A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia (NAVIGATE-AD)
22 maart 2021 bijgewerkt door: 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.
Studie Overzicht
Toestand
Beëindigd
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
316
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Box Hill, Australië, 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, Australië, 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, Australië, 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.
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Erina, Australië, 2250
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Glen Iris, Australië, 3146
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Heidelberg, Australië, 3084
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Herston, Australië, 4029
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Nedlands, Australië, 6009
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Parkville, Australië, 3050
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West Perth, Australië, 6005
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Gatineau, Canada, J8T 8J1
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Ottawa, Canada, KIN 5C8
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Verdun, Canada, H4H 1R3
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Akashi, Japan, 673-0891
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Hachioji, Japan, 193-0998
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Ikeda, Japan, 563-0058
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Kasukabe-shi, Japan, 344-0036
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Kyoto, Japan, 606-0851
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Nagoya, Japan, 451-8511
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Nerima-ku, Japan, 179-0072
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Osaka, Japan, 533-0004
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Osaka, Japan, 559-0004
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Setagaya-ku, Japan, 158-8531
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Takamatsu, Japan, 760-8557
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Tokyo, Japan, 156-0041
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wako, Japan, 351-0111
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Yokosuka-shi, Japan, 238-0042
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California
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Irvine, California, Verenigde Staten, 92614
- Irvine Clinical Research Center
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Sacramento, California, Verenigde Staten, 95816
- Sutter Medical Group
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San Diego, California, Verenigde Staten, 92123
- Sharp Mesa Vista Hospital
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San Diego, California, Verenigde Staten, 92103
- Pacific Research Network Inc
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San Francisco, California, Verenigde Staten, 94114
- Ray Dolby Brain Health Center/Sutter Health/CPMC
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Santa Ana, California, Verenigde Staten, 92705
- Syrentis Clinical Research
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Sebastopol, California, Verenigde Staten, 95472
- North Bay Neuroscience Institute
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Connecticut
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Stamford, Connecticut, Verenigde Staten, 06905
- New England Institute for Clinical Research
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Delaware
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Wilmington, Delaware, Verenigde Staten, 19801
- Christiana Care Health Service
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Florida
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Jacksonville, Florida, Verenigde Staten, 32256
- Clinical Neuroscience Solutions Inc
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Melbourne, Florida, Verenigde Staten, 32940
- Compass Research
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Miami, Florida, Verenigde Staten, 33175
- New Horizon Research Center
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Miami, Florida, Verenigde Staten, 33173
- Florida International Research Center
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Miami, Florida, Verenigde Staten, 33176
- The Neurology Research Group, LLC
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New Port Richey, Florida, Verenigde Staten, 34652
- Suncoast Clinical Research
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Ocala, Florida, Verenigde Staten, 34470
- Renstar Medical Research
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Ocoee, Florida, Verenigde Staten, 34761
- Sensible Healthcare
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Spring Hill, Florida, Verenigde Staten, 34609
- Meridien Research
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Tampa, Florida, Verenigde Staten, 33609
- Axiom Research
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Georgia
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Gainesville, Georgia, Verenigde Staten, 30501
- United Osteoporosis Center
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Indiana
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Fort Wayne, Indiana, Verenigde Staten, 46804
- Fort Wayne Neurological Center
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Indianapolis, Indiana, Verenigde Staten, 46202
- Indiana University School of Medicine
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Kansas
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Topeka, Kansas, Verenigde Staten, 66606
- Cotton O'Neil Clinic
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Wichita, Kansas, Verenigde Staten, 67205
- Heartland Research Associates
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21224
- Johns Hopkins University School Of Medicine
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Massachusetts
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Newton, Massachusetts, Verenigde Staten, 02459
- Boston Center for Memory
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Missouri
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Bolivar, Missouri, Verenigde Staten, 65613
- Missouri Memory Center
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Chesterfield, Missouri, Verenigde Staten, 63005
- Clinical Research Professionals
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Creve Coeur, Missouri, Verenigde Staten, 63141
- Millenium Psychiatric Associates LLC
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Kansas City, Missouri, Verenigde Staten, 64111
- St Lukes Hospital
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Saint Louis, Missouri, Verenigde Staten, 63108
- Washington University School of Medicine
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Nevada
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Las Vegas, Nevada, Verenigde Staten, 89113
- Las Vegas Medical Research
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New Jersey
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Eatontown, New Jersey, Verenigde Staten, 07724
- Memory Enhancement Center of America, Inc.
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Monroe, New Jersey, Verenigde Staten, 08831
- Pyramid Clinical Research
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Toms River, New Jersey, Verenigde Staten, 08755
- Advanced Memory Research Institute of New Jersey
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Toms River, New Jersey, Verenigde Staten, 08755
- Bio Behavioral Health
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New York
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Albany, New York, Verenigde Staten, 12206
- Albany Medical College
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Amherst, New York, Verenigde Staten, 14226
- Dent Neurological Institute
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Ohio
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Centerville, Ohio, Verenigde Staten, 45459
- Valley Medical Primary Care
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Dayton, Ohio, Verenigde Staten, 45417
- University of Cincinnati Health Neurology
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Dayton, Ohio, Verenigde Staten, 45459
- Neurology Diagnostics, Inc.
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Shaker Heights, Ohio, Verenigde Staten, 44122
- Insight Clinical Trials
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Pennsylvania
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Abington, Pennsylvania, Verenigde Staten, 19090
- Abington Neurological Associates
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Allentown, Pennsylvania, Verenigde Staten, 18104
- Lehigh Center For Clinical Research
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Jenkintown, Pennsylvania, Verenigde Staten, 19046
- Clinical Trial Center, LLC, Psychiatry
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South Carolina
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Charleston, South Carolina, Verenigde Staten, 29406
- Clinical Trials of South Carolina
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Texas
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Dallas, Texas, Verenigde Staten, 75231
- Baylor AT&T Memory Center
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Houston, Texas, Verenigde Staten, 77030
- Nantz National Alzheimer Center
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Houston, Texas, Verenigde Staten, 77054
- University of Texas Health Services Center - Houston
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
55 jaar tot 85 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Dose 1 LY3202626
3 mg LY3202626 given orally once daily for 52 weeks.
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Oraal toegediend
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Experimenteel: Dose 2 LY3202626
12 mg LY3202626 given orally once daily for 52 weeks.
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Oraal toegediend
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Experimenteel: Placebo
Placebo given orally once daily for 52 weeks.
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Oraal toegediend
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change From Baseline in ¹⁸F-AV-1451 Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at 52 Weeks
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Percentage of Participants With Emergent Magnetic Resonance Imaging (MRI) Findings
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
16 juni 2016
Primaire voltooiing (Werkelijk)
2 juli 2018
Studie voltooiing (Werkelijk)
2 juli 2018
Studieregistratiedata
Eerst ingediend
1 juni 2016
Eerst ingediend dat voldeed aan de QC-criteria
1 juni 2016
Eerst geplaatst (Schatting)
6 juni 2016
Updates van studierecords
Laatste update geplaatst (Werkelijk)
19 april 2021
Laatste update ingediend die voldeed aan QC-criteria
22 maart 2021
Laatst geverifieerd
1 maart 2021
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 16223
- I7X-MC-LLCF (Andere identificatie: Eli Lilly and Company)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Ja
Beschrijving IPD-plan
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-tijdsbestek voor delen
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-toegangscriteria voor delen
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD delen Ondersteunend informatietype
- Leerprotocool
- Statistisch Analyse Plan (SAP)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .