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Based on preliminary parent study results
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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 either AVA102670 or AVA102672. 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 as adjunctive therapy to their existing dose of acetylcholinesterase inhibitor. 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 either AVA102670 or AVA102672. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosiglitazone XR | Experimental | Investigational drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosiglitazone XR | Drug | Experimental drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Adverse Events (AEs) and Severity of AEs | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The severity of the AE'S was categorized as mild, moderate and severe. Number of participants reporting AEs during the on treatment phase of the study. | Up to 76 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number Participants With Serious Adverse Events (SAEs) and Deaths | A SAE is defined as any untoward medical occurrence that, at any dose results in death, is a life-threatening condition, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or a congenital anomaly or birth defect. Number of participants with SAEs and deaths were reported for treatment duration of the study. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Litchfield Park | Arizona | 85340 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21592048 | Background | Harrington C, Sawchak S, Chiang C, Davies J, Donovan C, Saunders AM, Irizarry M, Jeter B, Zvartau-Hind M, van Dyck CH, Gold M. Rosiglitazone does not improve cognition or global function when used as adjunctive therapy to AChE inhibitors in mild-to-moderate Alzheimer's disease: two phase 3 studies. Curr Alzheimer Res. 2011 Aug;8(5):592-606. doi: 10.2174/156720511796391935. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| AVA102675 | Individual Participant Data Set | View IPD |
Approximately 1800 participants were planned to be enrolled however a total of 1461 participants (after completing parent studies AVA102670/AVA102672) were enrolled and received open-label RSG-XR tablets.
A open-label extension study to evaluate the long-term safety and tolerability of rosiglitazone extended-release (RSG XR) tablets in participants with mild-to moderate Alzheimer's Disease conducted in a total of 29 countries across 267 centers from 08 August 2007 to 30 May 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | RSG XR | Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of Acetylcholinesterase Inhibitor (AChEI) for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received oral 4 milligram (mg) once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Up to 76 Weeks |
| Number of Participants With Adverse Event of Oedema | Oedema 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. The number of participants and their percentage for the adverse event of the various types of oedema were reported. | Up to 76 Weeks |
| Change From Baseline in Vital Sign Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Vital signs SBP and DBP were measured at each visit. All measurements were made on the participant non-dominant arm supported at heart level, using the same cuff size and same equipment. Blood pressure was measured once, after the participant sat quietly for at least 5 minutes. DBP was measured at the disappearance of Korotkoff sounds (Phase V). If the participant was a smoker or used tobacco products, a period of 30 minutes without tobacco was allowed before taking these measurements. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the blood pressure value recorded at specified visit minus the Baseline value. | Up to 70 Weeks (including follow up) |
| Change From Baseline in Vital Sign Heart Rate (HR) | Vital sign HR was measured at each visit. HR was measured once, after the participant sat quietly for at least 5 minutes. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the HR at specified visit minus the Baseline value. | Up to 70 Weeks (including follow up) |
| Change From Baseline in Vital Sign Body Weight (BW) | BW was measured at all visits, without shoes and wearing light clothing. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the body weight at specified visit minus the Baseline value. | Up to 70 Weeks (including follow up) |
| Change From Baseline in Non-fasting Measures of Lipid Metabolism Namely Total Cholesterol (TC), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides | The clinical chemistry data included non-fasting measures of lipid metabolism (TC,HDL,LDL,triglycerides). Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the lipids (TC,HDL,LDL,triglycerides) value recorded at specified visit minus the Baseline value. | Up to 82 Weeks (including follow up) |
| Number of Participants With SBP and DBP Values of Potential Clinical Concern (PCC) | The frequency of participant vital sign sitting blood pressure was obtained to check if the values lie outside of a pre-determined reference range (RR) for SBP 90-140 mmHg, DBP 50-90 mmHg or have a change from Baseline of PCC for SBP increase from Baseline (IFB) >=40, decrease from Baseline (DFB) >= 30 for and for DBP (IFB) >= 30 ,DFB >= 20. The number of participants with values of PCC at any time on treatment (ATOT) and follow up were reported. | Up to 70 Weeks (including follow up) |
| Number of Participants With HR Values of PCC ATOT | HR was measured once, after the participant sat quietly for at least 5 minutes. The frequency of participant vital sign heart rate was obtained to check if the values lie outside of a pre-determined reference range (RR) 50-100 bpm or have a change from Baseline of PCC IFB >=30 and DFB >=30. The number of participants with values of PCC including follow up were reported. | Up to 70 Weeks (including follow up) |
| Number of Participants With BW Values of PCC ATOT | The frequency of participant vital sign weight was obtained to check if the values have CFB of PCC IFB >=7 percent. With the exception of Week 4, when participants were first titrated to the 8mg RSG XR dose, at every time point in the study where weight was measured the percentage of participants experienced an increase in BW of PCC was approximately 2 times greater than the percentage of participants experiencing an decrease in BW of PCC DFB >=7 percent. The number of participants with values of PCC including follow up were reported. | Up to 70 Weeks (including follow up) |
| Number of Participants With Hematology Parameters of PCC ATOT | The hematology data included eosinophils, haematocrit, haemoglobin, lymphocytes, mean corpuscular haemoglobin (MCH), mean corpuscular volume (MCV), monocytes, platelet count, red cell distribution width (RDW), red blood cell (RBC) count, segmented neutrophils (SN), total neutrophils (TN), white blood cell (WBC) count. The number of participants with values of PCC (defined as high and low) ATOT were reported. | Up to Week 82 (including follow up) |
| Number of Participants With Clinical Chemistry Parameters (Including Lipids) of PCC ATOT | The clinical chemistry data included alanine amino transferase (ALT), albumin, aldolase, asparatate amino transferase (AST), BUN/creatinine ratio, carbon dioxide(CO2) content, chloride, cholesterol, creatinine kinase (CK), creatinine, direct bilirubin (DB), gamma glutamyl transferase (GGT), glucose, glycosylated Hemoglobin (HbA1C), HDL, LDL, lactate dehydrogenase (LD), magnesium, potassium, sodium, total bilirubin (TB), triglycerides, troponin I, urea. The number of participants with values of PCC (defined as high and low) ATOT were reported. | Up to Week 82 (including follow up) |
| Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Total Score as a Function of Apolipoprotein E (APOE) ε4 Status. | The 11-item ADAS-Cog 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 for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point. | Baseline (Week 0) and Week 24, 52 |
| Change From Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score as a Function of APOE ε4 Status. | The CDR-SB is a validated clinical assessment of global function in par. with Alzheimer's disease (AD). Impairment was scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or box scores, were added together to give the CDR-Sum of Boxes which ranged from 0 to 18 (severe impairment). Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point. | Baseline (Week 0) and Week 24, 52 |
| Change From Baseline in Mini Mental State Examination (MMSE) Total Score as a Function of APOE ε4 Status. | The MMSE consisted of 11 tests of orientation, memory (recent and immediate), concentration, language and praxis. Scores ranged from 0 to 30, with lower scores indicating greater cognitive impairment. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point. | Baseline (Week 0) and Week 24, 52 |
| Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score as a Function of APOE ε4 Status. | 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) * 100. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point. | Baseline (Week 0) and Week 24, 52 |
| Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score as a Function of APOE ε4 Status. | 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, motor disturbance, appetite, nighttime behavior. A screening question is asked about each sub-domain. If the responses to these questions=participant has problems with a particular sub-domain of behavior, the caregiver asked all the questions about that domain, rating the frequency (1=occasionally to 4=very frequently) on a 4-point scale, their severity (1=Mild to 3=Severe) on a 3-point scale, and the distress on a 5-point scale. Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point. | Baseline (Week 0) and Week 24, 52 |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| GSK Investigational Site | Tucson | Arizona | 85741 | United States |
| GSK Investigational Site | Little Rock | Arkansas | 72205 | United States |
| GSK Investigational Site | Fresno | California | 93720 | United States |
| GSK Investigational Site | Rancho Mirage | California | 92270 | United States |
| GSK Investigational Site | Sacramento | California | 95816 | United States |
| GSK Investigational Site | San Diego | California | 92103 | United States |
| GSK Investigational Site | San Francisco | California | 94109 | United States |
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| GSK Investigational Site | Ocala | Florida | 34471 | United States |
| GSK Investigational Site | St. Petersburg | Florida | 33702 | United States |
| GSK Investigational Site | West Palm Beach | Florida | 33407 | United States |
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| GSK Investigational Site | Rockville | Maryland | 20852 | United States |
| GSK Investigational Site | Springfield | Massachusetts | 01104 | United States |
| GSK Investigational Site | West Yarmouth | Massachusetts | 02673 | United States |
| GSK Investigational Site | Saint Paul | Minnesota | 55101 | United States |
| GSK Investigational Site | Morristown | New Jersey | 07960 | United States |
| GSK Investigational Site | Stratford | New Jersey | 08084 | United States |
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| GSK Investigational Site | Syracuse | New York | 13210 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27607 | United States |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| GSK Investigational Site | Columbus | Ohio | 43210 | United States |
| GSK Investigational Site | Toledo | Ohio | 43623 | United States |
| GSK Investigational Site | Tulsa | Oklahoma | 74104 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15213 | United States |
| GSK Investigational Site | Providence | Rhode Island | 02906 | United States |
| GSK Investigational Site | Austin | Texas | 78757 | United States |
| GSK Investigational Site | South Ogden | Utah | 84403 | United States |
| GSK Investigational Site | Bennington | Vermont | 05201 | United States |
| GSK Investigational Site | Milwaukee | Wisconsin | 53226 | United States |
| GSK Investigational Site | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1192AAW | Argentina |
| GSK Investigational Site | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1419HDN | Argentina |
| GSK Investigational Site | Ciudad de Buenos Aires | Buenos Aires | C1431FWO | Argentina |
| GSK Investigational Site | Córdoba | Córdoba Province | 5000 | Argentina |
| GSK Investigational Site | Córdoba | Córdoba Province | X5004AOA | Argentina |
| GSK Investigational Site | Córdoba | Córdoba Province | x5009bin | Argentina |
| GSK Investigational Site | Godoy Cruz | Mendoza Province | M5504FMI | Argentina |
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| GSK Investigational Site | Hornsby | New South Wales | 2077 | Australia |
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| GSK Investigational Site | Auchenflower | Queensland | 4066 | Australia |
| GSK Investigational Site | Chermside | Queensland | 4032 | Australia |
| GSK Investigational Site | Kippa-Ring | Queensland | 4021 | Australia |
| GSK Investigational Site | Woodville | South Australia | 5011 | Australia |
| GSK Investigational Site | Cheltenham | Victoria | 3192 | Australia |
| GSK Investigational Site | Heidelberg Heights | Victoria | 3084 | Australia |
| GSK Investigational Site | Kew | Victoria | 3101 | Australia |
| GSK Investigational Site | Nedlands | Western Australia | 6009 | Australia |
| GSK Investigational Site | Hall in Tirol | A-6060 | Austria |
| GSK Investigational Site | Vienna | 1010 | Austria |
| GSK Investigational Site | Vienna | 1030 | Austria |
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| GSK Investigational Site | Kortrijk | 8500 | Belgium |
| GSK Investigational Site | Leuven | 3000 | Belgium |
| GSK Investigational Site | Woluwe-Saint-Lambert | 1200 | Belgium |
| GSK Investigational Site | Sofia | 1113 | Bulgaria |
| GSK Investigational Site | Sofia | 1431 | Bulgaria |
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| GSK Investigational Site | Saint John | New Brunswick | E2L 3L6 | Canada |
| GSK Investigational Site | Kentville | Nova Scotia | B4N 4K9 | Canada |
| GSK Investigational Site | Kingston | Ontario | K7L 4X3 | Canada |
| GSK Investigational Site | Kingston | Ontario | K7L 5G2 | Canada |
| GSK Investigational Site | Ottawa | Ontario | K1G 4G3 | Canada |
| GSK Investigational Site | Ottawa | Ontario | K1N 5C8 | Canada |
| GSK Investigational Site | Peterborough | Ontario | K9H 2P4 | Canada |
| GSK Investigational Site | Toronto | Ontario | M3B 2S7 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5T 2S8 | Canada |
| GSK Investigational Site | Toronto | Ontario | M6M 3Z5 | Canada |
| GSK Investigational Site | Whitby | Ontario | L1N 5S9 | Canada |
