Effekt av LY2062430 på progresjon av Alzheimers sykdom (EXPEDITION2)
11. desember 2012 oppdatert av: Eli Lilly and Company
Effekt av passiv immunisering på progresjon av Alzheimers sykdom: LY2062430 versus placebo
Alzheimers sykdom (AD) er en aldersrelatert degenerativ lidelse i hjernen, preget av progressiv nedgang i kognitiv funksjon og evne til å utføre daglige aktiviteter, og til slutt kan føre til død på grunn av komplikasjoner av sykdommen. AD antas å være forårsaket av et overskudd av A-Beta amyloid, et klebrig protein i hjernen som danner amyloid plakk. Behandlinger som bremser syntesen eller avsetningen av A-Beta-amyloid, eller som øker clearance, kan forventes å bremse utviklingen av AD.
LY2062430 (solanezumab) er et humanisert anti-A Beta peptid immunoglobulin G-1 (IgG1) monoklonalt antistoff som utvikles for behandling av AD. Den primære hypotesen som testes er at LY2062430 vil bremse kognitiv og funksjonell nedgang i AD sammenlignet med placebo. Hver pasients deltakelse vil vare i omtrent 19 måneder. Pasienter som tar godkjente AD-medisiner kan delta i denne studien og fortsette å ta disse medisinene under studien.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
1040
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New South Wales
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Bankstown, New South Wales, Australia, 2200
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Darlinghurst, New South Wales, Australia, 2010
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Gosford, New South Wales, Australia, 2250
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Kogarah, New South Wales, Australia, 2217
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Queensland
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Chermside, Queensland, Australia, 4032
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Toowoomba, Queensland, Australia, 4650
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Victoria
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Box Hill, Victoria, Australia, 3128
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Glen Iris, Victoria, Australia, 3146
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Heidelberg Heights, Victoria, Australia, 3081
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Melbourne, Victoria, Australia, 3004
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Western Australia
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Subiaco, Western Australia, Australia, 6008
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Chelyabinsk, Den russiske føderasjonen, 454091
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Ekaterinburg, Den russiske føderasjonen, 620030
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Rostov-On-Don, Den russiske føderasjonen, 344010
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Saint Petersburg, Den russiske føderasjonen, 190021
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Arizona
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Tucson, Arizona, Forente stater, 85741
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California
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Los Angeles, California, Forente stater, 90033
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San Diego, California, Forente stater, 92103
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San Francisco, California, Forente stater, 94109
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Santa Monica, California, Forente stater, 90404
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Connecticut
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New Haven, Connecticut, Forente stater, 06510
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Florida
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Miami, Florida, Forente stater, 33137
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Tampa Bay, Florida, Forente stater, 33613
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Mississippi
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Hattiesburg, Mississippi, Forente stater, 39401
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Missouri
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Creve Coeur, Missouri, Forente stater, 63141
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Kansas City, Missouri, Forente stater, 64114
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New York
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Amherst, New York, Forente stater, 14226
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Staten Island, New York, Forente stater, 10312
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Oregon
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Portland, Oregon, Forente stater, 97210
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Texas
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San Antonio, Texas, Forente stater, 78229
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Washington
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Seattle, Washington, Forente stater, 98108
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Aix En Provence, Frankrike, 13100
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Paris, Frankrike, 75475
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Rennes, Frankrike, 35000
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Strasbourg, Frankrike, 67091
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Toulouse, Frankrike, 31300
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Biella, Italia, 13900
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Boggiovara, Italia, 41100
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Cassino, Italia, 03043
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Chieti, Italia, 66013
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Genova, Italia, 16128
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Lido Di Camaiore, Italia, 55043
