Effet de LY2062430 sur la progression de la maladie d'Alzheimer (EXPEDITION2)
11 décembre 2012 mis à jour par: Eli Lilly and Company
Effet de l'immunisation passive sur la progression de la maladie d'Alzheimer : LY2062430 versus placebo
La maladie d'Alzheimer (MA) est une maladie dégénérative du cerveau liée à l'âge, caractérisée par un déclin progressif de la fonction cognitive et de la capacité à effectuer les activités de la vie quotidienne, et peut finalement entraîner la mort en raison des complications de la maladie. On pense que la MA est causée par un excès d'amyloïde A-bêta, une protéine collante dans le cerveau qui forme des plaques amyloïdes. On peut s'attendre à ce que les traitements qui ralentissent la synthèse ou le dépôt d'amyloïde A-bêta, ou qui augmentent la clairance, ralentissent la progression de la MA.
LY2062430 (solanezumab) est un anticorps monoclonal humanisé anti-peptide A Beta immunoglobuline G-1 (IgG1) en cours de développement pour le traitement de la MA. L'hypothèse principale testée est que LY2062430 ralentira le déclin cognitif et fonctionnel dans la MA par rapport au placebo. La participation de chaque patient durera environ 19 mois. Les patients prenant des médicaments AD approuvés peuvent participer à cette étude et continuer à prendre ces médicaments pendant l'étude.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
1040
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Berlin, Allemagne, D-12200
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Hamburg, Allemagne, 22307
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Hannover, Allemagne, 30559
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Mannheim, Allemagne, 68165
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Marburg, Allemagne, 35033
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Munchen, Allemagne, BY 80336
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München, Allemagne, D-81675
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Regensburg, Allemagne, 93042
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New South Wales
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Bankstown, New South Wales, Australie, 2200
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Darlinghurst, New South Wales, Australie, 2010
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Gosford, New South Wales, Australie, 2250
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Kogarah, New South Wales, Australie, 2217
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Queensland
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Chermside, Queensland, Australie, 4032
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Toowoomba, Queensland, Australie, 4650
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Victoria
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Box Hill, Victoria, Australie, 3128
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Glen Iris, Victoria, Australie, 3146
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Heidelberg Heights, Victoria, Australie, 3081
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Melbourne, Victoria, Australie, 3004
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Western Australia
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Subiaco, Western Australia, Australie, 6008
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Incheon, Corée, République de, 400-711
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Seongnam-Si, Corée, République de, 463-707
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Seoul, Corée, République de, 143-729
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Suwon, Corée, République de, 443-721
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Barcelona, Espagne, 08014
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Getafe, Espagne, 28905
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Madrid, Espagne, 28034
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Plasencia, Espagne, 10600
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Terrassa, Espagne, 0821
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Aix En Provence, France, 13100
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Paris, France, 75475
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Rennes, France, 35000
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Strasbourg, France, 67091
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Toulouse, France, 31300
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Chelyabinsk, Fédération Russe, 454091
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Ekaterinburg, Fédération Russe, 620030
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Rostov-On-Don, Fédération Russe, 344010
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Saint Petersburg, Fédération Russe, 190021
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Biella, Italie, 13900
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Boggiovara, Italie, 41100
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Cassino, Italie, 03043
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Chieti, Italie, 66013
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Genova, Italie, 16128
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Lido Di Camaiore, Italie, 55043
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Milano, Italie, 20132
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Rome, Italie, 00179
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Ehime, Japon, 791-0295
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Fukuoka, Japon, 816-0864
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Hyogo, Japon, 514-8507
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Kanagawa, Japon, 247-0072
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Kyoto, Japon, 606-0851
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Osaka, Japon, 558-0056
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Shizuoka, Japon, 424-0911
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Tokyo, Japon, 173
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Bialystok, Pologne, 15-617
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Bydgoszcz, Pologne, 85-796
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Gliwice, Pologne, 44-100
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Katowice, Pologne, 40-588
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Krakow, Pologne, 31-530
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Lublin, Pologne, 20-090
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Warsaw, Pologne, 02-777
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E Susx
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Uckfield, E Susx, Royaume-Uni, TN225AW
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Glasgow
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Scotland, Glasgow, Royaume-Uni, G20 0XA
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Greater London
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London, Greater London, Royaume-Uni, N195NX
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London
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Camberwell, London, Royaume-Uni, SE5 8AF
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Syorks
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Sheffield, Syorks, Royaume-Uni, S57JT
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Wiltshire
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Swindon, Wiltshire, Royaume-Uni, SN3 6BW
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Joenkoeping, Suède, 551 85
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Kalmar, Suède, 39185
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Lund, Suède, 22241
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Malmo, Suède, 20502
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Molndal, Suède, 43135
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Stockholm, Suède, 14186
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Umea, Suède, 901 85
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Kaohsiung, Taïwan, 807
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Niao Sung Hsiang, Taïwan, 83301
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Taichung, Taïwan, 404
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Taipei, Taïwan, 112
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Tao-Yuan, Taïwan, 333
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Yung-Kang, Tainan, Taïwan, 710
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Arizona
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Tucson, Arizona, États-Unis, 85741
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California
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Los Angeles, California, États-Unis, 90033
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San Diego, California, États-Unis, 92103
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San Francisco, California, États-Unis, 94109
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Santa Monica, California, États-Unis, 90404
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Connecticut
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New Haven, Connecticut, États-Unis, 06510
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Florida
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Miami, Florida, États-Unis, 33137
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Tampa Bay, Florida, États-Unis, 33613
- 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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Mississippi
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Hattiesburg, Mississippi, États-Unis, 39401
- 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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Missouri
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Creve Coeur, Missouri, États-Unis, 63141
- 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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Kansas City, Missouri, États-Unis, 64114
- 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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New York
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Amherst, New York, États-Unis, 14226
- 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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Staten Island, New York, États-Unis, 10312
- 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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Oregon
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Portland, Oregon, États-Unis, 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, États-Unis, 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, États-Unis, 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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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
55 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Critère d'intégration:
- Répond aux critères de la maladie d'Alzheimer (MA) légère à modérée avec un score au mini-examen de l'état mental de 16 à 26 lors de la sélection
- Score sur l'échelle d'ischémie Hachinski modifiée inférieur ou égal à 4
- Score sur l'échelle de dépression gériatrique inférieur ou égal à 6
- Une imagerie par résonance magnétique (IRM) ou une tomodensitométrie (TDM) au cours des 2 dernières années sans résultats incompatibles avec un diagnostic de MA
- En cas de traitement concomitant contre la MA, doit prendre le médicament pendant au moins 4 mois à une dose stable pendant au moins 2 mois avant la randomisation
Critère d'exclusion:
- A une ou des maladie(s) grave(s) ou instable(s)
- N'a pas de soignant fiable qui est en contact fréquent avec le patient (au moins 10 heures par semaine)
- Répond aux critères du National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) pour la démence vasculaire
- N'a pas un bon accès veineux, de sorte que l'administration de médicaments par voie intraveineuse (IV) serait difficile
- A eu plusieurs épisodes de traumatisme crânien ou des antécédents au cours des 5 dernières années d'une maladie infectieuse grave affectant le cerveau
- A des allergies aux anticorps monoclonaux humanisés
- Abus chronique d'alcool et/ou de drogues au cours des 5 dernières années
- A des contre-indications pour les études IRM
- Nécessite un traitement avec un autre anticorps monoclonal
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur placebo: Placebo
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par voie intraveineuse (IV) toutes les 4 semaines pendant 80 semaines
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Expérimental: LY2062430
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400 mg par voie intraveineuse (IV) toutes les 4 semaines pendant 80 semaines
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Changement de la ligne de base à la semaine 80 dans l'échelle d'évaluation de la maladie d'Alzheimer - Cognitive Subscore 14-Item Scale (ADAS-Cog14)
Délai: Base de référence, semaine 80
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Base de référence, semaine 80
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Changement de la ligne de base à la semaine 80 dans l'évaluation clinique de la démence - score de la somme des cases (CDR-SB)
Délai: Base de référence, semaine 80
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Base de référence, semaine 80
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Changement de la ligne de base à la semaine 80 dans le score de l'inventaire neuropsychiatrique (NPI)
Délai: Base de référence, semaine 80
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Base de référence, semaine 80
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Changement de la ligne de base à la semaine 80 en imagerie par résonance magnétique volumétrique (vMRI)
Délai: Base de référence, semaine 80
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Base de référence, semaine 80
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Changement de la ligne de base à la semaine 80 du score du mini-examen de l'état mental (MMSE)
Délai: Base de référence, semaine 80
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Base de référence, semaine 80
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Changement de la ligne de base à la semaine 80 dans l'utilisation des ressources dans la démence - Score Lite (RUD-Lite)
Délai: Base de référence, semaine 80
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Base de référence, semaine 80
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Changement de la ligne de base à la semaine 80 du score de la version proxy de l'échelle de qualité de vie liée à la santé EuroQol 5-Dimensional (EQ-5D Proxy)
Délai: Base de référence, semaine 80
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Base de référence, semaine 80
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Changement du score de qualité de vie dans la maladie d'Alzheimer (QoL-AD) entre le départ et la semaine 80
Délai: Base de référence, semaine 80
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Base de référence, semaine 80
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Changement de la ligne de base à la semaine 80 dans les niveaux bêta d'amyloïde plasmatique
Délai: Base de référence, semaine 80
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Base de référence, semaine 80
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Changement de la ligne de base à la semaine 80 dans l'échelle d'évaluation de la maladie d'Alzheimer - Cognitive Subscore 11-Item and 12-Item Scale (ADAS-Cog11 et ADAS-Cog12)
Délai: Base de référence, semaine 80
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Base de référence, semaine 80
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Changement de la ligne de base à la semaine 80 dans l'étude coopérative sur la maladie d'Alzheimer - Score de l'inventaire des activités de la vie quotidienne (ADCS-ADL)
Délai: Base de référence, semaine 80
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Base de référence, semaine 80
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: 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
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mai 2009
Achèvement primaire (Réel)
1 juin 2012
Achèvement de l'étude (Réel)
1 juin 2012
Dates d'inscription aux études
Première soumission
18 mai 2009
Première soumission répondant aux critères de contrôle qualité
18 mai 2009
Première publication (Estimation)
20 mai 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
13 décembre 2012
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 décembre 2012
Dernière vérification
1 décembre 2012
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 11934
- H8A-MC-LZAN (Autre identifiant: Eli Lilly and Company)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .