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

• ClinicalTrials.gov Identifier: NCT00550420
• Recruitment Status: Terminated
• First Posted: October 29, 2007
• Results First Posted: November 8, 2017
• Last Update Posted: November 8, 2017
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

Brief Summary:

This is a Phase III, multicenter, open-label extension, single-group study in male and female outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed AVA105640. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg once daily for the first 4 weeks of the study followed by 8mg RSG XR. Subject participation will last until one of 5 conditions applies. After a 52-week open-label treatment phase, subjects will attend a final Follow-Up Visit 6 weeks after the end of treatment. The primary objective of this study is to evaluate the long-term safety and tolerability of RSG XR in subjects with mild-to-moderate AD who have completed AVA105640. The secondary objective of this study is to explore further the long-term efficacy of RSG XR in terms of cognitive function and overall clinical response as a function of apolipoprotein E (APOE) e4 allele status

Condition or disease	Intervention/treatment	Phase
Alzheimer's Disease	Drug: Rosiglitazone XR	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 331 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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.
• Actual Study Start Date: October 1, 2007
• Actual Primary Completion Date: February 12, 2009
• Actual Study Completion Date: February 12, 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm 1; Rosiglitazone XR	Drug: Rosiglitazone XR; experimental drug

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Any Adverse Events (AEs) and Severity of AEs [ Time Frame: Up to Week 82 ]
   AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The drug related-AEs of special interest (AESI) was reported. The severity of the AESI was categorized as mild, moderate and severe. Number of participants with AEs were reported for treatment duration of the study.

Secondary Outcome Measures :

1. Number of Participants With Serious AEs and Deaths [ Time Frame: Up to Week 82 ]
   A serious adverse event is defined as any untoward medical occurrence that, at any dose results in death, life-threatening condition, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or a congenital anomaly or birth defect. The SAEs and deaths are reported from Visit 1 (W0) till end of the follow-up period (W110)
2. Percentage of Participants With AEs of Edema [ Time Frame: Up to 82 Weeks ]
   Edema was considered as adverse event of special interest (AESI). The process for AESI selection was based on RSG's pharmacologic class and relevant AEs potentially associated with RSG. Percentage of participants reported with edema as AESI were reported.
3. 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) ]
   SBP and DBP of participant were recorded in sitting posture as vital sign at each visit. The blood pressure (BP) values were identified as of potential clinical concern if the vales were out of the reference range (for SBP, 90 to 140 mmHg and DBP, 50 to 90 mmHg) or meet a change from Baseline criterion. The change from Baseline criterion for SBP, was increase from Baseline (high) if increased by more than or equal to (>=) 40 mmHg from Baseline; decrease from Baseline (low) if decreased by >= 30 mmHg from Baseline. For DBP, increase form Baseline (high) if increased by >= 30 mmHg from Baseline; decrease from Baseline (low) if decreased by >= 20 mmHg from Baseline. The Baseline assessments were referred to assessments at Visit 1 (W 0). Change from Baseline was measured as the blood pressure value recorded at specified visit minus the Baseline value.
4. 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) ]
   HR of participants was recorded as vital sign at each visit. The HR values were identified as of potential clinical concern if the vales were out of the reference range 50 to 100 beats per minute (BPM) or meet a change from Baseline criterion. The change from Baseline criterion was as, increase in HR (high) from Baseline if HR was increased by >= 30 bpm or decrease in HR (Low) from Baseline if HR was decreased by >= 30 bpm from Baseline. The Baseline assessments were referred to assessments at Visit 1 (W 0). Change from Baseline was measured as the HR at specified visit minus the Baseline value.
5. Number of Participants With Abnormal SBP and DBP at Any Time During Treatment Period [ Time Frame: Up to 82 weeks ]
   SBP and DBP of participant were recorded in sitting posture as vital sign at each visit. The blood pressure (BP) values were identified as of potential clinical concern if the vales were out of the reference range (for SBP, 90 to 140 mmHg and DBP, 50 to 90 mmHg) or meet a change from Baseline criterion. The change from Baseline criterion for SBP, was increase from Baseline (high) if increased by more than or equal to (>=) 40 mmHg from Baseline; decrease from Baseline (low) if decreased by >= 30 mmHg from Baseline. For DBP, increase form Baseline (high) if increased by >= 30 mmHg from Baseline; decrease from Baseline (low) if decreased by >= 20 mmHg from Baseline. The Baseline assessments were referred to assessments at Visit 1 (W 0). Change from Baseline was measured as the blood pressure value recorded at specified visit minus the Baseline value.
6. Number of Participants With Abnormal HR at Any Time During Treatment Period [ Time Frame: Up to 82 weeks ]
   HR of participants was recorded as vital sign at each visit. The HR values were identified as of potential clinical concern if the vales were out of the reference range 50 to 100 beats per minute (BPM) or meet a change from Baseline criterion. The change from Baseline criterion was as, increase in HR (high) from Baseline if HR was increased by >= 30 bpm or decrease in HR (Low) from Baseline if HR was decreased by >= 30 bpm from Baseline. The Baseline assessments were referred to assessments at Visit 1 (W 0). Change from Baseline was measured as the HR at specified visit minus the Baseline value. Number of participants with abnormal HR at any time during treatment period were reported.
7. 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) ]
   BW of participants were recorded as vital sign at each visit. The BW were identified as of potential clinical concern if the vales were increased or decreased from Baseline by >=7%. The Baseline assessments were referred to assessments at Visit 1 (W0). Change from Baseline was measured as the BW at specified visit minus the Baseline value.
8. Number of Participants With Abnormal BW at Any Time During Treatment Period [ Time Frame: Baseline (Visit 1, W0) to W 52 ]
   BW of participants were recorded as vital sign at each visit. The BW were identified as of potential clinical concern if the vales were increased or decreased from Baseline by >=7%. The Baseline assessments were referred to assessments at Visit 1 (W0). Change from Baseline in BW was measured as the BW value at specified visit minus the Baseline BW value. Number of participants with abnormal BW at any time during treatment period were reported.
9. 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 ]
   Non-fasting measures of lipid metabolism including cholesterol (TC), high density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides (TG) were measured at Baseline (W0), W4, W16, W36, W52, Year 2 W24 and Follow-up. The Baseline assessments were referred to assessments at Visit 1 (W0). Change from Baseline was calculated as the value at the indicated visit minus the Baseline value.
10. Number of Participants With Hematological Parameters of Potential Clinical Concern [ Time Frame: Up to 82 weeks ]
    The hematological parameters including eosinophils, lymphocytes, monocytes, platelet count, Segmented Neutrophils, total neutrophils, white blood cell (WBC), red blood cell (RBC) counts, hemoglobin, hematocrit count, mean corpuscle hemoglobin (MCH) and mean corpuscle volume (MCV) were analyzed as safety parameters. The number of participants with values outside the reference range (potential clinical concern ) at any time on treatment (ATOT) and follow-up period were reported. The treatment period was till W104 followed by 6 weeks of follow-up period till W110 of study.
11. Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern [ Time Frame: Up to 82 weeks ]
    The clinical chemistry parameters including alanine amino transferase (ALT), aldolase, aspartate amino transferase (AST), blood urea nitrogen /creatinine (BUN/Creat) ratio, cholesterol (Chol), creatine kinase, creatinine, direct bilirubin, gamma glutamyl transferase (GGT), glucose, high density lipid (HDL), low density lipid (LDL), potassium, troponin 1, and urea were assessed as safety parameters. The number of participants with values outside the reference range (potential clinical concern ) at any time on treatment (ATOT) and follow-up period were reported. The treatment period was till W104 followed by 6 weeks of follow-up period till W110 of study.
12. 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 ]
    The 11-item ADAS-cog was used to assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores ranged from 0 to 70 with higher scores indicating greater dysfunction. Baseline was referred to Visit 1 (W0)assessments. Change from Baseline was calculated as value at scheduled time point minus Baseline value.
13. 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 ]
    The CIBIC+ score used for global functioning assessment. The CIBIC+ assessment comprised of a 7-point rating of severity. It was rated on a scale of 1 to 7 as 1: markedly improved, 2.: moderately improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: moderately worse and 7: markedly worse; The lower score indicated betterment in functioning and higher score means greater dysfunction. The scale was based on interviews with the participant and the caregiver and was completed by an independent rater.
14. 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 ]
    The MMSE consisted of 11 tests of orientation, memory (recent and immediate), concentration, language and praxis. Scores range from 0 to 30, with lower scores indicating greater cognitive impairment. The scale was completed by the investigator, based on the performance of the participant, and took approximately 5 to 10 minutes to administer. Change from parent Baseline in MMSE was analyzed using a mixed model for repeated measures (MMRM). Baseline was referred to Visit 1 (W0)assessments. Change from Baseline was calculated as value at scheduled time point minus Baseline value.
15. 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 ]
    The DAD, assessed the ability of a participant to execute basic and instrumental activities of daily living (ADL) and leisure activities. The scale consists of 40 questions assessing basic and instrumental ADLs. This scale assesses a participant's ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item was scored as yes: 1, no: 0 and N/A: not applicable. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability. The percentage score was calculated as (DAD total score/total number of applicable items) multiplied by 100. The DAD was conducted as an interview with the caregiver and took approximately 20 minutes. Baseline was referred to Visit 1 (W0) assessments. Change from Baseline was calculated as value at scheduled time point minus Baseline value.
16. 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 ]
    The NPI assessed behavioural disturbances comprises 10 dimensions: delusions, hallucinations, dysphoria, apathy, euphoria, disinhibition, aggressiveness and agitation, irritability, anxiety and aberrant motor activity. The participant caregiver asked about behaviour in the participant. If "Yes", the informant then rates both the severity on a 3-point scale, 1: mild to 3: severe (total range: 0-36) and the frequency using a 4-point scale, 1: occasionally to 4: very frequently. The total domain score was frequency × severity. The distress was scored on 5-point scale, 0: no distress to 5 - very severe or extreme. A total NPI score was calculated by adding all domain scores together: NPI total score (from 0-144) and NPI distress score (from 0-60), with higher scores indicating more severe behavioral disturbance. Baseline was referred to Visit 1 (W0) assessments. Change from Baseline was calculated as value at scheduled time point minus Baseline value.
17. Change From Baseline in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Baseline (Vsit 1 W0), W12, W24, W36, W52, W76 and Follow-up (W82) ]
    HbA1c was evaluated as safety parameter in this study. The values of change from Baseline was presented. The Baseline assessments were referred to assessments at Visit 1 (W0). Change from Baseline was measured as the BW at specified visit minus the Baseline value.

Eligibility Criteria

• Ages Eligible for Study: 51 Years to 91 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Locations

United States, California

GSK Investigational Site

Palo Alto, California, United States, 94305

United States, Florida

GSK Investigational Site

Deerfield Beach, Florida, United States, 33064

GSK Investigational Site

Hialeah, Florida, United States, 33016

GSK Investigational Site

Melbourne, Florida, United States, 32901

GSK Investigational Site

Plantation, Florida, United States, 33317

GSK Investigational Site

Tampa, Florida, United States, 33613

United States, Ohio

GSK Investigational Site

Centerville, Ohio, United States, 45459

United States, Oklahoma

GSK Investigational Site

Tulsa, Oklahoma, United States, 74104

United States, Tennessee

GSK Investigational Site

Nashville, Tennessee, United States, 37212

Austria

GSK Investigational Site

Graz-Eggenberg, Austria, A-8020

GSK Investigational Site

Hall in Tirol, Austria, A-6060

Bulgaria

GSK Investigational Site

Plovdiv, Bulgaria, 4000

GSK Investigational Site

Sofia, Bulgaria, 1113

GSK Investigational Site

Sofia, Bulgaria, 1431

GSK Investigational Site

Sofia, Bulgaria, 1527

Chile

GSK Investigational Site

Santiago, Región Metro De Santiago, Chile, 7500710

GSK Investigational Site

Santiago, Región Metro De Santiago, Chile, 7560356

GSK Investigational Site

Viña del Mar, Valparaíso, Chile, 252-0997

China, Guangdong

GSK Investigational Site

Guangzhou, Guangdong, China, 510370

China

GSK Investigational Site

Beijing, China, 100083

GSK Investigational Site

Beijing, China, 100730

GSK Investigational Site

Shanghai, China, 200025

GSK Investigational Site

Shanghai, China, 200030

GSK Investigational Site

Shanghai, China, 200040

GSK Investigational Site

Tianjin, China, 300052

Croatia

GSK Investigational Site

Zagreb, Croatia, 10000

Estonia

GSK Investigational Site

Tallinn, Estonia, 10138

GSK Investigational Site

Tallinn, Estonia, 10614

GSK Investigational Site

Tallinn, Estonia, 10617

GSK Investigational Site

Tartu, Estonia, 51014

Germany

GSK Investigational Site

Ellwangen, Baden-Wuerttemberg, Germany, 73479

GSK Investigational Site

Tuebingen, Baden-Wuerttemberg, Germany, 72076

GSK Investigational Site

Guenzburg, Bayern, Germany, 89312

GSK Investigational Site

Muenchen, Bayern, Germany, 80331

GSK Investigational Site

Nuernberg, Bayern, Germany, 90402

GSK Investigational Site

Unterhaching, Bayern, Germany, 82008

GSK Investigational Site

Bad Homburg, Hessen, Germany, 61348

GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, Germany, 19053

GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, Germany, 19055

GSK Investigational Site

Achim, Niedersachsen, Germany, 28832

GSK Investigational Site

Hannover, Niedersachsen, Germany, 30559

GSK Investigational Site

Baesweiler, Nordrhein-Westfalen, Germany, 52499

GSK Investigational Site

Bochum, Nordrhein-Westfalen, Germany, 44892

GSK Investigational Site

Duisburg, Nordrhein-Westfalen, Germany, 47051

GSK Investigational Site

Juelich, Nordrhein-Westfalen, Germany, 52428

GSK Investigational Site

Koeln, Nordrhein-Westfalen, Germany, 50767

GSK Investigational Site

Dresden, Sachsen, Germany, 01097

GSK Investigational Site

Dresden, Sachsen, Germany, 01307

GSK Investigational Site

Berlin, Germany, 12163

GSK Investigational Site

Berlin, Germany, 12167

GSK Investigational Site

Berlin, Germany, 13507

GSK Investigational Site

Hamburg, Germany, 20249

GSK Investigational Site

Hamburg, Germany, 22083

Greece

GSK Investigational Site

Athens, Greece, 115 21

GSK Investigational Site

Thessaloniki, Greece, 57010

Hungary

GSK Investigational Site

Pécs, Hungary, 7623

GSK Investigational Site

Szeged, Hungary, 6725

Korea, Republic of

GSK Investigational Site

Seongnam-si,, Korea, Republic of, 463-707

GSK Investigational Site

Seoul, Korea, Republic of, 143-729

Mexico

GSK Investigational Site

Saltillo, Coahuila, Mexico, 25000

GSK Investigational Site

Monterrey, Nuevo León, Mexico, 64660

GSK Investigational Site

Mexico, Mexico, 14000

New Zealand

GSK Investigational Site

Auckland, New Zealand, 0622

Peru

GSK Investigational Site

Lima, Peru, Lima 13

Philippines

GSK Investigational Site

Pasig City, Philippines, 1600

Puerto Rico

GSK Investigational Site

San Juan, Puerto Rico, 00918

Russian Federation

GSK Investigational Site

Moscow, Russian Federation, 115522

GSK Investigational Site

Moscow, Russian Federation, 117049

GSK Investigational Site

St.-Petersburg, Russian Federation, 198103

United Kingdom

GSK Investigational Site

West of Scotland Science Park, Glasgow, United Kingdom, G20 0XA

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. 

Study Data/Documents: Study Protocol 

Identifier: AVA102677
For additional information about this study please refer to the GSK Clinical Study Register

Annotated Case Report Form 

Identifier: AVA102677
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: AVA102677
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: AVA102677
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: AVA102677
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: AVA102677
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: AVA102677
For additional information about this study please refer to the GSK Clinical Study Register

Publications:

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.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00550420
• Other Study ID Numbers: AVA102677
• First Posted: October 29, 2007
• Results First Posted: November 8, 2017
• Last Update Posted: November 8, 2017
• Last Verified: August 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:

open-label extension; tolerability; Alzheimer's disease; Rosiglitazone extended-release (XR); safety; cognition; BRL-049653

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Rosiglitazone; Hypoglycemic Agents; Physiological Effects of Drugs