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Milano, Italia, 20132
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Rome, Italia, 00179
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Ehime, Japan, 791-0295
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Fukuoka, Japan, 816-0864
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Hyogo, Japan, 514-8507
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Kanagawa, Japan, 247-0072
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Kyoto, Japan, 606-0851
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Osaka, Japan, 558-0056
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Shizuoka, Japan, 424-0911
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Tokyo, Japan, 173
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Incheon, Korea, Republikken, 400-711
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Seongnam-Si, Korea, Republikken, 463-707
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Seoul, Korea, Republikken, 143-729
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Suwon, Korea, Republikken, 443-721
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Bialystok, Polen, 15-617
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Bydgoszcz, Polen, 85-796
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Gliwice, Polen, 44-100
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Katowice, Polen, 40-588
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Krakow, Polen, 31-530
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Lublin, Polen, 20-090
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Warsaw, Polen, 02-777
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Barcelona, Spania, 08014
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Getafe, Spania, 28905
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Madrid, Spania, 28034
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Plasencia, Spania, 10600
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Terrassa, Spania, 0821
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E Susx
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Uckfield, E Susx, Storbritannia, TN225AW
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Glasgow
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Scotland, Glasgow, Storbritannia, G20 0XA
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Greater London
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London, Greater London, Storbritannia, N195NX
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London
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Camberwell, London, Storbritannia, SE5 8AF
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Syorks
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Sheffield, Syorks, Storbritannia, S57JT
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Wiltshire
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Swindon, Wiltshire, Storbritannia, SN3 6BW
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Joenkoeping, Sverige, 551 85
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Kalmar, Sverige, 39185
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Lund, Sverige, 22241
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Malmo, Sverige, 20502
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Molndal, Sverige, 43135
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Stockholm, Sverige, 14186
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Umea, Sverige, 901 85
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Kaohsiung, Taiwan, 807
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Niao Sung Hsiang, Taiwan, 83301
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Taichung, Taiwan, 404
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Taipei, Taiwan, 112
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Tao-Yuan, Taiwan, 333
- 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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Yung-Kang, Tainan, Taiwan, 710
- 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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Berlin, Tyskland, D-12200
- 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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Hamburg, Tyskland, 22307
- 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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Hannover, Tyskland, 30559
- 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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Mannheim, Tyskland, 68165
- 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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Marburg, Tyskland, 35033
- 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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Munchen, Tyskland, BY 80336
- 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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München, Tyskland, D-81675
- 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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Regensburg, Tyskland, 93042
- 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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
55 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inklusjonskriterier:
- Oppfyller kriteriene for mild til moderat Alzheimers sykdom (AD) med skåre for mini-mental tilstandsundersøkelse på 16 til 26 ved screening
- Modifisert Hachinski Ischemi Scale-poengsum på mindre enn eller lik 4
- Geriatrisk depresjonsskala poengsum på mindre enn eller lik 6
- En magnetisk resonanstomografi (MRI) eller datastyrt tomografi (CT) skanning i løpet av de siste 2 årene uten funn som er uforenlig med en diagnose av AD
- Hvis du mottar samtidig AD-behandling, må du være på medisinen i minst 4 måneder i en stabil dose i minst 2 måneder før randomisering
Ekskluderingskriterier:
- Har alvorlig eller ustabil sykdom(er)
- Har ikke en pålitelig omsorgsperson som er i hyppig kontakt med pasienten (minst 10 timer per uke)
- Oppfyller National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) kriterier for vaskulær demens
- Har ikke god venøs tilgang, slik at intravenøs (IV) medikamentlevering ville være vanskelig
- Har hatt flere episoder med hodetraumer eller historie i løpet av de siste 5 årene med en alvorlig infeksjonssykdom som påvirker hjernen
- Har allergi mot humaniserte monoklonale antistoffer
- Kronisk alkohol- og/eller narkotikamisbruk de siste 5 årene
- Har noen kontraindikasjoner for MR-studier
- Krever behandling med et annet monoklonalt antistoff
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: Placebo
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intravenøst (IV) hver 4. uke i 80 uker
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Eksperimentell: LY2062430
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400 mg intravenøst (IV) hver 4. uke i 80 uker
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Endring fra baseline til uke 80 i Alzheimers sykdomsvurderingsskala - kognitiv underscore 14-elementskala (ADAS-Cog14)
Tidsramme: Grunnlinje, uke 80
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Grunnlinje, uke 80
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Endring fra baseline til uke 80 i Clinical Dementia Rating – Sum of Boxes (CDR-SB) Score
Tidsramme: Grunnlinje, uke 80
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Grunnlinje, uke 80
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Endring fra baseline til uke 80 i nevropsykiatrisk inventar (NPI) Score
Tidsramme: Grunnlinje, uke 80
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Grunnlinje, uke 80
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Endring fra baseline til uke 80 i volumetrisk magnetisk resonansavbildning (vMRI)
Tidsramme: Grunnlinje, uke 80
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Grunnlinje, uke 80
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Endring fra baseline til uke 80 i Mini-Mental State Examination (MMSE) Score
Tidsramme: Grunnlinje, uke 80
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Grunnlinje, uke 80
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Endring fra baseline til uke 80 i ressursutnyttelse ved demens - Lite (RUD-Lite)-poengsum
Tidsramme: Grunnlinje, uke 80
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Grunnlinje, uke 80
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Endring fra baseline til uke 80 i EuroQol 5-dimensjonal helserelatert livskvalitetsskala Proxy-versjon (EQ-5D Proxy) Score
Tidsramme: Grunnlinje, uke 80
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Grunnlinje, uke 80
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Endring fra baseline til uke 80 i livskvalitet ved Alzheimers sykdom (QoL-AD)
Tidsramme: Grunnlinje, uke 80
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Grunnlinje, uke 80
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Endre fra baseline til uke 80 i plasma amyloid betanivåer
Tidsramme: Grunnlinje, uke 80
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Grunnlinje, uke 80
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Endring fra baseline til uke 80 i Alzheimers sykdomsvurderingsskala - kognitiv underscore 11-element og 12-elementskala (ADAS-Cog11 og ADAS-Cog12)
Tidsramme: Grunnlinje, uke 80
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Grunnlinje, uke 80
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Endring fra baseline til uke 80 i Alzheimers sykdom Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) Score
Tidsramme: Grunnlinje, uke 80
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Grunnlinje, uke 80
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Reed C, Belger M, Dell'Agnello G, Kahle-Wrobleski K, Sethuraman G, Hake A, Raskin J, Henley D. Representativeness of European clinical trial populations in mild Alzheimer's disease dementia: a comparison of 18-month outcomes with real-world data from the GERAS observational study. Alzheimers Res Ther. 2018 Apr 3;10(1):36. doi: 10.1186/s13195-018-0360-4.
- Liu-Seifert H, Siemers E, Price K, Han B, Selzler KJ, Henley D, Sundell K, Aisen P, Cummings J, Raskin J, Mohs R; Alzheimer's Disease Neuroimaging Initiative. Cognitive Impairment Precedes and Predicts Functional Impairment in Mild Alzheimer's Disease. J Alzheimers Dis. 2015;47(1):205-14. doi: 10.3233/JAD-142508.
- Henley DB, Dowsett SA, Chen YF, Liu-Seifert H, Grill JD, Doody RS, Aisen P, Raman R, Miller DS, Hake AM, Cummings J. Alzheimer's disease progression by geographical region in a clinical trial setting. Alzheimers Res Ther. 2015 Jun 25;7(1):43. doi: 10.1186/s13195-015-0127-0. eCollection 2015.
- Liu-Seifert H, Siemers E, Sundell K, Price K, Han B, Selzler K, Aisen P, Cummings J, Raskin J, Mohs R. Cognitive and functional decline and their relationship in patients with mild Alzheimer's dementia. J Alzheimers Dis. 2015;43(3):949-55. doi: 10.3233/JAD-140792.
- Doody RS, Thomas RG, Farlow M, Iwatsubo T, Vellas B, Joffe S, Kieburtz K, Raman R, Sun X, Aisen PS, Siemers E, Liu-Seifert H, Mohs R; Alzheimer's Disease Cooperative Study Steering Committee; Solanezumab Study Group. Phase 3 trials of solanezumab for mild-to-moderate Alzheimer's disease. N Engl J Med. 2014 Jan 23;370(4):311-21. doi: 10.1056/NEJMoa1312889.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2009
Primær fullføring (Faktiske)
1. juni 2012
Studiet fullført (Faktiske)
1. juni 2012
Datoer for studieregistrering
Først innsendt
18. mai 2009
Først innsendt som oppfylte QC-kriteriene
18. mai 2009
Først lagt ut (Anslag)
20. mai 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
13. desember 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. desember 2012
Sist bekreftet
1. desember 2012
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 11934
- H8A-MC-LZAN (Annen identifikator: Eli Lilly and Company)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .