A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia (NAVIGATE-AD)
22 de março de 2021 atualizado por: 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.
Visão geral do estudo
Status
Rescindido
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
316
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Box Hill, Austrália, 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.
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Chermside, Austrália, 4032
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Darlinghurst, Austrália, 2010
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Erina, Austrália, 2250
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Glen Iris, Austrália, 3146
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Heidelberg, Austrália, 3084
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Herston, Austrália, 4029
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Nedlands, Austrália, 6009
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Parkville, Austrália, 3050
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West Perth, Austrália, 6005
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Gatineau, Canadá, J8T 8J1
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Ottawa, Canadá, KIN 5C8
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Verdun, Canadá, H4H 1R3
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California
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Irvine, California, Estados Unidos, 92614
- Irvine Clinical Research Center
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Sacramento, California, Estados Unidos, 95816
- Sutter Medical Group
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San Diego, California, Estados Unidos, 92123
- Sharp Mesa Vista Hospital
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San Diego, California, Estados Unidos, 92103
- Pacific Research Network Inc
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San Francisco, California, Estados Unidos, 94114
- Ray Dolby Brain Health Center/Sutter Health/CPMC
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Santa Ana, California, Estados Unidos, 92705
- Syrentis Clinical Research
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Sebastopol, California, Estados Unidos, 95472
- North Bay Neuroscience Institute
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Connecticut
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Stamford, Connecticut, Estados Unidos, 06905
- New England Institute for Clinical Research
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Delaware
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Wilmington, Delaware, Estados Unidos, 19801
- Christiana Care Health Service
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Florida
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Jacksonville, Florida, Estados Unidos, 32256
- Clinical Neuroscience Solutions Inc
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Melbourne, Florida, Estados Unidos, 32940
- Compass Research
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Miami, Florida, Estados Unidos, 33175
- New Horizon Research Center
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Miami, Florida, Estados Unidos, 33173
- Florida International Research Center
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Miami, Florida, Estados Unidos, 33176
- The Neurology Research Group, LLC
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New Port Richey, Florida, Estados Unidos, 34652
- Suncoast Clinical Research
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Ocala, Florida, Estados Unidos, 34470
- Renstar Medical Research
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Ocoee, Florida, Estados Unidos, 34761
- Sensible Healthcare
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Spring Hill, Florida, Estados Unidos, 34609
- Meridien Research
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Tampa, Florida, Estados Unidos, 33609
- Axiom Research
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Georgia
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Gainesville, Georgia, Estados Unidos, 30501
- United Osteoporosis Center
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Indiana
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Fort Wayne, Indiana, Estados Unidos, 46804
- Fort Wayne Neurological Center
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University School of Medicine
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Kansas
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Topeka, Kansas, Estados Unidos, 66606
- Cotton O'Neil Clinic
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Wichita, Kansas, Estados Unidos, 67205
- Heartland Research Associates
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Maryland
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Baltimore, Maryland, Estados Unidos, 21224
- Johns Hopkins University School of Medicine
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Massachusetts
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Newton, Massachusetts, Estados Unidos, 02459
- Boston Center for Memory
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Missouri
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Bolivar, Missouri, Estados Unidos, 65613
- Missouri Memory Center
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Chesterfield, Missouri, Estados Unidos, 63005
- Clinical Research Professionals
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Creve Coeur, Missouri, Estados Unidos, 63141
- Millenium Psychiatric Associates LLC
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Kansas City, Missouri, Estados Unidos, 64111
- St Lukes Hospital
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Saint Louis, Missouri, Estados Unidos, 63108
- Washington University School of Medicine
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89113
- Las Vegas Medical Research
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New Jersey
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Eatontown, New Jersey, Estados Unidos, 07724
- Memory Enhancement Center of America, Inc.
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Monroe, New Jersey, Estados Unidos, 08831
- Pyramid Clinical Research
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Toms River, New Jersey, Estados Unidos, 08755
- Advanced Memory Research Institute of New Jersey
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Toms River, New Jersey, Estados Unidos, 08755
- Bio Behavioral Health
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New York
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Albany, New York, Estados Unidos, 12206
- Albany Medical College
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Amherst, New York, Estados Unidos, 14226
- Dent Neurological Institute
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Ohio
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Centerville, Ohio, Estados Unidos, 45459
- Valley Medical Primary Care
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Dayton, Ohio, Estados Unidos, 45417
- University of Cincinnati Health Neurology
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Dayton, Ohio, Estados Unidos, 45459
- Neurology Diagnostics, Inc.
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Shaker Heights, Ohio, Estados Unidos, 44122
- Insight Clinical Trials
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Pennsylvania
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Abington, Pennsylvania, Estados Unidos, 19090
- Abington Neurological Associates
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Allentown, Pennsylvania, Estados Unidos, 18104
- Lehigh Center For Clinical Research
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Jenkintown, Pennsylvania, Estados Unidos, 19046
- Clinical Trial Center, LLC, Psychiatry
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29406
- Clinical Trials of South Carolina
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Texas
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Dallas, Texas, Estados Unidos, 75231
- Baylor AT&T Memory Center
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Houston, Texas, Estados Unidos, 77030
- Nantz National Alzheimer Center
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Houston, Texas, Estados Unidos, 77054
- University of Texas Health Services Center - Houston
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Akashi, Japão, 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.
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Hachioji, Japão, 193-0998
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Ikeda, Japão, 563-0058
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Kasukabe-shi, Japão, 344-0036
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Kyoto, Japão, 606-0851
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Nagoya, Japão, 451-8511
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Nerima-ku, Japão, 179-0072
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Osaka, Japão, 533-0004
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Osaka, Japão, 559-0004
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Setagaya-ku, Japão, 158-8531
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Takamatsu, Japão, 760-8557
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Tokyo, Japão, 156-0041
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Wako, Japão, 351-0111
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Yokosuka-shi, Japão, 238-0042
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
55 anos a 85 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Dose 1 LY3202626
3 mg LY3202626 given orally once daily for 52 weeks.
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Administrado por via oral
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Experimental: Dose 2 LY3202626
12 mg LY3202626 given orally once daily for 52 weeks.
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Administrado por via oral
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Experimental: Placebo
Placebo given orally once daily for 52 weeks.
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Administrado por via oral
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Change From Baseline in ¹⁸F-AV-1451 Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at 52 Weeks
Prazo: Baseline, Week 52
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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.
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Baseline, Week 52
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Percentage of Participants With Emergent Magnetic Resonance Imaging (MRI) Findings
Prazo: Week 52
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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.
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Week 52
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Percentage of Participants With Amyloid-Related Imaging Abnormalities (ARIA)
Prazo: Week 52
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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.
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Week 52
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Percentage of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Scores
Prazo: Baseline through Week 52
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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.
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Baseline through Week 52
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Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve at Steady State (AUC [T,SS]) of LY3202626
Prazo: 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
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PK: AUC [T,SS] of LY3202626
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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
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Change From Baseline in Plasma Amyloid Beta Aβ₁-₄₀, ₁-₄₂, and 1-x Concentration
Prazo: Baseline, Week 52
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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.
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Baseline, Week 52
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Change From Baseline on the 13-item Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog₁₃)
Prazo: Baseline, Week 52
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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.
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Baseline, Week 52
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Change From Baseline on the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Inventory (ADCS-iADL)
Prazo: Baseline, Week 52
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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.
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Baseline, Week 52
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Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)
Prazo: Baseline, Week 52
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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.
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Baseline, Week 52
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
16 de junho de 2016
Conclusão Primária (Real)
2 de julho de 2018
Conclusão do estudo (Real)
2 de julho de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
1 de junho de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de junho de 2016
Primeira postagem (Estimativa)
6 de junho de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
19 de abril de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de março de 2021
Última verificação
1 de março de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 16223
- I7X-MC-LLCF (Outro identificador: Eli Lilly and Company)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Sim
Descrição do plano 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.
Prazo de Compartilhamento de 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.
Critérios de acesso de compartilhamento IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Tipo de informação de suporte de compartilhamento de IPD
- Protocolo de estudo
- Plano de Análise Estatística (SAP)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .