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

9 ottobre 2017 aggiornato da: 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

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

331

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Austria
      • Graz-Eggenberg, Austria, A-8020
        • GSK Investigational Site
      • Hall in Tirol, Austria, A-6060
        • GSK Investigational Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • GSK Investigational Site
      • Sofia, Bulgaria, 1431
        • GSK Investigational Site
      • Sofia, Bulgaria, 1527
        • GSK Investigational Site
      • Sofia, Bulgaria, 1113
        • GSK Investigational Site
  • Chile
    • Región Metro De Santiago
      • Santiago, Región Metro De Santiago, Chile, 7560356
        • GSK Investigational Site
      • Santiago, Región Metro De Santiago, Chile, 7500710
        • GSK Investigational Site
    • Valparaíso
      • Viña del Mar, Valparaíso, Chile, 252-0997
        • GSK Investigational Site
  • Cina
      • Beijing, Cina, 100730
        • GSK Investigational Site
      • Beijing, Cina, 100083
        • GSK Investigational Site
      • Shanghai, Cina, 200025
        • GSK Investigational Site
      • Shanghai, Cina, 200040
        • GSK Investigational Site
      • Shanghai, Cina, 200030
        • GSK Investigational Site
      • Tianjin, Cina, 300052
        • GSK Investigational Site
    • Guangdong
      • Guangzhou, Guangdong, Cina, 510370
        • GSK Investigational Site
  • Corea, Repubblica di
      • Seongnam-si,, Corea, Repubblica di, 463-707
        • GSK Investigational Site
      • Seoul, Corea, Repubblica di, 143-729
        • GSK Investigational Site
  • Croazia
      • Zagreb, Croazia, 10000
        • GSK Investigational Site
  • Estonia
      • Tallinn, Estonia, 10617
        • GSK Investigational Site
      • Tallinn, Estonia, 10138
        • GSK Investigational Site
      • Tallinn, Estonia, 10614
        • GSK Investigational Site
      • Tartu, Estonia, 51014
        • GSK Investigational Site
  • Federazione Russa
      • Moscow, Federazione Russa, 115522
        • GSK Investigational Site
      • Moscow, Federazione Russa, 117049
        • GSK Investigational Site
      • St.-Petersburg, Federazione Russa, 198103
        • GSK Investigational Site
  • Filippine
      • Pasig City, Filippine, 1600
        • GSK Investigational Site
  • Germania
      • Berlin, Germania, 12167
        • GSK Investigational Site
      • Berlin, Germania, 12163
        • GSK Investigational Site
      • Berlin, Germania, 13507
        • GSK Investigational Site
      • Hamburg, Germania, 20249
        • GSK Investigational Site
      • Hamburg, Germania, 22083
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Ellwangen, Baden-Wuerttemberg, Germania, 73479
        • GSK Investigational Site
      • Tuebingen, Baden-Wuerttemberg, Germania, 72076
        • GSK Investigational Site
    • Bayern
      • Guenzburg, Bayern, Germania, 89312
        • GSK Investigational Site
      • Muenchen, Bayern, Germania, 80331
        • GSK Investigational Site
      • Nuernberg, Bayern, Germania, 90402
        • GSK Investigational Site
      • Unterhaching, Bayern, Germania, 82008
        • GSK Investigational Site
    • Hessen
      • Bad Homburg, Hessen, Germania, 61348
        • GSK Investigational Site
    • Mecklenburg-Vorpommern
      • Schwerin, Mecklenburg-Vorpommern, Germania, 19055
        • GSK Investigational Site
      • Schwerin, Mecklenburg-Vorpommern, Germania, 19053
        • GSK Investigational Site
    • Niedersachsen
      • Achim, Niedersachsen, Germania, 28832
        • GSK Investigational Site
      • Hannover, Niedersachsen, Germania, 30559
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Baesweiler, Nordrhein-Westfalen, Germania, 52499
        • GSK Investigational Site
      • Bochum, Nordrhein-Westfalen, Germania, 44892
        • GSK Investigational Site
      • Duisburg, Nordrhein-Westfalen, Germania, 47051
        • GSK Investigational Site
      • Juelich, Nordrhein-Westfalen, Germania, 52428
        • GSK Investigational Site
      • Koeln, Nordrhein-Westfalen, Germania, 50767
        • GSK Investigational Site
    • Sachsen
      • Dresden, Sachsen, Germania, 01307
        • GSK Investigational Site
      • Dresden, Sachsen, Germania, 01097
        • GSK Investigational Site
  • Grecia
      • Athens, Grecia, 115 21
        • GSK Investigational Site
      • Thessaloniki, Grecia, 57010
        • GSK Investigational Site
  • Messico
      • Mexico, Messico, 14000
        • GSK Investigational Site
    • Coahuila
      • Saltillo, Coahuila, Messico, 25000
        • GSK Investigational Site
    • Nuevo León
      • Monterrey, Nuevo León, Messico, 64660
        • GSK Investigational Site
  • Nuova Zelanda
      • Auckland, Nuova Zelanda, 0622
        • GSK Investigational Site
  • Perù
      • Lima, Perù, Lima 13
        • GSK Investigational Site
  • Porto Rico
      • San Juan, Porto Rico, 00918
        • GSK Investigational Site
  • Regno Unito
      • West of Scotland Science Park, Glasgow, Regno Unito, G20 0XA
        • GSK Investigational Site
  • Stati Uniti
    • California
      • Palo Alto, California, Stati Uniti, 94305
        • GSK Investigational Site
    • Florida
      • Deerfield Beach, Florida, Stati Uniti, 33064
        • GSK Investigational Site
      • Hialeah, Florida, Stati Uniti, 33016
        • GSK Investigational Site
      • Melbourne, Florida, Stati Uniti, 32901
        • GSK Investigational Site
      • Plantation, Florida, Stati Uniti, 33317
        • GSK Investigational Site
      • Tampa, Florida, Stati Uniti, 33613
        • GSK Investigational Site
    • Ohio
      • Centerville, Ohio, Stati Uniti, 45459
        • GSK Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, Stati Uniti, 74104
        • GSK Investigational Site
    • Tennessee
      • Nashville, Tennessee, Stati Uniti, 37212
        • GSK Investigational Site
  • Ungheria
      • Pécs, Ungheria, 7623
        • GSK Investigational Site
      • Szeged, Ungheria, 6725
        • GSK Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 51 anni a 91 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Arm 1
Rosiglitazone XR
Droga: Rosiglitazone XR
experimental drug

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Any Adverse Events (AEs) and Severity of AEs
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Serious AEs and Deaths
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

GlaxoSmithKline

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 ottobre 2007

Completamento primario (Effettivo)

12 febbraio 2009

Completamento dello studio (Effettivo)

12 febbraio 2009

Date di iscrizione allo studio

Primo inviato

25 ottobre 2007

Primo inviato che soddisfa i criteri di controllo qualità

25 ottobre 2007

Primo Inserito (Stima)

29 ottobre 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 novembre 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 ottobre 2017

Ultimo verificato

1 agosto 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • AVA102677

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Sì

Descrizione del piano IPD

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

Dati/documenti di studio

  1. Protocollo di studio
    Identificatore informazioni: AVA102677
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  2. Modulo di segnalazione del caso annotato
    Identificatore informazioni: AVA102677
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  3. Piano di analisi statistica
    Identificatore informazioni: AVA102677
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  4. Set di dati del singolo partecipante
    Identificatore informazioni: AVA102677
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  5. Rapporto di studio clinico
    Identificatore informazioni: AVA102677
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  6. Specifica del set di dati
    Identificatore informazioni: AVA102677
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  7. Modulo di consenso informato
    Identificatore informazioni: AVA102677
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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