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

22 marca 2021 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

316

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Australia
      • Box Hill, Australia, 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, Australia, 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, Australia, 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, Australia, 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, Australia, 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, Australia, 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, Australia, 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, Australia, 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, Australia, 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, Australia, 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.
  • Japonia
      • Akashi, Japonia, 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, Japonia, 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, Japonia, 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, Japonia, 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, Japonia, 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, Japonia, 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, Japonia, 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, Japonia, 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, Japonia, 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, Japonia, 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, Japonia, 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, Japonia, 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, Japonia, 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, Japonia, 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.
  • Stany Zjednoczone
    • California
      • Irvine, California, Stany Zjednoczone, 92614
        • Irvine Clinical Research Center
      • Sacramento, California, Stany Zjednoczone, 95816
        • Sutter Medical Group
      • San Diego, California, Stany Zjednoczone, 92123
        • Sharp Mesa Vista Hospital
      • San Diego, California, Stany Zjednoczone, 92103
        • Pacific Research Network Inc
      • San Francisco, California, Stany Zjednoczone, 94114
        • Ray Dolby Brain Health Center/Sutter Health/CPMC
      • Santa Ana, California, Stany Zjednoczone, 92705
        • Syrentis Clinical Research
      • Sebastopol, California, Stany Zjednoczone, 95472
        • North Bay Neuroscience Institute
    • Connecticut
      • Stamford, Connecticut, Stany Zjednoczone, 06905
        • New England Institute for Clinical Research
    • Delaware
      • Wilmington, Delaware, Stany Zjednoczone, 19801
        • Christiana Care Health Service
    • Florida
      • Jacksonville, Florida, Stany Zjednoczone, 32256
        • Clinical NeuroScience Solutions Inc
      • Melbourne, Florida, Stany Zjednoczone, 32940
        • Compass Research
      • Miami, Florida, Stany Zjednoczone, 33175
        • New Horizon Research Center
      • Miami, Florida, Stany Zjednoczone, 33173
        • Florida International Research Center
      • Miami, Florida, Stany Zjednoczone, 33176
        • The Neurology Research Group, LLC
      • New Port Richey, Florida, Stany Zjednoczone, 34652
        • Suncoast Clinical Research
      • Ocala, Florida, Stany Zjednoczone, 34470
        • Renstar Medical Research
      • Ocoee, Florida, Stany Zjednoczone, 34761
        • Sensible Healthcare
      • Spring Hill, Florida, Stany Zjednoczone, 34609
        • Meridien Research
      • Tampa, Florida, Stany Zjednoczone, 33609
        • Axiom Research
    • Georgia
      • Gainesville, Georgia, Stany Zjednoczone, 30501
        • United Osteoporosis Center
    • Indiana
      • Fort Wayne, Indiana, Stany Zjednoczone, 46804
        • Fort Wayne Neurological Center
      • Indianapolis, Indiana, Stany Zjednoczone, 46202
        • Indiana University School of Medicine
    • Kansas
      • Topeka, Kansas, Stany Zjednoczone, 66606
        • Cotton O'Neil Clinic
      • Wichita, Kansas, Stany Zjednoczone, 67205
        • Heartland Research Associates
    • Maryland
      • Baltimore, Maryland, Stany Zjednoczone, 21224
        • Johns Hopkins University School of Medicine
    • Massachusetts
      • Newton, Massachusetts, Stany Zjednoczone, 02459
        • Boston Center for Memory
    • Missouri
      • Bolivar, Missouri, Stany Zjednoczone, 65613
        • Missouri Memory Center
      • Chesterfield, Missouri, Stany Zjednoczone, 63005
        • Clinical Research Professionals
      • Creve Coeur, Missouri, Stany Zjednoczone, 63141
        • Millenium Psychiatric Associates LLC
      • Kansas City, Missouri, Stany Zjednoczone, 64111
        • St Lukes Hospital
      • Saint Louis, Missouri, Stany Zjednoczone, 63108
        • Washington University School of Medicine
    • Nevada
      • Las Vegas, Nevada, Stany Zjednoczone, 89113
        • Las Vegas Medical Research
    • New Jersey
      • Eatontown, New Jersey, Stany Zjednoczone, 07724
        • Memory Enhancement Center of America, Inc.
      • Monroe, New Jersey, Stany Zjednoczone, 08831
        • Pyramid Clinical Research
      • Toms River, New Jersey, Stany Zjednoczone, 08755
        • Advanced Memory Research Institute of New Jersey
      • Toms River, New Jersey, Stany Zjednoczone, 08755
        • Bio Behavioral Health
    • New York
      • Albany, New York, Stany Zjednoczone, 12206
        • Albany Medical College
      • Amherst, New York, Stany Zjednoczone, 14226
        • Dent Neurological Institute
    • Ohio
      • Centerville, Ohio, Stany Zjednoczone, 45459
        • Valley Medical Primary Care
      • Dayton, Ohio, Stany Zjednoczone, 45417
        • University of Cincinnati Health Neurology
      • Dayton, Ohio, Stany Zjednoczone, 45459
        • Neurology Diagnostics, Inc.
      • Shaker Heights, Ohio, Stany Zjednoczone, 44122
        • Insight Clinical Trials
    • Pennsylvania
      • Abington, Pennsylvania, Stany Zjednoczone, 19090
        • Abington Neurological Associates
      • Allentown, Pennsylvania, Stany Zjednoczone, 18104
        • Lehigh Center for Clinical Research
      • Jenkintown, Pennsylvania, Stany Zjednoczone, 19046
        • Clinical Trial Center, LLC, Psychiatry
    • South Carolina
      • Charleston, South Carolina, Stany Zjednoczone, 29406
        • Clinical Trials of South Carolina
    • Texas
      • Dallas, Texas, Stany Zjednoczone, 75231
        • Baylor AT&T Memory Center
      • Houston, Texas, Stany Zjednoczone, 77030
        • Nantz National Alzheimer Center
      • Houston, Texas, Stany Zjednoczone, 77054
        • University of Texas Health Services Center - Houston

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

55 lat do 85 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Dose 1 LY3202626
3 mg LY3202626 given orally once daily for 52 weeks.
Lek: LY3202626
Podawany doustnie
Eksperymentalny: Dose 2 LY3202626
12 mg LY3202626 given orally once daily for 52 weeks.
Lek: LY3202626
Podawany doustnie
Eksperymentalny: Placebo
Placebo given orally once daily for 52 weeks.
Lek: Placebo
Podawany doustnie

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in ¹⁸F-AV-1451 Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at 52 Weeks
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Participants With Emergent Magnetic Resonance Imaging (MRI) Findings
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Eli Lilly and Company

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

16 czerwca 2016

Zakończenie podstawowe (Rzeczywisty)

2 lipca 2018

Ukończenie studiów (Rzeczywisty)

2 lipca 2018

Daty rejestracji na studia

Pierwszy przesłany

1 czerwca 2016

Pierwszy przesłany, który spełnia kryteria kontroli jakości

1 czerwca 2016

Pierwszy wysłany (Oszacować)

6 czerwca 2016

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

19 kwietnia 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 marca 2021

Ostatnia weryfikacja

1 marca 2021

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 16223
  • I7X-MC-LLCF (Inny identyfikator: Eli Lilly and Company)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAk

Opis planu IPD

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.

Ramy czasowe udostępniania IPD

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.

Kryteria dostępu do udostępniania IPD

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

Typ informacji pomocniczych dotyczących udostępniania IPD

  • Protokół badania
  • Plan analizy statystycznej (SAP)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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