-
PC, Wk 40, highn=23 Participants0-
PC, Wk 40, lown=23 Participants1-
PC, Wk 48, normaln=19 Participants0-
PC, Wk 48, highn=19 Participants0-
PC, Wk 48, lown=19 Participants1-
RBC, Wk 32, normaln=21 Participants0-
RBC, Wk 32, highn=21 Participants0-
RBC, Wk 32, lown=21 Participants1-
SNP, Wk 8, normaln=28 Participants0-
SNP, Wk 8, highn=28 Participants0-
SNP, Wk 8, lown=28 Participants1-
SNP, Wk 24, normaln=28 Participants0-
SNP, Wk 24, highn=28 Participants0-
SNP, Wk 24, lown=28 Participants1-
TNA, Wk 8, normaln=28 Participants0-
TNA, Wk 8, highn=28 Participants0-
TNA, Wk 8, lown=28 Participants1-
TNA, Wk 24, normaln=28 Participants0-
TNA, Wk 24, highn=28 Participants0-
TNA, Wk 24, lown=28 Participants1-
WBC, Wk 8, normaln=28 Participants0-
WBC, Wk 8, highn=28 Participants0-
WBC, Wk 8, lown=28 Participants2-
WBC, Wk 16, normaln=31 Participants0-
WBC, Wk 16, highn=31 Participants0-
WBC, Wk 16, lown=31 Participants2-

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.