- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT00904683
LY2062430:n vaikutus Alzheimerin taudin etenemiseen (EXPEDITION2)
Passiivisen immunisoinnin vaikutus Alzheimerin taudin etenemiseen: LY2062430 vs. lumelääke
Alzheimerin tauti (AD) on ikään liittyvä aivojen rappeuttava sairaus, jolle on tunnusomaista kognitiivisten toimintojen ja kyvyn suorittaa päivittäisiä toimintoja asteittainen heikkeneminen ja joka voi lopulta johtaa kuolemaan sairauden komplikaatioiden vuoksi. AD:n uskotaan johtuvan liiallisesta A-beeta-amyloidista, aivoissa olevasta tahmeasta proteiinista, joka muodostaa amyloidiplakkeja. Hoidot, jotka hidastavat A-beeta-amyloidin synteesiä tai kerrostumista tai lisäävät puhdistumaa, saattavat hidastaa AD:n etenemistä.
LY2062430 (solanetsumabi) on humanisoitu anti-A-beetapeptidi-immunoglobuliini G-1 (IgG1) monoklonaalinen vasta-aine, jota kehitetään AD:n hoitoon. Ensisijainen testattava hypoteesi on, että LY2062430 hidastaa AD:n kognitiivista ja toiminnallista heikkenemistä lumelääkkeeseen verrattuna. Jokaisen potilaan osallistuminen kestää noin 19 kuukautta. Potilaat, jotka käyttävät hyväksyttyjä AD-lääkkeitä, voivat osallistua tähän tutkimukseen ja jatkaa näiden lääkkeiden käyttöä tutkimuksen aikana.
Tutkimuksen yleiskatsaus
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Opiskelupaikat
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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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Barcelona, Espanja, 08014
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Getafe, Espanja, 28905
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Madrid, Espanja, 28034
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Plasencia, Espanja, 10600
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Terrassa, Espanja, 0821
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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, Japani, 791-0295
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Fukuoka, Japani, 816-0864
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Hyogo, Japani, 514-8507
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Kanagawa, Japani, 247-0072
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Kyoto, Japani, 606-0851
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Osaka, Japani, 558-0056
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Shizuoka, Japani, 424-0911
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Tokyo, Japani, 173
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Incheon, Korean tasavalta, 400-711
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Seongnam-Si, Korean tasavalta, 463-707
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Seoul, Korean tasavalta, 143-729
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Suwon, Korean tasavalta, 443-721
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Bialystok, Puola, 15-617
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Bydgoszcz, Puola, 85-796
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Gliwice, Puola, 44-100
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Katowice, Puola, 40-588
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Krakow, Puola, 31-530
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Lublin, Puola, 20-090
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Warsaw, Puola, 02-777
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Aix En Provence, Ranska, 13100
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Paris, Ranska, 75475
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Rennes, Ranska, 35000
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Strasbourg, Ranska, 67091
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Toulouse, Ranska, 31300
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Joenkoeping, Ruotsi, 551 85
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Kalmar, Ruotsi, 39185
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Lund, Ruotsi, 22241
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Malmo, Ruotsi, 20502
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Molndal, Ruotsi, 43135
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Stockholm, Ruotsi, 14186
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Umea, Ruotsi, 901 85
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Berlin, Saksa, D-12200
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Hamburg, Saksa, 22307
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Hannover, Saksa, 30559
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Mannheim, Saksa, 68165
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Marburg, Saksa, 35033
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Munchen, Saksa, BY 80336
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München, Saksa, D-81675
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Regensburg, Saksa, 93042
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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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Chelyabinsk, Venäjän federaatio, 454091
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Ekaterinburg, Venäjän federaatio, 620030
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Rostov-On-Don, Venäjän federaatio, 344010
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Saint Petersburg, Venäjän federaatio, 190021
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E Susx
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Uckfield, E Susx, Yhdistynyt kuningaskunta, TN225AW
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Glasgow
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Scotland, Glasgow, Yhdistynyt kuningaskunta, G20 0XA
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Greater London
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London, Greater London, Yhdistynyt kuningaskunta, N195NX
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London
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Camberwell, London, Yhdistynyt kuningaskunta, SE5 8AF
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Syorks
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Sheffield, Syorks, Yhdistynyt kuningaskunta, S57JT
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Wiltshire
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Swindon, Wiltshire, Yhdistynyt kuningaskunta, SN3 6BW
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Arizona
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Tucson, Arizona, Yhdysvallat, 85741
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California
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Los Angeles, California, Yhdysvallat, 90033
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San Diego, California, Yhdysvallat, 92103
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San Francisco, California, Yhdysvallat, 94109
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Santa Monica, California, Yhdysvallat, 90404
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Connecticut
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New Haven, Connecticut, Yhdysvallat, 06510
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Florida
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Miami, Florida, Yhdysvallat, 33137
- 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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Tampa Bay, Florida, Yhdysvallat, 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, Yhdysvallat, 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, Yhdysvallat, 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, Yhdysvallat, 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, Yhdysvallat, 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, Yhdysvallat, 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, Yhdysvallat, 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, Yhdysvallat, 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, Yhdysvallat, 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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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Sisällyttämiskriteerit:
- Täyttää lievän tai keskivaikean Alzheimerin taudin (AD) kriteerit, ja seulontapisteet ovat 16-26.
- Muokatun Hachinskin iskemia-asteikon pistemäärä on pienempi tai yhtä suuri kuin 4
- Geriatric Depression Scale -pistemäärä on pienempi tai yhtä suuri kuin 6
- Magneettiresonanssikuvaus (MRI) tai tietokonetomografia (CT) viimeisen 2 vuoden aikana ilman AD-diagnoosin kanssa ristiriitaisia löydöksiä
- Jos saat samanaikaista AD-hoitoa, hänen on saatava lääkettä vähintään 4 kuukautta vakaalla annoksella vähintään 2 kuukautta ennen satunnaistamista
Poissulkemiskriteerit:
- hänellä on vakavia tai epävakaita sairauksia
- Hänellä ei ole luotettavaa hoitajaa, joka on usein yhteydessä potilaan kanssa (vähintään 10 tuntia viikossa)
- Täyttää National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) vaskulaarisen dementian kriteerit
- Sillä ei ole hyvää laskimopääsyä, joten suonensisäinen (IV) lääkkeen antaminen olisi vaikeaa
- hänellä on ollut useita päävamman jaksoja tai hänellä on ollut viimeisten 5 vuoden aikana vakava aivoihin vaikuttava infektiosairaus
- Hän on allerginen humanisoiduille monoklonaalisille vasta-aineille
- Krooninen alkoholin ja/tai huumeiden väärinkäyttö viimeisen viiden vuoden aikana
- Onko mitään vasta-aiheita MRI-tutkimuksiin
- Vaatii hoitoa toisella monoklonaalisella vasta-aineella
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Placebo Comparator: Plasebo
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suonensisäisesti (IV) 4 viikon välein 80 viikon ajan
|
Kokeellinen: LY2062430
|
400 mg laskimoon (IV) 4 viikon välein 80 viikon ajan
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
---|---|
Muutos lähtötilanteesta viikkoon 80 Alzheimerin taudin arviointiasteikossa – kognitiivinen alapistemäärä, 14-osainen asteikko (ADAS-Cog14)
Aikaikkuna: Perustaso, viikko 80
|
Perustaso, viikko 80
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
---|---|
Muutos perustilanteesta viikkoon 80 kliinisen dementian luokituksessa - Sum of Boxes (CDR-SB) -pisteet
Aikaikkuna: Perustaso, viikko 80
|
Perustaso, viikko 80
|
Neuropsychiatric Inventory (NPI) -pistemäärän muutos lähtötilanteesta viikkoon 80
Aikaikkuna: Perustaso, viikko 80
|
Perustaso, viikko 80
|
Muutos lähtötilanteesta viikkoon 80 volumetrisessä magneettikuvauksessa (vMRI)
Aikaikkuna: Perustaso, viikko 80
|
Perustaso, viikko 80
|
Muutos perustilanteesta viikkoon 80 Mini-Mental State Examination (MMSE) -pisteissä
Aikaikkuna: Perustaso, viikko 80
|
Perustaso, viikko 80
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Muutos perustilanteesta viikkoon 80 resurssien käytössä dementiassa - Lite (RUD-Lite) -pisteet
Aikaikkuna: Perustaso, viikko 80
|
Perustaso, viikko 80
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Muutos lähtötasosta viikolle 80 EuroQolin 5-ulotteisen terveyteen liittyvän elämänlaatuasteikon välityspalvelimen versiossa (EQ-5D-välityspalvelin)
Aikaikkuna: Perustaso, viikko 80
|
Perustaso, viikko 80
|
Alzheimerin taudin elämänlaadun (QoL-AD) pisteen muutos lähtötilanteesta viikkoon 80
Aikaikkuna: Perustaso, viikko 80
|
Perustaso, viikko 80
|
Plasman amyloidibeetatasojen muutos lähtötilanteesta viikkoon 80
Aikaikkuna: Perustaso, viikko 80
|
Perustaso, viikko 80
|
Muutos lähtötilanteesta viikkoon 80 Alzheimerin taudin arviointiasteikossa – kognitiivinen alapistemäärä 11 ja 12 kohta (ADAS-Cog11 ja ADAS-Cog12)
Aikaikkuna: Perustaso, viikko 80
|
Perustaso, viikko 80
|
Muutos lähtötilanteesta viikkoon 80 Alzheimerin taudin yhteistoiminnallisessa tutkimuksessa – Activities of Daily Living Inventory (ADCS-ADL) -pisteet
Aikaikkuna: Perustaso, viikko 80
|
Perustaso, viikko 80
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: 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
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 11934
- H8A-MC-LZAN (Muu tunniste: Eli Lilly and Company)
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
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