A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia (NAVIGATE-AD)
22. března 2021 aktualizováno: 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.
Přehled studie
Typ studie
Intervenční
Zápis (Aktuální)
316
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Box Hill, Austrálie, 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, Austrálie, 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, Austrálie, 2010
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Erina, Austrálie, 2250
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Glen Iris, Austrálie, 3146
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Heidelberg, Austrálie, 3084
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Herston, Austrálie, 4029
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Nedlands, Austrálie, 6009
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Parkville, Austrálie, 3050
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West Perth, Austrálie, 6005
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Akashi, Japonsko, 673-0891
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Hachioji, Japonsko, 193-0998
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Ikeda, Japonsko, 563-0058
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Kasukabe-shi, Japonsko, 344-0036
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Kyoto, Japonsko, 606-0851
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Nagoya, Japonsko, 451-8511
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Nerima-ku, Japonsko, 179-0072
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Osaka, Japonsko, 533-0004
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Osaka, Japonsko, 559-0004
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Setagaya-ku, Japonsko, 158-8531
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Takamatsu, Japonsko, 760-8557
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Tokyo, Japonsko, 156-0041
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Wako, Japonsko, 351-0111
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Yokosuka-shi, Japonsko, 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, Spojené státy, 92614
- Irvine Clinical Research Center
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Sacramento, California, Spojené státy, 95816
- Sutter Medical Group
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San Diego, California, Spojené státy, 92123
- Sharp Mesa Vista Hospital
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San Diego, California, Spojené státy, 92103
- Pacific Research Network Inc
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San Francisco, California, Spojené státy, 94114
- Ray Dolby Brain Health Center/Sutter Health/CPMC
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Santa Ana, California, Spojené státy, 92705
- Syrentis Clinical Research
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Sebastopol, California, Spojené státy, 95472
- North Bay Neuroscience Institute
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Connecticut
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Stamford, Connecticut, Spojené státy, 06905
- New England Institute for Clinical Research
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Delaware
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Wilmington, Delaware, Spojené státy, 19801
- Christiana Care Health Service
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Florida
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Jacksonville, Florida, Spojené státy, 32256
- Clinical NeuroScience Solutions Inc
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Melbourne, Florida, Spojené státy, 32940
- Compass Research
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Miami, Florida, Spojené státy, 33175
- New Horizon Research Center
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Miami, Florida, Spojené státy, 33173
- Florida International Research Center
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Miami, Florida, Spojené státy, 33176
- The Neurology Research Group, LLC
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New Port Richey, Florida, Spojené státy, 34652
- Suncoast Clinical Research
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Ocala, Florida, Spojené státy, 34470
- Renstar Medical Research
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Ocoee, Florida, Spojené státy, 34761
- Sensible Healthcare
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Spring Hill, Florida, Spojené státy, 34609
- Meridien Research
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Tampa, Florida, Spojené státy, 33609
- Axiom Research
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Georgia
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Gainesville, Georgia, Spojené státy, 30501
- United Osteoporosis Center
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Indiana
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Fort Wayne, Indiana, Spojené státy, 46804
- Fort Wayne Neurological Center
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Indianapolis, Indiana, Spojené státy, 46202
- Indiana University School of Medicine
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Kansas
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Topeka, Kansas, Spojené státy, 66606
- Cotton O'Neil Clinic
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Wichita, Kansas, Spojené státy, 67205
- Heartland Research Associates
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Maryland
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Baltimore, Maryland, Spojené státy, 21224
- Johns Hopkins University School of Medicine
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Massachusetts
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Newton, Massachusetts, Spojené státy, 02459
- Boston Center for Memory
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Missouri
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Bolivar, Missouri, Spojené státy, 65613
- Missouri Memory Center
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Chesterfield, Missouri, Spojené státy, 63005
- Clinical Research Professionals
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Creve Coeur, Missouri, Spojené státy, 63141
- Millenium Psychiatric Associates LLC
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Kansas City, Missouri, Spojené státy, 64111
- St Lukes Hospital
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Saint Louis, Missouri, Spojené státy, 63108
- Washington University School of Medicine
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Nevada
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Las Vegas, Nevada, Spojené státy, 89113
- Las Vegas Medical Research
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New Jersey
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Eatontown, New Jersey, Spojené státy, 07724
- Memory Enhancement Center of America, Inc.
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Monroe, New Jersey, Spojené státy, 08831
- Pyramid Clinical Research
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Toms River, New Jersey, Spojené státy, 08755
- Advanced Memory Research Institute of New Jersey
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Toms River, New Jersey, Spojené státy, 08755
- Bio Behavioral Health
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New York
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Albany, New York, Spojené státy, 12206
- Albany Medical College
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Amherst, New York, Spojené státy, 14226
- Dent Neurological Institute
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Ohio
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Centerville, Ohio, Spojené státy, 45459
- Valley Medical Primary Care
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Dayton, Ohio, Spojené státy, 45417
- University of Cincinnati Health Neurology
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Dayton, Ohio, Spojené státy, 45459
- Neurology Diagnostics, Inc.
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Shaker Heights, Ohio, Spojené státy, 44122
- Insight Clinical Trials
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Pennsylvania
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Abington, Pennsylvania, Spojené státy, 19090
- Abington Neurological Associates
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Allentown, Pennsylvania, Spojené státy, 18104
- Lehigh Center for Clinical Research
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Jenkintown, Pennsylvania, Spojené státy, 19046
- Clinical Trial Center, LLC, Psychiatry
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South Carolina
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Charleston, South Carolina, Spojené státy, 29406
- Clinical Trials of South Carolina
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Texas
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Dallas, Texas, Spojené státy, 75231
- Baylor AT&T Memory Center
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Houston, Texas, Spojené státy, 77030
- Nantz National Alzheimer Center
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Houston, Texas, Spojené státy, 77054
- University of Texas Health Services Center - Houston
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
55 let až 85 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Dose 1 LY3202626
3 mg LY3202626 given orally once daily for 52 weeks.
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Podává se ústně
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Experimentální: Dose 2 LY3202626
12 mg LY3202626 given orally once daily for 52 weeks.
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Podává se ústně
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Experimentální: Placebo
Placebo given orally once daily for 52 weeks.
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Podává se ústně
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change From Baseline in ¹⁸F-AV-1451 Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at 52 Weeks
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage of Participants With Emergent Magnetic Resonance Imaging (MRI) Findings
Časové okno: Week 52
|
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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Baseline, Week 52
|
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)
Časové okno: 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)
Časové okno: 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.
|
Baseline, Week 52
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Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
16. června 2016
Primární dokončení (Aktuální)
2. července 2018
Dokončení studie (Aktuální)
2. července 2018
Termíny zápisu do studia
První předloženo
1. června 2016
První předloženo, které splnilo kritéria kontroly kvality
1. června 2016
První zveřejněno (Odhad)
6. června 2016
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
19. dubna 2021
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
22. března 2021
Naposledy ověřeno
1. března 2021
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 16223
- I7X-MC-LLCF (Jiný identifikátor: Eli Lilly and Company)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Ano
Popis plánu 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.
Časový rámec sdílení 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.
Kritéria přístupu pro sdílení IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Typ podpůrných informací pro sdílení IPD
- Protokol studie
- Plán statistické analýzy (SAP)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .