NCT00381238 is a Phase 2 clinical trial of rosiglitazone in Alzheimer's Disease, sponsored by GlaxoSmithKline.

Who is sponsoring NCT00381238?

NCT00381238 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00381238?

Interventions in NCT00381238: rosiglitazone.

What condition does NCT00381238 study?

NCT00381238 studies Alzheimer's Disease.

Is NCT00381238 still recruiting?

NCT00381238 is currently completed. Last updated 23 May 2017.

Are results published for NCT00381238?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-05-23 · How we verify

NCT00381238

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 23 May 2017

What this trial tests

Phase 2 trial testing rosiglitazone in Alzheimer's Disease in 33 participants. Completed in 3 February 2009.

Timeline

20 June 2006

Primary endpoint
1 February 2009

3 February 2009

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	33
Start date	20 June 2006
Primary completion	1 February 2009
Estimated completion	3 February 2009
Sites	7 locations across Canada, United States

Drugs / interventions tested

rosiglitazone (ROSIGLITAZONE) — full drug profile →

Conditions studied

Alzheimer's Disease — all drugs for Alzheimer's Disease →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 50 to 85, any sex, with Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events (AE's) Primary · From start of study medication (Wk 0) to Wk 50

An AE was defined as any untoward medical occurrence or clinical investigation in a participant, temporally associated with the use of a medicinal product, whether or not, considered related to the medicinal product. For marketed medicinal products, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The number of participants with all AEs, drug related AEs, serious adverse events (SAEs), AE leading to permanent (prm) discontinuation (disc) of study drug or withdrawal were reported.

All AEs

Group	Value	95% CI
RSG XR, 8 mg	25

SAEs

Group	Value	95% CI
RSG XR, 8 mg	2

Drug related AEs

Group	Value	95% CI
RSG XR, 8 mg	8

AE leading to prm disc of study drug or withdrawal

Group	Value	95% CI
RSG XR, 8 mg	3

Mean Change From Baseline in Mini Mental State Examination (MMSE) Total Score Secondary · From baseline to Wk 48

The MMSE, is a score scale which consists of 11 tests of orientation (to time and place), memory (recent and immediate), concentration, language and praxis. The scoring ranged from 0 to 30, with lower scores indicative of greater cognitive impairment (more severe disease) and higher scores indicative less cognitive impairment (less severe disease). The total score was calculated by summing the scores from each of the tests. The investigator questioned the participants individually with set of questions and scored the participant, based on his performance. The baseline was defined as Wk 0. The

Group	Value	95% CI
RSG XR, 8 mg	-4.5	± 4.07

Number of Participants With SAEs Secondary · From start of study medication (Wk 0) to Wk 50

An SAE, is any untoward medical occurrence, that at any dose may result in death, is life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability or incapacity, is congenital anomaly or birth defect, and medically important events. The number of participants with any SAE, were reported.

Group	Value	95% CI
RSG XR, 8 mg	2

Number of Participants With AE of Peripheral Edema by Grade Secondary · Up to Wk 50

Participants with AE of peripheral edema were evaluated. The test was performed by firmly pressing the thumb anterior to the participants ankle until further pressure produced no greater indentation. The depth of the pit was estimated and it was graded using below 5 point scale; where estimated depth of indentation corresponded to a particular grade (G). G 0 as depth of \<1 millimeter (mm); G1 as depth of 1-2 mm; G2 as depth of 3-5 mm; G3 as depth of 6-10 mm; and G4 as depth of \> 10 mm. The data for only the participants who had peripheral edema on more than one visit, then their most severe

Participants with G0 peripheral edema

Group	Value	95% CI
RSG XR, 8 mg	28

Participants with G1 peripheral edema

Group	Value	95% CI
RSG XR, 8 mg	3

Participants with G2 peripheral edema

Group	Value	95% CI
RSG XR, 8 mg	2

Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure Secondary · Baseline (Wk 0) to Wk 50

Participants systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured in mm of mercury (mmHg). These were collected after the participant sat quietly for at least five minutes. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values.

DBP, Wk 2

Group	Value	95% CI
RSG XR, 8 mg	-1.1	± 8.31

SBP, Wk 2

Group	Value	95% CI
RSG XR, 8 mg	1.7	± 14.56

DBP, Wk 4

Group	Value	95% CI
RSG XR, 8 mg	-1.8	± 9.25

SBP, Wk 4

Group	Value	95% CI
RSG XR, 8 mg	-1.3	± 12.91

DBP, Wk 8

Group	Value	95% CI
RSG XR, 8 mg	0.3	± 8.19

SBP, Wk 8

Group	Value	95% CI
RSG XR, 8 mg	3.2	± 12.96

DBP, Wk 16

Group	Value	95% CI
RSG XR, 8 mg	-2.0	± 9.69

SBP, Wk 16

Group	Value	95% CI
RSG XR, 8 mg	-1.4	± 13.94

Mean Change From Baseline in Vital Signs-heart Rate (HR) Secondary · Baseline (Wk 0) to Wk 50

The HR for the participant's, were collected after the participant sat quietly for at least five minutes. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. The HR was measured in beats per minute (bpm).