| GSK Investigational Site | Charlottetown | Prince Edward Island | C1A 5Y8 | Canada |
| GSK Investigational Site | Greenfield Park | Quebec | J4V 2J2 | Canada |
| GSK Investigational Site | Montreal | Quebec | H1T 2M4 | Canada |
| GSK Investigational Site | Montreal | Quebec | H4H 1R3 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1J 3H5 | Canada |
| GSK Investigational Site | Regina | Saskatchewan | S4T 1A5 | Canada |
| GSK Investigational Site | Québec | G1R 3X5 | Canada |
| GSK Investigational Site | Providencia / Santiago | Región Metro de Santiago | 7500710 | Chile |
| GSK Investigational Site | Santiago | Región Metro de Santiago | 7560356 | Chile |
| GSK Investigational Site | Viña del Mar | Valparaiso | 252-0997 | Chile |
| GSK Investigational Site | Olomouc | 775 20 | Czechia |
| GSK Investigational Site | Ostrava | 702 00 | Czechia |
| GSK Investigational Site | Prague | 10000 | Czechia |
| GSK Investigational Site | Prague | 120 00 | Czechia |
| GSK Investigational Site | Prague | 150 18 | Czechia |
| GSK Investigational Site | Prague | 170 00 | Czechia |
| GSK Investigational Site | Prague | 180 00 | Czechia |
| GSK Investigational Site | Trutnov | 541 01 | Czechia |
| GSK Investigational Site | Helsinki | 00120 | Finland |
| GSK Investigational Site | Kuopio | 70211 | Finland |
| GSK Investigational Site | Bourg-en-Bresse | 01012 | France |
| GSK Investigational Site | Caen | 14033 | France |
| GSK Investigational Site | Dijon | 21000 | France |
| GSK Investigational Site | Ivry | 94206 | France |
| GSK Investigational Site | La Seyne-sur-Mer | 83500 | France |
| GSK Investigational Site | Lille | 59000 | France |
| GSK Investigational Site | Limoges | 87042 | France |
| GSK Investigational Site | Luynes | 37230 | France |
| GSK Investigational Site | Lyon | 69006 | France |
| GSK Investigational Site | Marseille | 13008 | France |
| GSK Investigational Site | Marseille | 13009 | France |
| GSK Investigational Site | Metz | 57038 | France |
| GSK Investigational Site | Nantes | 44000 | France |
| GSK Investigational Site | Nantes | 44093 | France |
| GSK Investigational Site | Nantes | 44200 | France |
| GSK Investigational Site | Nantes | 44300 | France |
| GSK Investigational Site | Nice | 06002 | France |
| GSK Investigational Site | Paris | 75013 | France |
| GSK Investigational Site | Pau | 64000 | France |
| GSK Investigational Site | Rodez | 12000 | France |
| GSK Investigational Site | Saint-Etienne | 42100 | France |
| GSK Investigational Site | Saint-Ouen-la-Rouërie | 35460 | France |
| GSK Investigational Site | Sautron | 44880 | France |
| GSK Investigational Site | Tinténiac | 35190 | France |
| GSK Investigational Site | Toulon | 83000 | France |
| GSK Investigational Site | Toulouse | 31300 | France |
| GSK Investigational Site | Tours | 37100 | France |
| GSK Investigational Site | Vichy | 03200 | France |
| GSK Investigational Site | Aalen | Baden-Wurttemberg | 73430 | Germany |
| GSK Investigational Site | Ellwangen | Baden-Wurttemberg | 73479 | Germany |
| GSK Investigational Site | Ludwigsburg | Baden-Wurttemberg | 71634 | Germany |
| GSK Investigational Site | Ostfildern | Baden-Wurttemberg | 73760 | Germany |
| GSK Investigational Site | Stuttgart | Baden-Wurttemberg | 70176 | Germany |
| GSK Investigational Site | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| GSK Investigational Site | Ulm | Baden-Wurttemberg | 89075 | Germany |
| GSK Investigational Site | Alzenau in Unterfranken | Bavaria | 63755 | Germany |
| GSK Investigational Site | Munich | Bavaria | 80331 | Germany |
| GSK Investigational Site | Munich | Bavaria | 80333 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81667 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81675 | Germany |
| GSK Investigational Site | Nuremberg | Bavaria | 90402 | Germany |
| GSK Investigational Site | Regensburg | Bavaria | 93053 | Germany |
| GSK Investigational Site | Unterhaching | Bavaria | 82008 | Germany |
| GSK Investigational Site | Bad Saarow | Brandenburg | 15526 | Germany |
| GSK Investigational Site | Bad Homburg | Hesse | 61348 | Germany |
| GSK Investigational Site | Erbach im Odenwald | Hesse | 64711 | Germany |
| GSK Investigational Site | Achim | Lower Saxony | 28832 | Germany |
| GSK Investigational Site | Bockhorn | Lower Saxony | 26345 | Germany |
| GSK Investigational Site | Ganderkesee | Lower Saxony | 27777 | Germany |
| GSK Investigational Site | Göttingen | Lower Saxony | 37075 | Germany |
| GSK Investigational Site | Hanover | Lower Saxony | 30559 | Germany |
| GSK Investigational Site | Lüneburg | Lower Saxony | 21335 | Germany |
| GSK Investigational Site | Westerstede | Lower Saxony | 26655 | Germany |
| GSK Investigational Site | Schwerin | Mecklenburg-Vorpommern | 19053 | Germany |
| GSK Investigational Site | Bad Honnef | North Rhine-Westphalia | 53604 | Germany |
| GSK Investigational Site | Baesweiler | North Rhine-Westphalia | 52499 | Germany |
| GSK Investigational Site | Bergisch Gladbach | North Rhine-Westphalia | 51465 | Germany |
| GSK Investigational Site | Bochum | North Rhine-Westphalia | 44791 | Germany |
| GSK Investigational Site | Bochum | North Rhine-Westphalia | 44805 | Germany |
| GSK Investigational Site | Bochum | North Rhine-Westphalia | 44869 | Germany |
| GSK Investigational Site | Cologne | North Rhine-Westphalia | 50767 | Germany |
| GSK Investigational Site | Duisburg | North Rhine-Westphalia | 47051 | Germany |
| GSK Investigational Site | Düren | North Rhine-Westphalia | 52349 | Germany |
| GSK Investigational Site | Essen | North Rhine-Westphalia | 45138 | Germany |
| GSK Investigational Site | Hattingen | North Rhine-Westphalia | 45525 | Germany |
| GSK Investigational Site | Jülich | North Rhine-Westphalia | 52428 | Germany |
| GSK Investigational Site | Krefeld | North Rhine-Westphalia | 47800 | Germany |
| GSK Investigational Site | Siegen | North Rhine-Westphalia | 57072 | Germany |
| GSK Investigational Site | Chemnitz | Saxony | 09111 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01097 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01307 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04107 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04157 | Germany |
| GSK Investigational Site | Gera | Thuringia | 07551 | Germany |
| GSK Investigational Site | Jena | Thuringia | 07743 | Germany |
| GSK Investigational Site | Berlin | 12163 | Germany |
| GSK Investigational Site | Berlin | 12167 | Germany |
| GSK Investigational Site | Berlin | 12555 | Germany |
| GSK Investigational Site | Berlin | 13156 | Germany |
| GSK Investigational Site | Berlin | 13357 | Germany |
| GSK Investigational Site | Berlin | 13439 | Germany |
| GSK Investigational Site | Hamburg | 21149 | Germany |
| GSK Investigational Site | Hamburg | 22083 | Germany |
| GSK Investigational Site | Athens | 115 21 | Greece |
| GSK Investigational Site | Athens | 151 23 | Greece |
| GSK Investigational Site | Melíssia | 151 27 | Greece |
| GSK Investigational Site | Thessaloniki | 57010 | Greece |
| GSK Investigational Site | Hong Kong | Hong Kong |
| GSK Investigational Site | Shatin | Hong Kong |
| GSK Investigational Site | Győr | 9024 | Hungary |
| GSK Investigational Site | Szeged | 6725 | Hungary |
| GSK Investigational Site | Hyderabad | 500 034 | India |
| GSK Investigational Site | Nagpur | 440010 | India |
| GSK Investigational Site | New Delhi | 110002 | India |
| GSK Investigational Site | Pune | 411004 | India |
| GSK Investigational Site | Varanasi | 221005 | India |
| GSK Investigational Site | Chieti Scalo | Abruzzo | 66013 | Italy |
| GSK Investigational Site | Naples | Campania | 80131 | Italy |
| GSK Investigational Site | San Felice A Cancello Caserta | Campania | 81027 | Italy |
| GSK Investigational Site | Rome | Lazio | 00148 | Italy |
| GSK Investigational Site | Rome | Lazio | 00163 | Italy |
| GSK Investigational Site | Rome | Lazio | 00186 | Italy |
| GSK Investigational Site | Brescia | Lombardy | 25125 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20122 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20127 | Italy |
| GSK Investigational Site | Pavia | Lombardy | 27100 | Italy |
| GSK Investigational Site | Rho | Lombardy | 20017 | Italy |
| GSK Investigational Site | Torrette (AN) | The Marches | 60020 | Italy |
| GSK Investigational Site | Arezzo | Tuscany | 52100 | Italy |
| GSK Investigational Site | Florence | Tuscany | 50134 | Italy |
| GSK Investigational Site | Pisa | Tuscany | 56126 | Italy |
| GSK Investigational Site | Monterrey | Nuevo León | 64660 | Mexico |
| GSK Investigational Site | Monterrey | Nuevo León | 64710 | Mexico |
| GSK Investigational Site | México | 14000 | Mexico |
| GSK Investigational Site | 's-Hertogenbosch | 5232 JL | Netherlands |
| GSK Investigational Site | Alkmaar | 1815 JD | Netherlands |
| GSK Investigational Site | Blaricum | 1261 AN | Netherlands |
| GSK Investigational Site | Hengelo | 7555 DL | Netherlands |
| GSK Investigational Site | Hilversum | 1213 XZ | Netherlands |
| GSK Investigational Site | The Hague | 2545 CH | Netherlands |
| GSK Investigational Site | Pasig | 1600 | Philippines |
| GSK Investigational Site | Bydgoszcz | 85-096 | Poland |
| GSK Investigational Site | Bydgoszcz | 85-796 | Poland |
| GSK Investigational Site | Katowice | 40-752 | Poland |
| GSK Investigational Site | Mosina | 62-050 | Poland |
| GSK Investigational Site | Poznan | 61-298 | Poland |
| GSK Investigational Site | Sopot | 81-824 | Poland |
| GSK Investigational Site | Warsaw | 02-097 | Poland |
| GSK Investigational Site | Coimbra | 3000-548 | Portugal |
| GSK Investigational Site | Lisbon | 1649-035 | Portugal |
| GSK Investigational Site | Bratislava | 811 01 | Slovakia |
| GSK Investigational Site | Bratislava | 811 07 | Slovakia |
| GSK Investigational Site | Bratislava | 825 56 | Slovakia |
| GSK Investigational Site | Košice | 041 66 | Slovakia |
| GSK Investigational Site | Ljubljana | 1000 | Slovenia |
