A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia (NAVIGATE-AD)
maanantai 22. maaliskuuta 2021 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
316
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Box Hill, Australia, 3128
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Chermside, Australia, 4032
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Darlinghurst, Australia, 2010
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Erina, Australia, 2250
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Glen Iris, Australia, 3146
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Heidelberg, Australia, 3084
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Herston, Australia, 4029
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Nedlands, Australia, 6009
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Parkville, Australia, 3050
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West Perth, Australia, 6005
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Akashi, Japani, 673-0891
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Hachioji, Japani, 193-0998
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Ikeda, Japani, 563-0058
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Kasukabe-shi, Japani, 344-0036
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Kyoto, Japani, 606-0851
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Nagoya, Japani, 451-8511
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Nerima-ku, Japani, 179-0072
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Osaka, Japani, 533-0004
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Osaka, Japani, 559-0004
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Setagaya-ku, Japani, 158-8531
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Takamatsu, Japani, 760-8557
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Tokyo, Japani, 156-0041
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Wako, Japani, 351-0111
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Yokosuka-shi, Japani, 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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California
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Irvine, California, Yhdysvallat, 92614
- Irvine Clinical Research Center
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Sacramento, California, Yhdysvallat, 95816
- Sutter Medical Group
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San Diego, California, Yhdysvallat, 92123
- Sharp Mesa Vista Hospital
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San Diego, California, Yhdysvallat, 92103
- Pacific Research Network Inc
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San Francisco, California, Yhdysvallat, 94114
- Ray Dolby Brain Health Center/Sutter Health/CPMC
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Santa Ana, California, Yhdysvallat, 92705
- Syrentis Clinical Research
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Sebastopol, California, Yhdysvallat, 95472
- North Bay Neuroscience Institute
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Connecticut
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Stamford, Connecticut, Yhdysvallat, 06905
- New England Institute for Clinical Research
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Delaware
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Wilmington, Delaware, Yhdysvallat, 19801
- Christiana Care Health Service
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Florida
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Jacksonville, Florida, Yhdysvallat, 32256
- Clinical NeuroScience Solutions Inc
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Melbourne, Florida, Yhdysvallat, 32940
- Compass Research
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Miami, Florida, Yhdysvallat, 33175
- New Horizon Research Center
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Miami, Florida, Yhdysvallat, 33173
- Florida International Research Center
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Miami, Florida, Yhdysvallat, 33176
- The Neurology Research Group, LLC
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New Port Richey, Florida, Yhdysvallat, 34652
- Suncoast Clinical Research
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Ocala, Florida, Yhdysvallat, 34470
- Renstar Medical Research
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Ocoee, Florida, Yhdysvallat, 34761
- Sensible Healthcare
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Spring Hill, Florida, Yhdysvallat, 34609
- Meridien Research
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Tampa, Florida, Yhdysvallat, 33609
- Axiom Research
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Georgia
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Gainesville, Georgia, Yhdysvallat, 30501
- United Osteoporosis Center
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Indiana
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Fort Wayne, Indiana, Yhdysvallat, 46804
- Fort Wayne Neurological Center
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Indianapolis, Indiana, Yhdysvallat, 46202
- Indiana University School of Medicine
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Kansas
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Topeka, Kansas, Yhdysvallat, 66606
- Cotton O'Neil Clinic
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Wichita, Kansas, Yhdysvallat, 67205
- Heartland Research Associates
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Maryland
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Baltimore, Maryland, Yhdysvallat, 21224
- Johns Hopkins University School of Medicine
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Massachusetts
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Newton, Massachusetts, Yhdysvallat, 02459
- Boston Center for Memory
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Missouri
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Bolivar, Missouri, Yhdysvallat, 65613
- Missouri Memory Center
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Chesterfield, Missouri, Yhdysvallat, 63005
- Clinical Research Professionals
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Creve Coeur, Missouri, Yhdysvallat, 63141
- Millenium Psychiatric Associates LLC
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Kansas City, Missouri, Yhdysvallat, 64111
- St Lukes Hospital
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Saint Louis, Missouri, Yhdysvallat, 63108
- Washington University School of Medicine
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Nevada
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Las Vegas, Nevada, Yhdysvallat, 89113
- Las Vegas Medical Research
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New Jersey
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Eatontown, New Jersey, Yhdysvallat, 07724
- Memory Enhancement Center of America, Inc.
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Monroe, New Jersey, Yhdysvallat, 08831
- Pyramid Clinical Research
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Toms River, New Jersey, Yhdysvallat, 08755
- Advanced Memory Research Institute of New Jersey
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Toms River, New Jersey, Yhdysvallat, 08755
- Bio Behavioral Health
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New York
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Albany, New York, Yhdysvallat, 12206
- Albany Medical College
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Amherst, New York, Yhdysvallat, 14226
- Dent Neurological Institute
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Ohio
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Centerville, Ohio, Yhdysvallat, 45459
- Valley Medical Primary Care
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Dayton, Ohio, Yhdysvallat, 45417
- University of Cincinnati Health Neurology
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Dayton, Ohio, Yhdysvallat, 45459
- Neurology Diagnostics, Inc.
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Shaker Heights, Ohio, Yhdysvallat, 44122
- Insight Clinical Trials
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Pennsylvania
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Abington, Pennsylvania, Yhdysvallat, 19090
- Abington Neurological Associates
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Allentown, Pennsylvania, Yhdysvallat, 18104
- Lehigh Center for Clinical Research
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Jenkintown, Pennsylvania, Yhdysvallat, 19046
- Clinical Trial Center, LLC, Psychiatry
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South Carolina
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Charleston, South Carolina, Yhdysvallat, 29406
- Clinical Trials of South Carolina
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Texas
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Dallas, Texas, Yhdysvallat, 75231
- Baylor AT&T Memory Center
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Houston, Texas, Yhdysvallat, 77030
- Nantz National Alzheimer Center
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Houston, Texas, Yhdysvallat, 77054
- University of Texas Health Services Center - Houston
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
55 vuotta - 85 vuotta (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kolminkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: Dose 1 LY3202626
3 mg LY3202626 given orally once daily for 52 weeks.
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Annostetaan suun kautta
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Kokeellinen: Dose 2 LY3202626
12 mg LY3202626 given orally once daily for 52 weeks.
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Annostetaan suun kautta
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Kokeellinen: Placebo
Placebo given orally once daily for 52 weeks.
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Annostetaan suun kautta
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change From Baseline in ¹⁸F-AV-1451 Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at 52 Weeks
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Percentage of Participants With Emergent Magnetic Resonance Imaging (MRI) Findings
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Torstai 16. kesäkuuta 2016
Ensisijainen valmistuminen (Todellinen)
Maanantai 2. heinäkuuta 2018
Opintojen valmistuminen (Todellinen)
Maanantai 2. heinäkuuta 2018
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Keskiviikko 1. kesäkuuta 2016
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 1. kesäkuuta 2016
Ensimmäinen Lähetetty (Arvio)
Maanantai 6. kesäkuuta 2016
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Maanantai 19. huhtikuuta 2021
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Maanantai 22. maaliskuuta 2021
Viimeksi vahvistettu
Maanantai 1. maaliskuuta 2021
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 16223
- I7X-MC-LLCF (Muu tunniste: Eli Lilly and Company)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Joo
IPD-suunnitelman kuvaus
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-jaon aikakehys
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-jaon käyttöoikeuskriteerit
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD-jakamista tukeva tietotyyppi
- Tutkimuspöytäkirja
- Tilastollinen analyysisuunnitelma (SAP)
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .