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A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia (NAVIGATE-AD)

22. März 2021 aktualisiert von: Eli Lilly and Company

Effect of LY3202626 on Alzheimer's Disease Progression as Measured by Cerebral ¹⁸F-AV-1451 Tau-PET in Mild Alzheimer's Disease Dementia

The main purpose of this study is to evaluate the safety and the effect on brain tau of the study drug LY3202626 in participants with mild Alzheimer's disease (AD) dementia.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

316

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Australien
      • Box Hill, Australien, 3128
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Chermside, Australien, 4032
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Darlinghurst, Australien, 2010
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Erina, Australien, 2250
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Glen Iris, Australien, 3146
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Heidelberg, Australien, 3084
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Herston, Australien, 4029
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nedlands, Australien, 6009
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Parkville, Australien, 3050
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • West Perth, Australien, 6005
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Japan
      • Akashi, Japan, 673-0891
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Hachioji, Japan, 193-0998
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ikeda, Japan, 563-0058
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kasukabe-shi, Japan, 344-0036
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kyoto, Japan, 606-0851
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nagoya, Japan, 451-8511
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nerima-ku, Japan, 179-0072
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Osaka, Japan, 533-0004
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Osaka, Japan, 559-0004
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Setagaya-ku, Japan, 158-8531
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Takamatsu, Japan, 760-8557
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tokyo, Japan, 156-0041
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Wako, Japan, 351-0111
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Yokosuka-shi, Japan, 238-0042
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Kanada
      • Gatineau, Kanada, J8T 8J1
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ottawa, Kanada, KIN 5C8
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Verdun, Kanada, H4H 1R3
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Vereinigte Staaten
    • California
      • Irvine, California, Vereinigte Staaten, 92614
        • Irvine Clinical Research Center
      • Sacramento, California, Vereinigte Staaten, 95816
        • Sutter Medical Group
      • San Diego, California, Vereinigte Staaten, 92123
        • Sharp Mesa Vista Hospital
      • San Diego, California, Vereinigte Staaten, 92103
        • Pacific Research Network Inc
      • San Francisco, California, Vereinigte Staaten, 94114
        • Ray Dolby Brain Health Center/Sutter Health/CPMC
      • Santa Ana, California, Vereinigte Staaten, 92705
        • Syrentis Clinical Research
      • Sebastopol, California, Vereinigte Staaten, 95472
        • North Bay Neuroscience Institute
    • Connecticut
      • Stamford, Connecticut, Vereinigte Staaten, 06905
        • New England Institute for Clinical Research
    • Delaware
      • Wilmington, Delaware, Vereinigte Staaten, 19801
        • Christiana Care Health Service
    • Florida
      • Jacksonville, Florida, Vereinigte Staaten, 32256
        • Clinical NeuroScience Solutions Inc
      • Melbourne, Florida, Vereinigte Staaten, 32940
        • Compass Research
      • Miami, Florida, Vereinigte Staaten, 33175
        • New Horizon Research Center
      • Miami, Florida, Vereinigte Staaten, 33173
        • Florida International Research Center
      • Miami, Florida, Vereinigte Staaten, 33176
        • The Neurology Research Group, LLC
      • New Port Richey, Florida, Vereinigte Staaten, 34652
        • Suncoast Clinical Research
      • Ocala, Florida, Vereinigte Staaten, 34470
        • Renstar Medical Research
      • Ocoee, Florida, Vereinigte Staaten, 34761
        • Sensible Healthcare
      • Spring Hill, Florida, Vereinigte Staaten, 34609
        • Meridien Research
      • Tampa, Florida, Vereinigte Staaten, 33609
        • Axiom Research
    • Georgia
      • Gainesville, Georgia, Vereinigte Staaten, 30501
        • United Osteoporosis Center
    • Indiana
      • Fort Wayne, Indiana, Vereinigte Staaten, 46804
        • Fort Wayne Neurological Center
      • Indianapolis, Indiana, Vereinigte Staaten, 46202
        • Indiana University School of Medicine
    • Kansas
      • Topeka, Kansas, Vereinigte Staaten, 66606
        • Cotton O'Neil Clinic
      • Wichita, Kansas, Vereinigte Staaten, 67205
        • Heartland Research Associates
    • Maryland
      • Baltimore, Maryland, Vereinigte Staaten, 21224
        • Johns Hopkins University School of Medicine
    • Massachusetts
      • Newton, Massachusetts, Vereinigte Staaten, 02459
        • Boston Center for Memory
    • Missouri
      • Bolivar, Missouri, Vereinigte Staaten, 65613
        • Missouri Memory Center
      • Chesterfield, Missouri, Vereinigte Staaten, 63005
        • Clinical Research Professionals
      • Creve Coeur, Missouri, Vereinigte Staaten, 63141
        • Millenium Psychiatric Associates LLC
      • Kansas City, Missouri, Vereinigte Staaten, 64111
        • St Lukes Hospital
      • Saint Louis, Missouri, Vereinigte Staaten, 63108
        • Washington University School of Medicine
    • Nevada
      • Las Vegas, Nevada, Vereinigte Staaten, 89113
        • Las Vegas Medical Research
    • New Jersey
      • Eatontown, New Jersey, Vereinigte Staaten, 07724
        • Memory Enhancement Center of America, Inc.
      • Monroe, New Jersey, Vereinigte Staaten, 08831
        • Pyramid Clinical Research
      • Toms River, New Jersey, Vereinigte Staaten, 08755
        • Advanced Memory Research Institute of New Jersey
      • Toms River, New Jersey, Vereinigte Staaten, 08755
        • Bio Behavioral Health
    • New York
      • Albany, New York, Vereinigte Staaten, 12206
        • Albany Medical College
      • Amherst, New York, Vereinigte Staaten, 14226
        • Dent Neurological Institute
    • Ohio
      • Centerville, Ohio, Vereinigte Staaten, 45459
        • Valley Medical Primary Care
      • Dayton, Ohio, Vereinigte Staaten, 45417
        • University of Cincinnati Health Neurology
      • Dayton, Ohio, Vereinigte Staaten, 45459
        • Neurology Diagnostics, Inc.
      • Shaker Heights, Ohio, Vereinigte Staaten, 44122
        • Insight Clinical Trials
    • Pennsylvania
      • Abington, Pennsylvania, Vereinigte Staaten, 19090
        • Abington Neurological Associates
      • Allentown, Pennsylvania, Vereinigte Staaten, 18104
        • Lehigh Center for Clinical Research
      • Jenkintown, Pennsylvania, Vereinigte Staaten, 19046
        • Clinical Trial Center, LLC, Psychiatry
    • South Carolina
      • Charleston, South Carolina, Vereinigte Staaten, 29406
        • Clinical Trials of South Carolina
    • Texas
      • Dallas, Texas, Vereinigte Staaten, 75231
        • Baylor AT&T Memory Center
      • Houston, Texas, Vereinigte Staaten, 77030
        • Nantz National Alzheimer Center
      • Houston, Texas, Vereinigte Staaten, 77054
        • University of Texas Health Services Center - Houston

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

55 Jahre bis 85 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Present with mild AD dementia based on the National Institute on Aging (NIA) and the Alzheimer's Association (AA) disease diagnostic criteria as determined by a qualified clinician approved by the Sponsor or designee.
  • Mini-Mental State Examination score of 20 to 26 inclusive at screening visit.
  • Has a florbetapir PET scan consistent with the presence of amyloid pathology at screening.

Exclusion Criteria:

  • Significant neurological disease affecting the central nervous system (CNS), other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures (except febrile childhood seizures).
  • Ocular pathology that significantly limits ability to reliably evaluate vision or the retina.
  • Use of strong inducers of cytochrome P450 3A (CYP3A).
  • Sensitivity to florbetapir or ¹⁸F-AV-1451.
  • Contraindication to MRI or PET or poor venous access for blood draws.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Dose 1 LY3202626
3 mg LY3202626 given orally once daily for 52 weeks.
Arzneimittel: LY3202626
Oral verabreicht
Experimental: Dose 2 LY3202626
12 mg LY3202626 given orally once daily for 52 weeks.
Arzneimittel: LY3202626
Oral verabreicht
Experimental: Placebo
Placebo given orally once daily for 52 weeks.
Arzneimittel: Placebo
Oral verabreicht

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in ¹⁸F-AV-1451 Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at 52 Weeks
Zeitfenster: Baseline, Week 52
The 18F-AV-1451 PET tracer assesses change from baseline in the pharmacodynamic effect of 3 mg and 12 mg doses of LY3202626 in participants with mild Alzheimer's disease (AD), compared with placebo at Week 52.The SUVr of ¹⁸F-AV-1451 was modeled using analysis of covariance (ANCOVA) to include the fixed, categorical effects of treatment dose, and the continuous, fixed covariate of baseline Tau PET SUVr and age at baseline.
Baseline, Week 52

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With Emergent Magnetic Resonance Imaging (MRI) Findings
Zeitfenster: Week 52
Percentage of participants with treatment-emergent MRI findings at Week 52 are summarized here. The mixed-effect model for repeated measures (MMRM) analysis was adjusted for fixed effects of treatment, visit (categorical covariate), treatment-by-visit interaction, baseline age, baseline score (continuous covariate) and baseline-by-visit interaction.
Week 52
Percentage of Participants With Amyloid-Related Imaging Abnormalities (ARIA)
Zeitfenster: Week 52
Percentage of participants with presence of amyloid-related imaging abnormalities-edema (ARIA-E, also known as vasogenic edema) and percentage of an increase in amyloid-related imaging abnormalities-hemorrhage (ARIA-H, also known as also known as microhemorrhage) at Week 52 are summarized here. The mixed-effect model for repeated measures (MMRM) analysis was adjusted for fixed effects of treatment, visit (categorical covariate), treatment-by-visit interaction, baseline age, baseline score (continuous covariate) and baseline-by-visit interaction.
Week 52
Percentage of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Scores
Zeitfenster: Baseline through Week 52
The Columbia-Suicide Severity Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation is defined as a "yes" answer to any 1 of 5 suicidal ideation questions, which includes a wish to be dead and 4 different categories of active suicidal ideation. Suicidal behavior is defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation and behavior are defined as treatment-emergent (TE) if not present during the period up through randomization. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.
Baseline through Week 52
Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve at Steady State (AUC [T,SS]) of LY3202626
Zeitfenster: Week 2, 4, and 12: Predose and Postdose prior to departing; Week 8 and 16: Postdose after arriving and prior to departing; Week 24: Postdose after cognitive testing
PK: AUC [T,SS] of LY3202626
Week 2, 4, and 12: Predose and Postdose prior to departing; Week 8 and 16: Postdose after arriving and prior to departing; Week 24: Postdose after cognitive testing
Change From Baseline in Plasma Amyloid Beta Aβ₁-₄₀, ₁-₄₂, and 1-x Concentration
Zeitfenster: Baseline, Week 52
A mixed model repeated measures (MMRM) analysis will be used to evaluate the change from baseline to Week 52 in plasma Aβ₁-₄₀, Aβ₁-₄₂, and Aβ 1-x. The model for the fixed effects will include terms for the following independent effects: log transformed baseline plasma Aβ, treatment, visit, treatment-by-visit interaction.
Baseline, Week 52
Change From Baseline on the 13-item Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog₁₃)
Zeitfenster: Baseline, Week 52
The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS that was used as the primary efficacy measure consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS--Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity. A mixed model repeated measures (MMRM) was used in analysis. The model included fixed, categorical effects of treatment, visit and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline, baseline-by-visit, and age at baseline.
Baseline, Week 52
Change From Baseline on the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Inventory (ADCS-iADL)
Zeitfenster: Baseline, Week 52
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities (instrumental activity items 7-23) of daily living by participants. The range for the ADCS-iADL is 0-56 with higher scores reflecting better performance. ADCS-iADL was analyzed using mixed-model repeated measures (MMRM), Least Square (LS) Mean was controlled for treatment, visit, treatment-by-visit interaction, baseline age, baseline score and baseline-by-visit interaction.
Baseline, Week 52
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)
Zeitfenster: Baseline, Week 52
The iADRS comprises scores form the ADAS-Cog and the ADCS-iADL. The iADRS is calculated as a linear combination of the total scores of the ADAS-Cog13 9score range 0 to 85 with higher scores reflecting worse performance and the ADCS-iADL (score range 0-56 with higher scores reflecting better performance). The iADRS score ranges from 0 to 141 with lower scores indicating worse performance. iADRS was analyzed using mixed-model repeated measures (MMRM); Least Square (LS) Mean was controlled for treatment, visit, treatment-by-visit interaction, baseline age, baseline score and baseline-by-visit interaction.
Baseline, Week 52

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Eli Lilly and Company

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

16. Juni 2016

Primärer Abschluss (Tatsächlich)

2. Juli 2018

Studienabschluss (Tatsächlich)

2. Juli 2018

Studienanmeldedaten

Zuerst eingereicht

1. Juni 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Juni 2016

Zuerst gepostet (Schätzen)

6. Juni 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

19. April 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. März 2021

Zuletzt verifiziert

1. März 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 16223
  • I7X-MC-LLCF (Andere Kennung: Eli Lilly and Company)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Ja

Beschreibung des IPD-Plans

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD-Sharing-Zeitrahmen

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD-Sharing-Zugriffskriterien

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Art der unterstützenden IPD-Freigabeinformationen

  • Studienprotokoll
  • Statistischer Analyseplan (SAP)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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