A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia (NAVIGATE-AD)
22 marzo 2021 aggiornato da: 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.
Panoramica dello studio
Stato
Terminato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
316
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Box Hill, Australia, 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, Australia, 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, Australia, 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, Australia, 2250
- 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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Glen Iris, Australia, 3146
- 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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Heidelberg, Australia, 3084
- 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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Herston, Australia, 4029
- 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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Nedlands, Australia, 6009
- 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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Parkville, Australia, 3050
- 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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West Perth, Australia, 6005
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Gatineau, Canada, 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, Canada, KIN 5C8
- 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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Verdun, Canada, H4H 1R3
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Akashi, Giappone, 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, Giappone, 193-0998
- 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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Ikeda, Giappone, 563-0058
- 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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Kasukabe-shi, Giappone, 344-0036
- 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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Kyoto, Giappone, 606-0851
- 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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Nagoya, Giappone, 451-8511
- 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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Nerima-ku, Giappone, 179-0072
- 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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Osaka, Giappone, 533-0004
- 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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Osaka, Giappone, 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, Giappone, 158-8531
- 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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Takamatsu, Giappone, 760-8557
- 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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Tokyo, Giappone, 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, Giappone, 351-0111
- 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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Yokosuka-shi, Giappone, 238-0042
- 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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California
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Irvine, California, Stati Uniti, 92614
- Irvine Clinical Research Center
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Sacramento, California, Stati Uniti, 95816
- Sutter Medical Group
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San Diego, California, Stati Uniti, 92123
- Sharp Mesa Vista Hospital
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San Diego, California, Stati Uniti, 92103
- Pacific Research Network Inc
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San Francisco, California, Stati Uniti, 94114
- Ray Dolby Brain Health Center/Sutter Health/CPMC
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Santa Ana, California, Stati Uniti, 92705
- Syrentis Clinical Research
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Sebastopol, California, Stati Uniti, 95472
- North Bay Neuroscience Institute
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Connecticut
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Stamford, Connecticut, Stati Uniti, 06905
- New England Institute for Clinical Research
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Delaware
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Wilmington, Delaware, Stati Uniti, 19801
- Christiana Care Health Service
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Florida
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Jacksonville, Florida, Stati Uniti, 32256
- Clinical NeuroScience Solutions Inc
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Melbourne, Florida, Stati Uniti, 32940
- Compass Research
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Miami, Florida, Stati Uniti, 33175
- New Horizon Research Center
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Miami, Florida, Stati Uniti, 33173
- Florida International Research Center
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Miami, Florida, Stati Uniti, 33176
- The Neurology Research Group, LLC
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New Port Richey, Florida, Stati Uniti, 34652
- Suncoast Clinical Research
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Ocala, Florida, Stati Uniti, 34470
- Renstar Medical Research
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Ocoee, Florida, Stati Uniti, 34761
- Sensible Healthcare
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Spring Hill, Florida, Stati Uniti, 34609
- Meridien Research
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Tampa, Florida, Stati Uniti, 33609
- Axiom Research
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Georgia
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Gainesville, Georgia, Stati Uniti, 30501
- United Osteoporosis Center
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Indiana
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Fort Wayne, Indiana, Stati Uniti, 46804
- Fort Wayne Neurological Center
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Indianapolis, Indiana, Stati Uniti, 46202
- Indiana University School of Medicine
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Kansas
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Topeka, Kansas, Stati Uniti, 66606
- Cotton O'Neil Clinic
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Wichita, Kansas, Stati Uniti, 67205
- Heartland Research Associates
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Maryland
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Baltimore, Maryland, Stati Uniti, 21224
- Johns Hopkins University School of Medicine
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Massachusetts
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Newton, Massachusetts, Stati Uniti, 02459
- Boston Center for Memory
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Missouri
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Bolivar, Missouri, Stati Uniti, 65613
- Missouri Memory Center
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Chesterfield, Missouri, Stati Uniti, 63005
- Clinical Research Professionals
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Creve Coeur, Missouri, Stati Uniti, 63141
- Millenium Psychiatric Associates LLC
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Kansas City, Missouri, Stati Uniti, 64111
- St Lukes Hospital
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Saint Louis, Missouri, Stati Uniti, 63108
- Washington University School of Medicine
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89113
- Las Vegas Medical Research
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New Jersey
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Eatontown, New Jersey, Stati Uniti, 07724
- Memory Enhancement Center of America, Inc.
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Monroe, New Jersey, Stati Uniti, 08831
- Pyramid Clinical Research
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Toms River, New Jersey, Stati Uniti, 08755
- Advanced Memory Research Institute of New Jersey
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Toms River, New Jersey, Stati Uniti, 08755
- Bio Behavioral Health
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New York
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Albany, New York, Stati Uniti, 12206
- Albany Medical College
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Amherst, New York, Stati Uniti, 14226
- Dent Neurological Institute
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Ohio
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Centerville, Ohio, Stati Uniti, 45459
- Valley Medical Primary Care
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Dayton, Ohio, Stati Uniti, 45417
- University of Cincinnati Health Neurology
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Dayton, Ohio, Stati Uniti, 45459
- Neurology Diagnostics, Inc.
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Shaker Heights, Ohio, Stati Uniti, 44122
- Insight Clinical Trials
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Pennsylvania
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Abington, Pennsylvania, Stati Uniti, 19090
- Abington Neurological Associates
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Allentown, Pennsylvania, Stati Uniti, 18104
- Lehigh Center for Clinical Research
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Jenkintown, Pennsylvania, Stati Uniti, 19046
- Clinical Trial Center, LLC, Psychiatry
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29406
- Clinical Trials of South Carolina
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Texas
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Dallas, Texas, Stati Uniti, 75231
- Baylor AT&T Memory Center
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Houston, Texas, Stati Uniti, 77030
- Nantz National Alzheimer Center
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Houston, Texas, Stati Uniti, 77054
- University of Texas Health Services Center - Houston
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 55 anni a 85 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Dose 1 LY3202626
3 mg LY3202626 given orally once daily for 52 weeks.
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Somministrato per via orale
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Sperimentale: Dose 2 LY3202626
12 mg LY3202626 given orally once daily for 52 weeks.
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Somministrato per via orale
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Sperimentale: Placebo
Placebo given orally once daily for 52 weeks.
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Somministrato per via orale
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change From Baseline in ¹⁸F-AV-1451 Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at 52 Weeks
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of Participants With Emergent Magnetic Resonance Imaging (MRI) Findings
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
16 giugno 2016
Completamento primario (Effettivo)
2 luglio 2018
Completamento dello studio (Effettivo)
2 luglio 2018
Date di iscrizione allo studio
Primo inviato
1 giugno 2016
Primo inviato che soddisfa i criteri di controllo qualità
1 giugno 2016
Primo Inserito (Stima)
6 giugno 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
19 aprile 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
22 marzo 2021
Ultimo verificato
1 marzo 2021
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 16223
- I7X-MC-LLCF (Altro identificatore: Eli Lilly and Company)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Sì
Descrizione del piano 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.
Periodo di condivisione 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.
Criteri di accesso alla condivisione IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Tipo di informazioni di supporto alla condivisione IPD
- Protocollo di studio
- Piano di analisi statistica (SAP)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .