A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia (NAVIGATE-AD)
2021年3月22日 更新者：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.
研究概览
研究类型
介入性
注册 (实际的)
316
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Gatineau、加拿大、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.
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Ottawa、加拿大、KIN 5C8
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Verdun、加拿大、H4H 1R3
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Akashi、日本、673-0891
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Hachioji、日本、193-0998
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Ikeda、日本、563-0058
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Kasukabe-shi、日本、344-0036
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Kyoto、日本、606-0851
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Nagoya、日本、451-8511
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Nerima-ku、日本、179-0072
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Osaka、日本、533-0004
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Osaka、日本、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.
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Setagaya-ku、日本、158-8531
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Takamatsu、日本、760-8557
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Tokyo、日本、156-0041
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Wako、日本、351-0111
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Yokosuka-shi、日本、238-0042
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Box Hill、澳大利亚、3128
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Chermside、澳大利亚、4032
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Darlinghurst、澳大利亚、2010
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Erina、澳大利亚、2250
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Glen Iris、澳大利亚、3146
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Heidelberg、澳大利亚、3084
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Herston、澳大利亚、4029
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Nedlands、澳大利亚、6009
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Parkville、澳大利亚、3050
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West Perth、澳大利亚、6005
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California
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Irvine、California、美国、92614
- Irvine Clinical Research Center
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Sacramento、California、美国、95816
- Sutter Medical Group
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San Diego、California、美国、92123
- Sharp Mesa Vista Hospital
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San Diego、California、美国、92103
- Pacific Research Network Inc
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San Francisco、California、美国、94114
- Ray Dolby Brain Health Center/Sutter Health/CPMC
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Santa Ana、California、美国、92705
- Syrentis Clinical Research
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Sebastopol、California、美国、95472
- North Bay Neuroscience Institute
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Connecticut
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Stamford、Connecticut、美国、06905
- New England Institute for Clinical Research
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Delaware
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Wilmington、Delaware、美国、19801
- Christiana Care Health Service
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Florida
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Jacksonville、Florida、美国、32256
- Clinical Neuroscience Solutions Inc
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Melbourne、Florida、美国、32940
- Compass Research
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Miami、Florida、美国、33175
- New Horizon Research Center
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Miami、Florida、美国、33173
- Florida International Research Center
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Miami、Florida、美国、33176
- The Neurology Research Group, LLC
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New Port Richey、Florida、美国、34652
- Suncoast Clinical Research
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Ocala、Florida、美国、34470
- Renstar Medical Research
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Ocoee、Florida、美国、34761
- Sensible Healthcare
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Spring Hill、Florida、美国、34609
- Meridien Research
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Tampa、Florida、美国、33609
- Axiom Research
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Georgia
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Gainesville、Georgia、美国、30501
- United Osteoporosis Center
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Indiana
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Fort Wayne、Indiana、美国、46804
- Fort Wayne Neurological Center
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Indianapolis、Indiana、美国、46202
- Indiana University School of Medicine
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Kansas
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Topeka、Kansas、美国、66606
- Cotton O'Neil Clinic
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Wichita、Kansas、美国、67205
- Heartland Research Associates
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Maryland
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Baltimore、Maryland、美国、21224
- Johns Hopkins University School Of Medicine
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Massachusetts
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Newton、Massachusetts、美国、02459
- Boston Center for Memory
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Missouri
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Bolivar、Missouri、美国、65613
- Missouri Memory Center
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Chesterfield、Missouri、美国、63005
- Clinical Research Professionals
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Creve Coeur、Missouri、美国、63141
- Millenium Psychiatric Associates LLC
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Kansas City、Missouri、美国、64111
- St Lukes Hospital
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Saint Louis、Missouri、美国、63108
- Washington University School of Medicine
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Nevada
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Las Vegas、Nevada、美国、89113
- Las Vegas Medical Research
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New Jersey
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Eatontown、New Jersey、美国、07724
- Memory Enhancement Center of America, Inc.
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Monroe、New Jersey、美国、08831
- Pyramid Clinical Research
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Toms River、New Jersey、美国、08755
- Advanced Memory Research Institute of New Jersey
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Toms River、New Jersey、美国、08755
- Bio Behavioral Health
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New York
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Albany、New York、美国、12206
- Albany Medical College
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Amherst、New York、美国、14226
- Dent Neurological Institute
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Ohio
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Centerville、Ohio、美国、45459
- Valley Medical Primary Care
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Dayton、Ohio、美国、45417
- University of Cincinnati Health Neurology
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Dayton、Ohio、美国、45459
- Neurology Diagnostics, Inc.
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Shaker Heights、Ohio、美国、44122
- Insight Clinical Trials
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Pennsylvania
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Abington、Pennsylvania、美国、19090
- Abington Neurological Associates
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Allentown、Pennsylvania、美国、18104
- Lehigh Center For Clinical Research
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Jenkintown、Pennsylvania、美国、19046
- Clinical Trial Center, LLC, Psychiatry
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South Carolina
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Charleston、South Carolina、美国、29406
- Clinical Trials of South Carolina
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Texas
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Dallas、Texas、美国、75231
- Baylor AT&T Memory Center
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Houston、Texas、美国、77030
- Nantz National Alzheimer Center
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Houston、Texas、美国、77054
- University of Texas Health Services Center - Houston
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
55年 至 85年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Dose 1 LY3202626
3 mg LY3202626 given orally once daily for 52 weeks.
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口服给药
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实验性的：Dose 2 LY3202626
12 mg LY3202626 given orally once daily for 52 weeks.
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口服给药
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实验性的：Placebo
Placebo given orally once daily for 52 weeks.
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口服给药
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change From Baseline in ¹⁸F-AV-1451 Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at 52 Weeks
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Participants With Emergent Magnetic Resonance Imaging (MRI) Findings
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年6月16日
初级完成 (实际的)
2018年7月2日
研究完成 (实际的)
2018年7月2日
研究注册日期
首次提交
2016年6月1日
首先提交符合 QC 标准的
2016年6月1日
首次发布 (估计)
2016年6月6日
研究记录更新
最后更新发布 (实际的)
2021年4月19日
上次提交的符合 QC 标准的更新
2021年3月22日
最后验证
2021年3月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- 16223
- I7X-MC-LLCF (其他标识符：Eli Lilly and Company)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
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 共享时间框架
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 共享访问标准
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD 共享支持信息类型
- 研究协议
- 统计分析计划 (SAP)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.