| GSK Investigational Site | Šempeter v Savinjski Dolini | 5290 | Slovenia |
| GSK Investigational Site | Loeventstein | 7530 | South Africa |
| GSK Investigational Site | Oakdale | 7530 | South Africa |
| GSK Investigational Site | Richards Bay | 3900 | South Africa |
| GSK Investigational Site | Rosebank | 2196 | South Africa |
| GSK Investigational Site | Somerset West | 7130 | South Africa |
| GSK Investigational Site | Waverley, Bloemfontein | 9301 | South Africa |
| GSK Investigational Site | Willows, X14, Pretoria | 0040 | South Africa |
| GSK Investigational Site | Seongnam-si | 463-707 | South Korea |
| GSK Investigational Site | Seoul | 138-736 | South Korea |
| GSK Investigational Site | Seoul | 150-713 | South Korea |
| GSK Investigational Site | Barcelona | 08003 | Spain |
| GSK Investigational Site | Barcelona | 08014 | Spain |
| GSK Investigational Site | Barcelona | 08036 | Spain |
| GSK Investigational Site | Barcelona | 08907 | Spain |
| GSK Investigational Site | Burgos | 09006 | Spain |
| GSK Investigational Site | Castellon | 12004 | Spain |
| GSK Investigational Site | Elche (Alicante) | 03202 | Spain |
| GSK Investigational Site | Girona | 17190 | Spain |
| GSK Investigational Site | Madrid | 28006 | Spain |
| GSK Investigational Site | Murcia | 30120 | Spain |
| GSK Investigational Site | Palma de Mallorca | 07014 | Spain |
| GSK Investigational Site | Tarrasa, Barcelona | 08221 | Spain |
| GSK Investigational Site | Valencia | 46010 | Spain |
| GSK Investigational Site | Jönköping | SE-551 85 | Sweden |
| GSK Investigational Site | Kalix | SE-952 82 | Sweden |
| GSK Investigational Site | Mölndal | SE-431 41 | Sweden |
| GSK Investigational Site | Sundsvall | SE-851 86 | Sweden |
| GSK Investigational Site | Umeå | SE-901 85 | Sweden |
| GSK Investigational Site | Blackpool | Lancashire | FY2 0JH | United Kingdom |
| GSK Investigational Site | Bradford | BD3 0DQ | United Kingdom |
| GSK Investigational Site | Liverpool | L9 7LJ | United Kingdom |
| GSK Investigational Site | West of Scotland Science Park, Glasgow | G20 0XA | United Kingdom |
For additional information about this study please refer to the GSK Clinical Study Register |
| AVA102675 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AVA102675 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AVA102675 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AVA102675 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AVA102675 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AVA102675 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | RSG XR (AVA102675) | Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Any Adverse Events (AEs) and Severity of AEs | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The severity of the AE'S was categorized as mild, moderate and severe. Number of participants reporting AEs during the on treatment phase of the study. | All Subjects (Full population), comprised of all participants who took at least one dose of open-label study medication. | Posted | Count of Participants | Participants | Up to 76 Weeks |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number Participants With Serious Adverse Events (SAEs) and Deaths | A SAE is defined as any untoward medical occurrence that, at any dose results in death, is a life-threatening condition, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or a congenital anomaly or birth defect. Number of participants with SAEs and deaths were reported for treatment duration of the study. | All subject (Full population) | Posted | Count of Participants | Participants | Up to 76 Weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Event of Oedema | Oedema 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. The number of participants and their percentage for the adverse event of the various types of oedema were reported. | All subject (Full population) | Posted | Count of Participants | Participants | Up to 76 Weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Vital Sign Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Vital signs SBP and DBP were measured at each visit. All measurements were made on the participant non-dominant arm supported at heart level, using the same cuff size and same equipment. Blood pressure was measured once, after the participant sat quietly for at least 5 minutes. DBP was measured at the disappearance of Korotkoff sounds (Phase V). If the participant was a smoker or used tobacco products, a period of 30 minutes without tobacco was allowed before taking these measurements. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the blood pressure value recorded at specified visit minus the Baseline value. | All subject (Full population). Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Up to 70 Weeks (including follow up) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Vital Sign Heart Rate (HR) | Vital sign HR was measured at each visit. HR was measured once, after the participant sat quietly for at least 5 minutes. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the HR at specified visit minus the Baseline value. | All subject (Full population). Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Up to 70 Weeks (including follow up) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Vital Sign Body Weight (BW) | BW was measured at all visits, without shoes and wearing light clothing. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the body weight at specified visit minus the Baseline value. | All subject (Full population). Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | kg | Up to 70 Weeks (including follow up) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Non-fasting Measures of Lipid Metabolism Namely Total Cholesterol (TC), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides | The clinical chemistry data included non-fasting measures of lipid metabolism (TC,HDL,LDL,triglycerides). Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the lipids (TC,HDL,LDL,triglycerides) value recorded at specified visit minus the Baseline value. | All subject (Full population). Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | millimole per litre (mmol/l) | Up to 82 Weeks (including follow up) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With SBP and DBP Values of Potential Clinical Concern (PCC) | The frequency of participant vital sign sitting blood pressure was obtained to check if the values lie outside of a pre-determined reference range (RR) for SBP 90-140 mmHg, DBP 50-90 mmHg or have a change from Baseline of PCC for SBP increase from Baseline (IFB) >=40, decrease from Baseline (DFB) >= 30 for and for DBP (IFB) >= 30 ,DFB >= 20. The number of participants with values of PCC at any time on treatment (ATOT) and follow up were reported. | All subject (Full population). Only those participants available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Up to 70 Weeks (including follow up) |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With HR Values of PCC ATOT | HR was measured once, after the participant sat quietly for at least 5 minutes. The frequency of participant vital sign heart rate was obtained to check if the values lie outside of a pre-determined reference range (RR) 50-100 bpm or have a change from Baseline of PCC IFB >=30 and DFB >=30. The number of participants with values of PCC including follow up were reported. | All subject (Full population). Only those participants available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Up to 70 Weeks (including follow up) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With BW Values of PCC ATOT | The frequency of participant vital sign weight was obtained to check if the values have CFB of PCC IFB >=7 percent. With the exception of Week 4, when participants were first titrated to the 8mg RSG XR dose, at every time point in the study where weight was measured the percentage of participants experienced an increase in BW of PCC was approximately 2 times greater than the percentage of participants experiencing an decrease in BW of PCC DFB >=7 percent. The number of participants with values of PCC including follow up were reported. | All subject (Full population). Only those participants available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Up to 70 Weeks (including follow up) |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Hematology Parameters of PCC ATOT | The hematology data included eosinophils, haematocrit, haemoglobin, lymphocytes, mean corpuscular haemoglobin (MCH), mean corpuscular volume (MCV), monocytes, platelet count, red cell distribution width (RDW), red blood cell (RBC) count, segmented neutrophils (SN), total neutrophils (TN), white blood cell (WBC) count. The number of participants with values of PCC (defined as high and low) ATOT were reported. | All subject (Full population). Only those participants available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Up to Week 82 (including follow up) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinical Chemistry Parameters (Including Lipids) of PCC ATOT | The clinical chemistry data included alanine amino transferase (ALT), albumin, aldolase, asparatate amino transferase (AST), BUN/creatinine ratio, carbon dioxide(CO2) content, chloride, cholesterol, creatinine kinase (CK), creatinine, direct bilirubin (DB), gamma glutamyl transferase (GGT), glucose, glycosylated Hemoglobin (HbA1C), HDL, LDL, lactate dehydrogenase (LD), magnesium, potassium, sodium, total bilirubin (TB), triglycerides, troponin I, urea. The number of participants with values of PCC (defined as high and low) ATOT were reported. | All subject population (Full population). Only those participants available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Up to Week 82 (including follow up) |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Total Score as a Function of Apolipoprotein E (APOE) ε4 Status. | The 11-item ADAS-Cog 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 for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point. | All subject (Full population). Only those participants available at the specified time points were analyzed. The analysis was done on the full population and was repeated for APOE subgroups (negative, positive, homozygotes, heterozygotes). | Posted | Mean | Standard Deviation | Scores on scale | Baseline (Week 0) and Week 24, 52 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score as a Function of APOE ε4 Status. | The CDR-SB is a validated clinical assessment of global function in par. with Alzheimer's disease (AD). Impairment was scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or box scores, were added together to give the CDR-Sum of Boxes which ranged from 0 to 18 (severe impairment). Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point. | All subject population. Only those participants available at the specified time points were analyzed. The analysis was done on the full population and was repeated for APOE subgroups (negatives, positives, homozygotes, heterozygotes). | Posted | Mean | Standard Deviation | Scores on scale | Baseline (Week 0) and Week 24, 52 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mini Mental State Examination (MMSE) Total Score as a Function of APOE ε4 Status. | The MMSE consisted of 11 tests of orientation, memory (recent and immediate), concentration, language and praxis. Scores ranged from 0 to 30, with lower scores indicating greater cognitive impairment. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point. | All subject (Full population). Only those participants available at the specified time points were analyzed. The analysis was done on the full population and was repeated for APOE subgroups (negatives, positives, homozygotes, heterozygotes). | Posted | Mean | Standard Deviation | Scores on scale | Baseline (Week 0) and Week 24, 52 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score as a Function of APOE ε4 Status. | 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) * 100. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point. | All subject (Full population). Only those participants available at the specified time points were analyzed.The analysis was done on the full population and was repeated for APOE subgroups (negatives, positives, homozygotes, heterozygotes). | Posted | Mean | Standard Deviation | Scores on scale | Baseline (Week 0) and Week 24, 52 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score as a Function of APOE ε4 Status. | 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, motor disturbance, appetite, nighttime behavior. A screening question is asked about each sub-domain. If the responses to these questions=participant has problems with a particular sub-domain of behavior, the caregiver asked all the questions about that domain, rating the frequency (1=occasionally to 4=very frequently) on a 4-point scale, their severity (1=Mild to 3=Severe) on a 3-point scale, and the distress on a 5-point scale. Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point. | All subject (Full population). Only those participants available at the specified time points were analyzed.The analysis was done on the full population and was repeated for APOE subgroups (negatives, positives, homozygotes, heterozygotes). | Posted | Mean | Standard Deviation | Score on scale | Baseline (Week 0) and Week 24, 52 |
|
Up to 76 Weeks
All subject (Full population) was used for analysis.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RSG XR | Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR. | 20 | 1,461 | 126 | 1,461 | 130 | 1,461 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Pacemaker complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Traumatic fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dementia Alzheimer's type | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Nerve root compression | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Thalamic infarction | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Sinus arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Brain cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Paget's disease of the breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Refractory anaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Behavioural and psychiatric symptoms of dementia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Panic disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Lumbar hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Synovial disorder | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Death | General disorders | MedDRA | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Post thrombotic syndrome | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Blood sodium increased | Investigations | MedDRA | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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