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

2017年10月9日 更新者：GlaxoSmithKline

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.

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

調査の概要

状態

終了しました

条件

介入・治療

研究の種類

介入

入学 (実際)

331

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • California
      • Palo Alto、California、アメリカ、94305
        • GSK Investigational Site
    • Florida
      • Deerfield Beach、Florida、アメリカ、33064
        • GSK Investigational Site
      • Hialeah、Florida、アメリカ、33016
        • GSK Investigational Site
      • Melbourne、Florida、アメリカ、32901
        • GSK Investigational Site
      • Plantation、Florida、アメリカ、33317
        • GSK Investigational Site
      • Tampa、Florida、アメリカ、33613
        • GSK Investigational Site
    • Ohio
      • Centerville、Ohio、アメリカ、45459
        • GSK Investigational Site
    • Oklahoma
      • Tulsa、Oklahoma、アメリカ、74104
        • GSK Investigational Site
    • Tennessee
      • Nashville、Tennessee、アメリカ、37212
        • GSK Investigational Site
  • イギリス
      • West of Scotland Science Park, Glasgow、イギリス、G20 0XA
        • GSK Investigational Site
  • エストニア
      • Tallinn、エストニア、10617
        • GSK Investigational Site
      • Tallinn、エストニア、10138
        • GSK Investigational Site
      • Tallinn、エストニア、10614
        • GSK Investigational Site
      • Tartu、エストニア、51014
        • GSK Investigational Site
  • オーストリア
      • Graz-Eggenberg、オーストリア、A-8020
        • GSK Investigational Site
      • Hall in Tirol、オーストリア、A-6060
        • GSK Investigational Site
  • ギリシャ
      • Athens、ギリシャ、115 21
        • GSK Investigational Site
      • Thessaloniki、ギリシャ、57010
        • GSK Investigational Site
  • クロアチア
      • Zagreb、クロアチア、10000
        • GSK Investigational Site
  • チリ
    • Región Metro De Santiago
      • Santiago、Región Metro De Santiago、チリ、7560356
        • GSK Investigational Site
      • Santiago、Región Metro De Santiago、チリ、7500710
        • GSK Investigational Site
    • Valparaíso
      • Viña del Mar、Valparaíso、チリ、252-0997
        • GSK Investigational Site
  • ドイツ
      • Berlin、ドイツ、12167
        • GSK Investigational Site
      • Berlin、ドイツ、12163
        • GSK Investigational Site
      • Berlin、ドイツ、13507
        • GSK Investigational Site
      • Hamburg、ドイツ、20249
        • GSK Investigational Site
      • Hamburg、ドイツ、22083
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Ellwangen、Baden-Wuerttemberg、ドイツ、73479
        • GSK Investigational Site
      • Tuebingen、Baden-Wuerttemberg、ドイツ、72076
        • GSK Investigational Site
    • Bayern
      • Guenzburg、Bayern、ドイツ、89312
        • GSK Investigational Site
      • Muenchen、Bayern、ドイツ、80331
        • GSK Investigational Site
      • Nuernberg、Bayern、ドイツ、90402
        • GSK Investigational Site
      • Unterhaching、Bayern、ドイツ、82008
        • GSK Investigational Site
    • Hessen
      • Bad Homburg、Hessen、ドイツ、61348
        • GSK Investigational Site
    • Mecklenburg-Vorpommern
      • Schwerin、Mecklenburg-Vorpommern、ドイツ、19055
        • GSK Investigational Site
      • Schwerin、Mecklenburg-Vorpommern、ドイツ、19053
        • GSK Investigational Site
    • Niedersachsen
      • Achim、Niedersachsen、ドイツ、28832
        • GSK Investigational Site
      • Hannover、Niedersachsen、ドイツ、30559
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Baesweiler、Nordrhein-Westfalen、ドイツ、52499
        • GSK Investigational Site
      • Bochum、Nordrhein-Westfalen、ドイツ、44892
        • GSK Investigational Site
      • Duisburg、Nordrhein-Westfalen、ドイツ、47051
        • GSK Investigational Site
      • Juelich、Nordrhein-Westfalen、ドイツ、52428
        • GSK Investigational Site
      • Koeln、Nordrhein-Westfalen、ドイツ、50767
        • GSK Investigational Site
    • Sachsen
      • Dresden、Sachsen、ドイツ、01307
        • GSK Investigational Site
      • Dresden、Sachsen、ドイツ、01097
        • GSK Investigational Site
  • ニュージーランド
      • Auckland、ニュージーランド、0622
        • GSK Investigational Site
  • ハンガリー
      • Pécs、ハンガリー、7623
        • GSK Investigational Site
      • Szeged、ハンガリー、6725
        • GSK Investigational Site
  • フィリピン
      • Pasig City、フィリピン、1600
        • GSK Investigational Site
  • ブルガリア
      • Plovdiv、ブルガリア、4000
        • GSK Investigational Site
      • Sofia、ブルガリア、1431
        • GSK Investigational Site
      • Sofia、ブルガリア、1527
        • GSK Investigational Site
      • Sofia、ブルガリア、1113
        • GSK Investigational Site
  • プエルトリコ
      • San Juan、プエルトリコ、00918
        • GSK Investigational Site
  • ペルー
      • Lima、ペルー、Lima 13
        • GSK Investigational Site
  • メキシコ
      • Mexico、メキシコ、14000
        • GSK Investigational Site
    • Coahuila
      • Saltillo、Coahuila、メキシコ、25000
        • GSK Investigational Site
    • Nuevo León
      • Monterrey、Nuevo León、メキシコ、64660
        • GSK Investigational Site
  • ロシア連邦
      • Moscow、ロシア連邦、115522
        • GSK Investigational Site
      • Moscow、ロシア連邦、117049
        • GSK Investigational Site
      • St.-Petersburg、ロシア連邦、198103
        • GSK Investigational Site
  • 中国
      • Beijing、中国、100730
        • GSK Investigational Site
      • Beijing、中国、100083
        • GSK Investigational Site
      • Shanghai、中国、200025
        • GSK Investigational Site
      • Shanghai、中国、200040
        • GSK Investigational Site
      • Shanghai、中国、200030
        • GSK Investigational Site
      • Tianjin、中国、300052
        • GSK Investigational Site
    • Guangdong
      • Guangzhou、Guangdong、中国、510370
        • GSK Investigational Site
  • 大韓民国
      • Seongnam-si,、大韓民国、463-707
        • GSK Investigational Site
      • Seoul、大韓民国、143-729
        • GSK Investigational Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

51年～91年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：非ランダム化
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Arm 1
Rosiglitazone XR
薬：Rosiglitazone XR
experimental drug

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Number of Participants With Any Adverse Events (AEs) and Severity of AEs
時間枠：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.
Up to Week 82

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of Participants With Serious AEs and Deaths
時間枠：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)
Up to Week 82
Percentage of Participants With AEs of Edema
時間枠：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.
Up to 82 Weeks
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
時間枠：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.
Baseline (Visit 1, W0), W4, W8, W12, W16, W24, W36, W52, W64 and Follow-up (W82)
Change From Baseline in Heart Rate (HR)
時間枠：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.
Baseline (Visit 1, W0), W4, W8, W12, W16, W24, W36, W52, W64 and Follow-up (W82)
Number of Participants With Abnormal SBP and DBP at Any Time During Treatment Period
時間枠：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.
Up to 82 weeks
Number of Participants With Abnormal HR at Any Time During Treatment Period
時間枠：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.
Up to 82 weeks
Change From Baseline in Body Weight (BW)
時間枠：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.
Baseline (Visit 1, W0), W4, W8, W12, W16, W24, W36, W52, W64 and Follow-up (W82)
Number of Participants With Abnormal BW at Any Time During Treatment Period
時間枠：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.
Baseline (Visit 1, W0) to W 52
Change From Baseline in Non-fasting Measures of Lipid Metabolism Including Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein and Triglycerides at Indicated Timepoints.
時間枠：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.
Baseline (Visit 1, W0), W4, W16, W36, W52, W76, and W82
Number of Participants With Hematological Parameters of Potential Clinical Concern
時間枠：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.
Up to 82 weeks
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern
時間枠：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.
Up to 82 weeks
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
時間枠：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.
Baseline (Visit 1, W0), W24 and W52
Mean Clinician Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Score as a Function of APOE 4 Status
時間枠：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.
Baseline (Visit 1, W0), W 24 and W 52
Change From Baseline in Mini Mental State Examination (MMSE) Total Score as a Function of APOE 4 Status at W24 and W52
時間枠：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.
Baseline (Visit 1, W0), W 24 and W52
Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score as a Function of APOEe 4 Status
時間枠：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.
Baseline (Visit 1, W0), W24 and W52
Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score as a Function of APOE 4 Status at W24 and W52
時間枠：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.
Baseline (Visit 1, W0), W24 and W52
Change From Baseline in Glycosylated Haemoglobin (HbA1c)
時間枠：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.
Baseline (Vsit 1 W0), W12, W24, W36, W52, W76 and Follow-up (W82)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

GlaxoSmithKline

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2007年10月1日

一次修了 (実際)

2009年2月12日

研究の完了 (実際)

2009年2月12日

試験登録日

最初に提出

2007年10月25日

QC基準を満たした最初の提出物

2007年10月25日

最初の投稿 (見積もり)

2007年10月29日

学習記録の更新

投稿された最後の更新 (実際)

2017年11月8日

QC基準を満たした最後の更新が送信されました

2017年10月9日

最終確認日

2017年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • AVA102677

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

試験データ・資料

  1. 研究プロトコル
    情報識別子：AVA102677
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  2. 注釈付き症例報告書
    情報識別子：AVA102677
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  3. 統計分析計画
    情報識別子：AVA102677
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  4. 個人参加者データセット
    情報識別子：AVA102677
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  5. 臨床研究報告書
    情報識別子：AVA102677
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  6. データセット仕様
    情報識別子：AVA102677
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  7. インフォームド コンセント フォーム
    情報識別子：AVA102677
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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