HR, Wk 2

Group	Value	95% CI
RSG XR, 8 mg	1.8	± 5.70

HR, Wk 4

Group	Value	95% CI
RSG XR, 8 mg	1.2	± 10.20

HR, Wk 8

Group	Value	95% CI
RSG XR, 8 mg	1.0	± 12.72

HR, Wk 16

Group	Value	95% CI
RSG XR, 8 mg	0.3	± 12.53

HR, Wk 24

Group	Value	95% CI
RSG XR, 8 mg	1.5	± 13.24

HR, Wk 32

Group	Value	95% CI
RSG XR, 8 mg	-0.2	± 12.34

HR, Wk 40

Group	Value	95% CI
RSG XR, 8 mg	1.9	± 15.29

HR, Wk 48

Group	Value	95% CI
RSG XR, 8 mg	0.1	± 7.57

Number of Participants With Vital Signs of Clinical Concern. Secondary · Up to Wk 50

The data for number of participants with vital sign data, outside the range of potential clinical concern for SBP, DBP, HR and body weight were reported. The values as of potential clinical concern were 'both' outside of reference range or met a change from baseline criterion. The RR, for SBP was 90-140 mmHg for which the increase from baseline was reported to be \>= 40 mmHg and decrease from baseline reported as \>=30 mmHg; the RR for DBP was 50-90 mmHg for which the increase from baseline was reported to be \>= 30 mmHg and decrease from baseline reported as \>=20 mmHg; and the RR, for HR was

DBP >CCR, Wk 0

Group	Value	95% CI
RSG XR, 8 mg	1

DBP <CCR, Wk 4

Group	Value	95% CI
RSG XR, 8 mg	1

DBP >CCR, Wk 24

Group	Value	95% CI
RSG XR, 8 mg	1

DBP <CCR, Wk 48

Group	Value	95% CI
RSG XR, 8 mg	1

SBP >CCR, Wk 0

Group	Value	95% CI
RSG XR, 8 mg	4

SBP <CCR, Wk 0

Group	Value	95% CI
RSG XR, 8 mg	1

SBP >CCR, Wk 2

Group	Value	95% CI
RSG XR, 8 mg	5

SBP >CCR, Wk 4

Group	Value	95% CI
RSG XR, 8 mg	4

Mean Change From Baseline in Vital Signs- Weight Secondary · Baseline (Wk 0) to Wk 50

The weight for the participant, was measured without wearing shoes and with light clothing. There was no particular RR, reported for weight; however, the increase from baseline was reported to be \>=7 % and the decrease also reported as \>=7 %. The values as of potential clinical concern were 'both' outside of RR, or met a change from baseline criterion.

Weight, Wk 2

Group	Value	95% CI
RSG XR, 8 mg	-0.4	± 1.42

Weight, Wk 4

Group	Value	95% CI
RSG XR, 8 mg	-0.0	± 1.93

Weight, Wk 8

Group	Value	95% CI
RSG XR, 8 mg	0.3	± 2.12

Weight, Wk 16

Group	Value	95% CI
RSG XR, 8 mg	0.2	± 3.18

Weight, Wk 24

Group	Value	95% CI
RSG XR, 8 mg	0.3	± 3.21

Weight, Wk 32

Group	Value	95% CI
RSG XR, 8 mg	0.3	± 3.97

Weight, Wk 40

Group	Value	95% CI
RSG XR, 8 mg	0.4	± 3.25

Weight, Wk 48

Group	Value	95% CI
RSG XR, 8 mg	0.0	± 2.91

Number of Participants With Clinical Chemistry Parameters of Clinical Concern Secondary · Up to Wk 50

The data for participants for clinical parameters, with values only of potential clinical concern (PCI) were reported for creatine, creatinine kinase(CK), urea and glucose. Creatinine(unit: micromoles per litre) : low concern and high concern values were considered as 22 absolute value (AB) (\<50% lower limit of RR ) and 155 (AB) (\>125% upper limit of RR) respectively. CK (unit: international unit per litre ): low concern value and high concern values was none and 1.25 respectively. Glucose (unit: millimole per litre): low concern and high concern values were considered as 3.6 (AB) and 7.8 (A

CK, Wk 8, normal

Group	Value	95% CI
RSG XR, 8 mg	0

CK, Wk 8, high

Group	Value	95% CI
RSG XR, 8 mg	1

CK, Wk 16, normal

Group	Value	95% CI
RSG XR, 8 mg	0

CK, Wk 16, high

Group	Value	95% CI
RSG XR, 8 mg	1

CK, Wk 24, normal

Group	Value	95% CI
RSG XR, 8 mg	0

CK, Wk 24, high

Group	Value	95% CI
RSG XR, 8 mg	1

CK, Wk 32, normal

Group	Value	95% CI
RSG XR, 8 mg	0

CK, Wk 32, high

Group	Value	95% CI
RSG XR, 8 mg	1

Number of Participant's With Hematology Parameters of Clinical Concern Secondary · Up to Wk 50

Participant data for clinical concern hematology parameters, were reported for hematocrit (Hct) (unit:1): low concern (LC) and high concern (HC) values as 0.8 and 1.2 respectively, hemoglobin (Hb) (unit: gram per deciliter): LC and HC values as value for female (F) 10 (AB) , value for male (M) 11; and value for F 16.5 (AB), value for M 18 respectively; lymphocytes absolute(LA) (unit: giga cells per litre \[GI/L\]) : LC and HC value as 0.75 and 1.5 respectively; monocytes absolute (MA) (unit: GI/L) LC and HC value as 0.75 and 2 respectively, platelet count (PC) (unit: x103/mm3): LC and HC value

Hct, Wk 32, normal

Group	Value	95% CI
RSG XR, 8 mg	0

Hct, Wk 32, high

Group	Value	95% CI
RSG XR, 8 mg	0

Hct, Wk 32, low

Group	Value	95% CI
RSG XR, 8 mg	1

Hb, Wk 8, normal

Group	Value	95% CI
RSG XR, 8 mg	0

Hb, Wk 8, high

Group	Value	95% CI
RSG XR, 8 mg	0

Hb, Wk 8, low

Group	Value	95% CI
RSG XR, 8 mg	1

Hb, Wk 24, normal

Group	Value	95% CI
RSG XR, 8 mg	0

Hb, Wk 24, high

Group	Value	95% CI
RSG XR, 8 mg	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From start of study medication (Wk 0) to Wk 50. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

RSG XR, 8 MG

Serious: 2/33 (6%)

Deaths: 0/33

Serious adverse events (3 terms)

Reaction	System	RSG XR, 8 MG
Fall	Injury, poisoning and procedural complications	—
Pelvic fracture	Injury, poisoning and procedural complications	—
Convulsion	Nervous system disorders	—

Other adverse events (5 terms — click to expand)

Reaction	System	RSG XR, 8 MG
Oedema peripheral	General disorders	—
Bursitis	Musculoskeletal and connective tissue disorders	—
Fall	Injury, poisoning and procedural complications	—
Haematoma	Vascular disorders	—
Vomiting	Gastrointestinal disorders	—

Most-reported serious reactions: Fall, Pelvic fracture, Convulsion.

Data from ClinicalTrials.gov NCT00381238 adverse events section.

Sponsor's own description

This is 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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Exploration and Development of PPAR Modulators in Health and Disease: An Update of Clinical Evidence.
Cheng HS, Tan WR, Low ZS, Marvalim C, et al · · 2019 · cited 196× · PMID 31614690 · DOI 10.3390/ijms20205055
PPARγ/PGC1α signaling as a potential therapeutic target for mitochondrial biogenesis in neurodegenerative disorders.
Jamwal S, Blackburn JK, Elsworth JD. · · 2021 · cited 189× · PMID 33039420 · DOI 10.1016/j.pharmthera.2020.107705
Sulfur-containing therapeutics in the treatment of Alzheimer's disease.
Zhu H, Dronamraju V, Xie W, More SS. · · 2021 · cited 25× · PMID 33613018 · DOI 10.1007/s00044-020-02687-1
Exercise mimetics: molecular mechanisms, biological and therapeutic effects.
Zhang J, Shao Q, Cheng T, Lin J, et al · · 2026 · PMID 42234316 · DOI 10.1186/s43556-026-00483-8

Verify or expand the search:

Other trials of rosiglitazone

Trials testing the same drug.

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NCT00427154 — Effect of Inhaled Pre-prandial Human Insulin on Blood Glucose Control in Type 2 Diabetes · Phase 3 · terminated
NCT00348712 — Efficacy and Safety of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes · Phase 3 · terminated
NCT00343980 — Safety and Efficacy of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes · Phase 3 · terminated
NCT00350779 — Sitagliptin Metformin/PPARg Agonist Combination Therapy Add-on (0431-052) · Phase 3 · completed

Other recruiting trials for Alzheimer's Disease

Currently open trials in the same condition.

NCT07457138 — Lombard Cohort of Brain Health Services · recruiting
NCT07234942 — A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants Wit · Phase 1 · recruiting
NCT07479914 — Art of Memory for Cognitive Enhancement in the Monza Brain Health Service · NA · active not recruiting
NCT07214727 — A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease · Phase 1 · recruiting
NCT07105709 — Open-label Extension Study in Participants With Early Alzheimer's Disease · Phase 2 · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00381238 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 23 May 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00381238.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing