Effect van LY2062430 op de progressie van de ziekte van Alzheimer (EXPEDITION2)
11 december 2012 bijgewerkt door: Eli Lilly and Company
Effect van passieve immunisatie op de progressie van de ziekte van Alzheimer: LY2062430 versus placebo
De ziekte van Alzheimer (AD) is een leeftijdsgebonden degeneratieve aandoening van de hersenen, gekenmerkt door progressieve achteruitgang van de cognitieve functie en het vermogen om dagelijkse activiteiten uit te voeren, en kan uiteindelijk leiden tot de dood als gevolg van complicaties van de ziekte. Aangenomen wordt dat AD wordt veroorzaakt door een teveel aan A-Beta-amyloïde, een plakkerig eiwit in de hersenen dat amyloïde plaques vormt. Van behandelingen die de synthese of afzetting van A-Beta-amyloïde vertragen, of die de klaring verhogen, kan worden verwacht dat ze de progressie van AD vertragen.
LY2062430 (solanezumab) is een gehumaniseerd anti-A Beta-peptide immunoglobuline G-1 (IgG1) monoklonaal antilichaam dat wordt ontwikkeld voor de behandeling van AD. De primaire hypothese die wordt getest, is dat LY2062430 de cognitieve en functionele achteruitgang bij AD zal vertragen in vergelijking met placebo. De deelname van elke patiënt duurt ongeveer 19 maanden. Patiënten die goedgekeurde AD-medicatie gebruiken, kunnen deelnemen aan deze studie en deze medicijnen blijven gebruiken tijdens de studie.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
1040
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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New South Wales
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Bankstown, New South Wales, Australië, 2200
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Darlinghurst, New South Wales, Australië, 2010
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Gosford, New South Wales, Australië, 2250
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Kogarah, New South Wales, Australië, 2217
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Queensland
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Chermside, Queensland, Australië, 4032
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Toowoomba, Queensland, Australië, 4650
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Victoria
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Box Hill, Victoria, Australië, 3128
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Glen Iris, Victoria, Australië, 3146
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Heidelberg Heights, Victoria, Australië, 3081
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Melbourne, Victoria, Australië, 3004
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Western Australia
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Subiaco, Western Australia, Australië, 6008
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Berlin, Duitsland, D-12200
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Hamburg, Duitsland, 22307
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Hannover, Duitsland, 30559
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Mannheim, Duitsland, 68165
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Marburg, Duitsland, 35033
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Munchen, Duitsland, BY 80336
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München, Duitsland, D-81675
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Regensburg, Duitsland, 93042
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Aix En Provence, Frankrijk, 13100
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Paris, Frankrijk, 75475
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Rennes, Frankrijk, 35000
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Strasbourg, Frankrijk, 67091
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Toulouse, Frankrijk, 31300
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Biella, Italië, 13900
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Boggiovara, Italië, 41100
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Cassino, Italië, 03043
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Chieti, Italië, 66013
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Genova, Italië, 16128
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Lido Di Camaiore, Italië, 55043
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Milano, Italië, 20132
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Rome, Italië, 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, republiek van, 400-711
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Seongnam-Si, Korea, republiek van, 463-707
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Seoul, Korea, republiek van, 143-729
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Suwon, Korea, republiek van, 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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Chelyabinsk, Russische Federatie, 454091
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Ekaterinburg, Russische Federatie, 620030
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Rostov-On-Don, Russische Federatie, 344010
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Saint Petersburg, Russische Federatie, 190021
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Barcelona, Spanje, 08014
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Getafe, Spanje, 28905
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Madrid, Spanje, 28034
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Plasencia, Spanje, 10600
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Terrassa, Spanje, 0821
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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
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Yung-Kang, Tainan, Taiwan, 710
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E Susx
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Uckfield, E Susx, Verenigd Koninkrijk, TN225AW
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Glasgow
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Scotland, Glasgow, Verenigd Koninkrijk, G20 0XA
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Greater London
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London, Greater London, Verenigd Koninkrijk, N195NX
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London
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Camberwell, London, Verenigd Koninkrijk, SE5 8AF
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Syorks
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Sheffield, Syorks, Verenigd Koninkrijk, S57JT
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Wiltshire
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Swindon, Wiltshire, Verenigd Koninkrijk, SN3 6BW
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Arizona
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Tucson, Arizona, Verenigde Staten, 85741
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California
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Los Angeles, California, Verenigde Staten, 90033
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San Diego, California, Verenigde Staten, 92103
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San Francisco, California, Verenigde Staten, 94109
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Santa Monica, California, Verenigde Staten, 90404
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Connecticut
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New Haven, Connecticut, Verenigde Staten, 06510
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Florida
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Miami, Florida, Verenigde Staten, 33137
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Tampa Bay, Florida, Verenigde Staten, 33613
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Mississippi
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Hattiesburg, Mississippi, Verenigde Staten, 39401
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Missouri
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Creve Coeur, Missouri, Verenigde Staten, 63141
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Kansas City, Missouri, Verenigde Staten, 64114
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New York
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Amherst, New York, Verenigde Staten, 14226
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Staten Island, New York, Verenigde Staten, 10312
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Oregon
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Portland, Oregon, Verenigde Staten, 97210
- 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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Texas
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San Antonio, Texas, Verenigde Staten, 78229
- 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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Washington
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Seattle, Washington, Verenigde Staten, 98108
- 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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Joenkoeping, Zweden, 551 85
- 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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Kalmar, Zweden, 39185
- 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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Lund, Zweden, 22241
- 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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Malmo, Zweden, 20502
- 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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Molndal, Zweden, 43135
- 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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Stockholm, Zweden, 14186
- 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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Umea, Zweden, 901 85
- 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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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
55 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusiecriteria:
- Voldoet aan criteria voor milde tot matige ziekte van Alzheimer (AD) met Mini-Mental State Examination-score van 16 tot 26 bij screening
- Gemodificeerde Hachinski Ischemieschaalscore van minder dan of gelijk aan 4
- Geriatrische depressieschaalscore van minder dan of gelijk aan 6
- Een magnetische resonantie beeldvorming (MRI) of computertomografie (CT) scan in de afgelopen 2 jaar zonder bevindingen die niet consistent zijn met een diagnose van AD
- Als u gelijktijdig AD-behandeling krijgt, moet u de medicatie gedurende ten minste 4 maanden in een stabiele dosis hebben ingenomen gedurende ten minste 2 maanden voorafgaand aan randomisatie
Uitsluitingscriteria:
- Heeft ernstige of onstabiele ziekte(s)
- Heeft geen betrouwbare zorgverlener die regelmatig contact heeft met de patiënt (minstens 10 uur per week)
- Voldoet aan de criteria van het National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) voor vasculaire dementie
- Heeft geen goede veneuze toegang, zodat intraveneuze (IV) medicijntoediening moeilijk zou zijn
- Heeft in de afgelopen 5 jaar meerdere episodes van hoofdtrauma gehad of een voorgeschiedenis van een ernstige besmettelijke ziekte die de hersenen aantast
- Heeft allergieën voor gehumaniseerde monoklonale antilichamen
- Chronisch alcohol- en/of drugsmisbruik in de afgelopen 5 jaar
- Heeft contra-indicaties voor MRI-onderzoeken
- Vereist behandeling met een ander monoklonaal antilichaam
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Placebo-vergelijker: Placebo
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intraveneus (IV) elke 4 weken gedurende 80 weken
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Experimenteel: LY2062430
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400 mg intraveneus (IV) elke 4 weken gedurende 80 weken
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Verandering van baseline naar week 80 in de beoordelingsschaal voor de ziekte van Alzheimer - Cognitieve subscore-schaal met 14 items (ADAS-Cog14)
Tijdsspanne: Basislijn, week 80
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Basislijn, week 80
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Verandering van baseline naar week 80 in klinische dementiescore - Sum of Boxes (CDR-SB)-score
Tijdsspanne: Basislijn, week 80
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Basislijn, week 80
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Verandering van basislijn naar week 80 in Neuropsychiatric Inventory (NPI) Score
Tijdsspanne: Basislijn, week 80
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Basislijn, week 80
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Verandering van baseline naar week 80 in volumetrische magnetische resonantiebeeldvorming (vMRI)
Tijdsspanne: Basislijn, week 80
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Basislijn, week 80
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Verandering van baseline naar week 80 in Mini-Mental State Examination (MMSE) Score
Tijdsspanne: Basislijn, week 80
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Basislijn, week 80
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Verandering van baseline naar week 80 in resourcegebruik bij dementie - Lite (RUD-Lite)-score
Tijdsspanne: Basislijn, week 80
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Basislijn, week 80
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Verandering van Baseline naar Week 80 in EuroQol 5-Dimensional Health-related Quality of Life Scale Proxy-score (EQ-5D Proxy) Score
Tijdsspanne: Basislijn, week 80
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Basislijn, week 80
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Verandering van baseline tot week 80 in de score voor kwaliteit van leven bij de ziekte van Alzheimer (QoL-AD).
Tijdsspanne: Basislijn, week 80
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Basislijn, week 80
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Verandering van basislijn naar week 80 in amyloïde-bètaspiegels in plasma
Tijdsspanne: Basislijn, week 80
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Basislijn, week 80
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Verandering van baseline naar week 80 in de beoordelingsschaal voor de ziekte van Alzheimer - Cognitieve subscore 11-item en 12-item schaal (ADAS-Cog11 en ADAS-Cog12)
Tijdsspanne: Basislijn, week 80
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Basislijn, week 80
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Verandering van baseline naar week 80 in coöperatieve studie bij de ziekte van Alzheimer - Score van activiteiten van het dagelijks leven (ADCS-ADL)
Tijdsspanne: Basislijn, week 80
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Basislijn, week 80
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: 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
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 mei 2009
Primaire voltooiing (Werkelijk)
1 juni 2012
Studie voltooiing (Werkelijk)
1 juni 2012
Studieregistratiedata
Eerst ingediend
18 mei 2009
Eerst ingediend dat voldeed aan de QC-criteria
18 mei 2009
Eerst geplaatst (Schatting)
20 mei 2009
Updates van studierecords
Laatste update geplaatst (Schatting)
13 december 2012
Laatste update ingediend die voldeed aan QC-criteria
11 december 2012
Laatst geverifieerd
1 december 2012
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 11934
- H8A-MC-LZAN (Andere identificatie: Eli Lilly and Company)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .