A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia (NAVIGATE-AD)
2021. március 22. frissítette: 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.
A tanulmány áttekintése
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
316
Fázis
- 2. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Box Hill, Ausztrália, 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, Ausztrália, 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.
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Darlinghurst, Ausztrália, 2010
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Erina, Ausztrália, 2250
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Glen Iris, Ausztrália, 3146
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Heidelberg, Ausztrália, 3084
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Herston, Ausztrália, 4029
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Nedlands, Ausztrália, 6009
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Parkville, Ausztrália, 3050
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West Perth, Ausztrália, 6005
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California
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Irvine, California, Egyesült Államok, 92614
- Irvine Clinical Research Center
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Sacramento, California, Egyesült Államok, 95816
- Sutter Medical Group
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San Diego, California, Egyesült Államok, 92123
- Sharp Mesa Vista Hospital
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San Diego, California, Egyesült Államok, 92103
- Pacific Research Network Inc
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San Francisco, California, Egyesült Államok, 94114
- Ray Dolby Brain Health Center/Sutter Health/CPMC
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Santa Ana, California, Egyesült Államok, 92705
- Syrentis Clinical Research
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Sebastopol, California, Egyesült Államok, 95472
- North Bay Neuroscience Institute
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Connecticut
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Stamford, Connecticut, Egyesült Államok, 06905
- New England Institute for Clinical Research
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Delaware
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Wilmington, Delaware, Egyesült Államok, 19801
- Christiana Care Health Service
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Florida
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Jacksonville, Florida, Egyesült Államok, 32256
- Clinical Neuroscience Solutions Inc
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Melbourne, Florida, Egyesült Államok, 32940
- Compass Research
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Miami, Florida, Egyesült Államok, 33175
- New Horizon Research Center
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Miami, Florida, Egyesült Államok, 33173
- Florida International Research Center
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Miami, Florida, Egyesült Államok, 33176
- The Neurology Research Group, LLC
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New Port Richey, Florida, Egyesült Államok, 34652
- Suncoast Clinical Research
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Ocala, Florida, Egyesült Államok, 34470
- Renstar Medical Research
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Ocoee, Florida, Egyesült Államok, 34761
- Sensible Healthcare
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Spring Hill, Florida, Egyesült Államok, 34609
- Meridien Research
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Tampa, Florida, Egyesült Államok, 33609
- Axiom Research
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Georgia
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Gainesville, Georgia, Egyesült Államok, 30501
- United Osteoporosis Center
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Indiana
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Fort Wayne, Indiana, Egyesült Államok, 46804
- Fort Wayne Neurological Center
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Indianapolis, Indiana, Egyesült Államok, 46202
- Indiana University School of Medicine
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Kansas
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Topeka, Kansas, Egyesült Államok, 66606
- Cotton O'Neil Clinic
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Wichita, Kansas, Egyesült Államok, 67205
- Heartland Research Associates
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Maryland
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Baltimore, Maryland, Egyesült Államok, 21224
- Johns Hopkins University School Of Medicine
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Massachusetts
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Newton, Massachusetts, Egyesült Államok, 02459
- Boston Center for Memory
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Missouri
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Bolivar, Missouri, Egyesült Államok, 65613
- Missouri Memory Center
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Chesterfield, Missouri, Egyesült Államok, 63005
- Clinical Research Professionals
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Creve Coeur, Missouri, Egyesült Államok, 63141
- Millenium Psychiatric Associates LLC
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Kansas City, Missouri, Egyesült Államok, 64111
- St Lukes Hospital
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Saint Louis, Missouri, Egyesült Államok, 63108
- Washington University School of Medicine
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Nevada
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Las Vegas, Nevada, Egyesült Államok, 89113
- Las Vegas Medical Research
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New Jersey
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Eatontown, New Jersey, Egyesült Államok, 07724
- Memory Enhancement Center of America, Inc.
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Monroe, New Jersey, Egyesült Államok, 08831
- Pyramid Clinical Research
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Toms River, New Jersey, Egyesült Államok, 08755
- Advanced Memory Research Institute of New Jersey
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Toms River, New Jersey, Egyesült Államok, 08755
- Bio Behavioral Health
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New York
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Albany, New York, Egyesült Államok, 12206
- Albany Medical College
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Amherst, New York, Egyesült Államok, 14226
- Dent Neurological Institute
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Ohio
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Centerville, Ohio, Egyesült Államok, 45459
- Valley Medical Primary Care
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Dayton, Ohio, Egyesült Államok, 45417
- University of Cincinnati Health Neurology
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Dayton, Ohio, Egyesült Államok, 45459
- Neurology Diagnostics, Inc.
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Shaker Heights, Ohio, Egyesült Államok, 44122
- Insight Clinical Trials
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Pennsylvania
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Abington, Pennsylvania, Egyesült Államok, 19090
- Abington Neurological Associates
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Allentown, Pennsylvania, Egyesült Államok, 18104
- Lehigh Center For Clinical Research
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Jenkintown, Pennsylvania, Egyesült Államok, 19046
- Clinical Trial Center, LLC, Psychiatry
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South Carolina
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Charleston, South Carolina, Egyesült Államok, 29406
- Clinical Trials of South Carolina
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Texas
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Dallas, Texas, Egyesült Államok, 75231
- Baylor AT&T Memory Center
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Houston, Texas, Egyesült Államok, 77030
- Nantz National Alzheimer Center
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Houston, Texas, Egyesült Államok, 77054
- University of Texas Health Services Center - Houston
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Akashi, Japán, 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, Japán, 193-0998
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Ikeda, Japán, 563-0058
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Kasukabe-shi, Japán, 344-0036
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Kyoto, Japán, 606-0851
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Nagoya, Japán, 451-8511
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Nerima-ku, Japán, 179-0072
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Osaka, Japán, 533-0004
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Osaka, Japán, 559-0004
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Setagaya-ku, Japán, 158-8531
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Takamatsu, Japán, 760-8557
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Tokyo, Japán, 156-0041
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Wako, Japán, 351-0111
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Yokosuka-shi, Japán, 238-0042
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Gatineau, Kanada, J8T 8J1
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Ottawa, Kanada, KIN 5C8
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Verdun, Kanada, H4H 1R3
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
55 év (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Leírás
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.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Hármas
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: Dose 1 LY3202626
3 mg LY3202626 given orally once daily for 52 weeks.
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Orálisan beadva
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Kísérleti: Dose 2 LY3202626
12 mg LY3202626 given orally once daily for 52 weeks.
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Orálisan beadva
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Kísérleti: Placebo
Placebo given orally once daily for 52 weeks.
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Orálisan beadva
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Change From Baseline in ¹⁸F-AV-1451 Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at 52 Weeks
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Percentage of Participants With Emergent Magnetic Resonance Imaging (MRI) Findings
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2016. június 16.
Elsődleges befejezés (Tényleges)
2018. július 2.
A tanulmány befejezése (Tényleges)
2018. július 2.
Tanulmányi regisztráció dátumai
Először benyújtva
2016. június 1.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2016. június 1.
Első közzététel (Becslés)
2016. június 6.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2021. április 19.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2021. március 22.
Utolsó ellenőrzés
2021. március 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 16223
- I7X-MC-LLCF (Egyéb azonosító: Eli Lilly and Company)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Igen
IPD terv leírása
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 megosztási időkeret
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-megosztási hozzáférési feltételek
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Az IPD megosztását támogató információ típusa
- Tanulmányi Protokoll
- Statisztikai elemzési terv (SAP)
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .