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Effect of LY2062430 on the Progression of Alzheimer's Disease (EXPEDITION)

tiistai 18. syyskuuta 2012 päivittänyt: Eli Lilly and Company

Effect of LY2062430, an Anti-Amyloid Beta Monoclonal Antibody, on the Progression of Alzheimer's Disease as Compared With Placebo

Alzheimer's disease (AD) is an age-related degenerative disorder of the brain, characterized by progressive decline in cognitive function and ability to perform activities of daily living, and ultimately can lead to death due to complications of the disease. AD is thought to be caused by an excess of A-Beta amyloid, a sticky protein in the brain that forms amyloid plaques. Treatments that slow the synthesis or deposition of A-Beta amyloid, or that increase clearance, might be expected to slow the progression of AD.

LY2062430 (solanezumab) is a humanized anti-A Beta peptide immunoglobulin G-1 (IgG1) monoclonal antibody being developed for the treatment of AD. The primary hypothesis being tested is that LY2062430 will slow cognitive and functional decline in AD as compared with placebo. Each patient's participation will last approximately 19 months. Patients taking approved AD medications may participate in this study and continue taking these medications during the study.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Alzheimerin tauti

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Odotettu)

1000

Vaihe

Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

Argentiina
- - Buenos Aires, Argentiina, CBA 1419
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  - Cordoba, Argentiina, X5004AOA
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  - Mendoza, Argentiina, 5500
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  - Pueyrredon Cordoba, Argentiina, X5005ALB
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  - Rosario, Argentiina, S2000BZL
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  - Santa Fe, Argentiina, S3000FWO
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Brasilia
- - Curitiba, Brasilia, 81210-310
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  - Itapira, Brasilia, 13970-905
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  - Porto Alegre, Brasilia, 90110-270
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  - Rio De Janeiro, Brasilia, 20941-150
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  - São Paulo, Brasilia, 04024-002
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Japani
- - Aichi, Japani, 474-8511
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  - Fukuoka, Japani, 812-0033
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  - Hiroshima, Japani, 720-0825
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  - Kanagawa, Japani, 243-8550
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  - Kyoto, Japani, 607-8062
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  - Osaka, Japani, 567
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  - Shizuoka, Japani, 420-8688
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  - Tokyo, Japani, 187-8551
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Kanada
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- British Columbia
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  - Penticton, British Columbia, Kanada, V2A5C8
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- Ontario
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  - Toronto, Ontario, Kanada, M6M 3Z5
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- Quebec
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  - Sherbrooke, Quebec, Kanada, J1H1Z1
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Yhdysvallat
- Arizona
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  - Sun City, Arizona, Yhdysvallat, 85351
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  - Tuscon, Arizona, Yhdysvallat, 85718
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- Arkansas
  - Little Rock, Arkansas, Yhdysvallat, 72205
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- California
  - Carson, California, Yhdysvallat, 90746
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  - Irvine, California, Yhdysvallat, 92697
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  - Laguna Hills, California, Yhdysvallat, 92653
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  - Lomita, California, Yhdysvallat, 90717
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  - Orange, California, Yhdysvallat, 92868
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  - Oxnard, California, Yhdysvallat, 93030
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  - Santa Ana, California, Yhdysvallat, 92705
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- Colorado
  - Denver, Colorado, Yhdysvallat, 80239
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- Connecticut
  - Fairfield, Connecticut, Yhdysvallat, 06824
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  - Hamden, Connecticut, Yhdysvallat, 06518
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  - New Haven, Connecticut, Yhdysvallat, 06510
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  - Norwalk, Connecticut, Yhdysvallat, 06851
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- Delaware
  - Newark, Delaware, Yhdysvallat, 19713
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- District of Columbia
  - Washington, District of Columbia, Yhdysvallat, 20007
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- Florida
  - Boca Raton, Florida, Yhdysvallat, 33431
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  - Fort Myers, Florida, Yhdysvallat, 33912
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  - Hollywood, Florida, Yhdysvallat, 33021
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  - Miami Springs, Florida, Yhdysvallat, 33166
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  - North Miami, Florida, Yhdysvallat, 33161
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  - Orange City, Florida, Yhdysvallat, 32763
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  - Orlando, Florida, Yhdysvallat, 32806
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  - Sunrise, Florida, Yhdysvallat, 33351
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  - Tampa, Florida, Yhdysvallat, 33613
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- Georgia
  - Atlanta, Georgia, Yhdysvallat, 30341
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  - Canton, Georgia, Yhdysvallat, 30114
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  - Decatur, Georgia, Yhdysvallat, 30033
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- Indiana
  - Indianapolis, Indiana, Yhdysvallat, 46202
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- Kentucky
  - Lexington, Kentucky, Yhdysvallat, 40503
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- Maryland
  - Baltimore, Maryland, Yhdysvallat, 21285
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  - Rockville, Maryland, Yhdysvallat, 20852
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- Massachusetts
  - Belmont, Massachusetts, Yhdysvallat, 02478
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- Michigan
  - Grand Rapids, Michigan, Yhdysvallat, 49525
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  - Traverse City, Michigan, Yhdysvallat, 49684
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- New Mexico
  - Albuquerque, New Mexico, Yhdysvallat, 87109
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- New York
  - Albany, New York, Yhdysvallat, 12205
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  - Bronx, New York, Yhdysvallat, 10454
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  - Latham, New York, Yhdysvallat, 12210
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  - New York, New York, Yhdysvallat, 10032
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  - Orangeburg, New York, Yhdysvallat, 10962
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- North Carolina
  - Raleigh, North Carolina, Yhdysvallat, 27607
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  - Winston-Salem, North Carolina, Yhdysvallat, 27103
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- Ohio
  - Beachwood, Ohio, Yhdysvallat, 44122
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  - Toledo, Ohio, Yhdysvallat, 43623
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- Oklahoma
  - Oklahoma City, Oklahoma, Yhdysvallat, 73116
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- Oregon
  - Eugene, Oregon, Yhdysvallat, 97401
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- Pennsylvania
  - Philadelphia, Pennsylvania, Yhdysvallat, 19104
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- Rhode Island
  - East Providence, Rhode Island, Yhdysvallat, 02914
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- South Carolina
  - Charleston, South Carolina, Yhdysvallat, 29425
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  - Greer, South Carolina, Yhdysvallat, 29651
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- South Dakota
  - Sioux Falls, South Dakota, Yhdysvallat, 57105
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- Utah
  - Salt Lake City, Utah, Yhdysvallat, 84108
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- Vermont
  - Bennington, Vermont, Yhdysvallat, 05201
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  - Burlington, Vermont, Yhdysvallat, 05401
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- Virginia
  - Norfolk, Virginia, Yhdysvallat, 23502
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  - Roanoke, Virginia, Yhdysvallat, 24018
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55 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Inclusion Criteria:

Meets criteria for mild to moderate Alzheimer's Disease (AD) with Mini-Mental State Examination score of 16 through 26 at screening
Modified Hachinski Ischemia Scale score of less than or equal to 4
Geriatric Depression Scale score of less than or equal to 6
A magnetic resonance imaging (MRI) or computerized tomography (CT) scan in the last 2 years with no findings inconsistent with a diagnosis of AD
If receiving concurrent AD treatment, must be on the medication for at least 4 months at a stable dose for at least 2 months prior to randomization

Exclusion Criteria:

Has serious or unstable illness(es)
Does not have a reliable caregiver who is in frequent contact with patient (at least 10 hours per week)
Meets National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia
Does not have good venous access, such that intravenous (IV) drug delivery would be difficult
Has had multiple episodes of head trauma or history within the last 5 years of a serious infectious disease affecting the brain
Has allergies to humanized monoclonal antibodies
Chronic alcohol and/or drug abuse within the past 5 years
Has any contraindications for MRI studies
Requires treatment with another monoclonal antibody

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Ensisijainen käyttötarkoitus: Hoito
Jako: Satunnaistettu
Inventiomalli: Rinnakkaistehtävä
Naamiointi: Nelinkertaistaa

Aseiden lukumäärä

Aseet ja interventiot

Osallistujaryhmä / Arm	Interventio / Hoito
Placebo Comparator: Plasebo	Lääke: Plasebo suonensisäisesti (IV) 4 viikon välein 80 viikon ajan
Kokeellinen: LY2062430	Lääke: LY2062430 400 mg laskimoon (IV) 4 viikon välein 80 viikon ajan Muut nimet: Beta-vasta-aine Solanetsumabi (*USAN hyväksytty nimi, INN odottaa)

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus	Aikaikkuna
Change from baseline to endpoint in Alzheimer's Disease Assessment Scale-Cognitive subscore (ADAS-Cog11) Aikaikkuna: Baseline, 80 weeks	Baseline, 80 weeks
Change from baseline to endpoint in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL) Aikaikkuna: Baseline, 80 weeks	Baseline, 80 weeks

Toissijaiset tulostoimenpiteet

Tulosmittaus	Aikaikkuna
Change from baseline to endpoint in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Aikaikkuna: Baseline, 80 weeks	Baseline, 80 weeks
Change from baseline to endpoint in Neuropsychiatric Inventory (NPI) Aikaikkuna: Baseline, 80 weeks	Baseline, 80 weeks
Change from baseline to endpoint in volumetric magnetic resonance imaging (vMRI) Aikaikkuna: Baseline, 80 weeks	Baseline, 80 weeks
Change from baseline to endpoint in Mini-Mental State Examination (MMSE) Aikaikkuna: Baseline, 80 weeks	Baseline, 80 weeks
Change from baseline to endpoint in Resource Utilization in Dementia-Lite (RUD-Lite) Aikaikkuna: Baseline, 80 weeks	Baseline, 80 weeks
Change from baseline to endpoint in EuroQol 5-Dimensional Health-related Quality of Life Scale Proxy version (EQ-5D Proxy) Aikaikkuna: Baseline, 80 weeks	Baseline, 80 weeks
Change from baseline to endpoint in Quality of Life in Alzheimer's Disease (QoL-AD) Aikaikkuna: Baseline, 80 weeks	Baseline, 80 weeks
Change from baseline to endpoint in plasma LY2062430 to investigate a relationship between plasma LY2062430 and plasma A Beta levels. Aikaikkuna: Baseline, 80 weeks	Baseline, 80 weeks
Change from baseline to endpoint in plasma A Beta Aikaikkuna: Baseline, 80 weeks	Baseline, 80 weeks

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Eli Lilly and Company

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus

Perjantai 1. toukokuuta 2009

Ensisijainen valmistuminen (Todellinen)

Sunnuntai 1. huhtikuuta 2012

Opintojen valmistuminen (Todellinen)

Sunnuntai 1. huhtikuuta 2012

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Maanantai 18. toukokuuta 2009

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Maanantai 18. toukokuuta 2009

Ensimmäinen Lähetetty (Arvio)

Keskiviikko 20. toukokuuta 2009

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Arvio)

Tiistai 25. syyskuuta 2012

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Tiistai 18. syyskuuta 2012

Viimeksi vahvistettu

Tiistai 1. toukokuuta 2012

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

6747
H8A-MC-LZAM (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 .

Kliiniset tutkimukset LY2062430

Eli Lilly and Company

Valmis

Solanetsumabin turvallisuustutkimus japanilaisilla Alzheimerin tautia sairastavilla potilailla

Alzheimerin tauti

Japani
Eli Lilly and Company

Valmis

LY2062430:n vaikutukset potilailla, joilla on lievä tai keskivaikea Alzheimerin tauti, ja terveillä vapaaehtoisilla

Alzheimerin tauti

Yhdysvallat
Eli Lilly and Company
Alzheimer's Therapeutic Research Institute

Valmis

Solanetsumabin kliininen tutkimus iäkkäille henkilöille, jotka saattavat olla vaarassa muistin menetykselle (A4)

Kognitiohäiriöt

Yhdysvallat, Kanada, Australia, Japani
Eli Lilly and Company

Lopetettu

Continued Safety Monitoring of Solanezumab (LY2062430) in Alzheimer's Disease (EXPEDITION EXT)

Alzheimerin tauti

Yhdysvallat, Argentiina, Ranska, Japani, Kanada, Korean tasavalta, Australia, Brasilia, Espanja, Taiwan, Italia, Puola, Saksa, Venäjän federaatio, Yhdistynyt kuningaskunta, Ruotsi
Eli Lilly and Company

Lopetettu

Tutkimus LY2599666:sta terveillä osallistujilla ja osallistujilla, joilla on lievä kognitiivinen häiriö tai Alzheimerin tauti (AD)

Terve | Lievä kognitiivinen heikentyminen | Alzheimerin tauti

Yhdysvallat, Japani
Eli Lilly and Company

Lopetettu

A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease (ExpeditionPRO)

Alzheimerin tauti

Italia, Yhdysvallat, Espanja, Taiwan, Ranska, Japani, Puerto Rico, Puola, Ruotsi, Suomi, Kanada, Yhdistynyt kuningaskunta, Saksa
Eli Lilly and Company

Valmis

Biomarkkeritutkimus solanetsumabista potilailla, joilla on tai ei ole Alzheimerin tautia

Alzheimerin tauti

Yhdysvallat
Eli Lilly and Company

Lopetettu

Lievän Alzheimerin taudin eteneminen solanetsumabia saaneilla vs. lumelääkettä saaneilla (EXPEDITION 3)

Alzheimerin tauti

Yhdysvallat, Italia, Ranska, Japani, Australia, Saksa, Espanja, Ruotsi, Kanada, Puola, Yhdistynyt kuningaskunta
Eli Lilly and Company

Valmis

LY2062430:n vaikutus Alzheimerin taudin etenemiseen (EXPEDITION2)

Alzheimerin tauti

Espanja, Yhdysvallat, Ranska, Korean tasavalta, Japani, Australia, Taiwan, Ruotsi, Saksa, Italia, Puola, Venäjän federaatio, Yhdistynyt kuningaskunta
Washington University School of Medicine
Eli Lilly and Company; Hoffmann-La Roche; Avid Radiopharmaceuticals; National... ja muut yhteistyökumppanit

Valmis

Dominantly Herited Alzheimer Network Trial: Mahdollisuus ehkäistä dementiaa. Tutkimus mahdollisista sairauksia modifioivista hoidoista henkilöillä, joilla on geneettisen mutaation aiheuttaman varhaisen alkaneen Alzheimerin taudin riski tai jolla on sellainen varhainen sairaus. (DIAN-TU)

Dementia | Alzheimerin tauti | Alzheimerin tauti, perhe

Yhdysvallat, Kanada, Ranska, Espanja, Irlanti, Australia, Puerto Rico, Yhdistynyt kuningaskunta

Effect of LY2062430 on the Progression of Alzheimer's Disease (EXPEDITION)

Effect of LY2062430, an Anti-Amyloid Beta Monoclonal Antibody, on the Progression of Alzheimer's Disease as Compared With Placebo

Tutkimuksen yleiskatsaus

Tila

Ehdot

Interventio / Hoito

Opintotyyppi

Ilmoittautuminen (Odotettu)

Vaihe

Yhteystiedot ja paikat

Opiskelupaikat

Osallistumiskriteerit

Kelpoisuusvaatimukset

Opintokelpoiset iät

Hyväksyy terveitä vapaaehtoisia

Sukupuolet, jotka voivat opiskella

Kuvaus

Opintosuunnitelma

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Aseiden lukumäärä

Aseet ja interventiot

Osallistujaryhmä / Arm

Interventio / Hoito

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus

Aikaikkuna

Toissijaiset tulostoimenpiteet

Tulosmittaus

Aikaikkuna

Yhteistyökumppanit ja tutkijat

Sponsori

Julkaisuja ja hyödyllisiä linkkejä

Yleiset julkaisut

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

Kliiniset tutkimukset LY2062430

Hae vastaavia kokeiluja

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

CROs by country

CROs in Kenya

Ehdot

Harvinaiset sairaudet

Huumeiden interventiot

Ravintolisät

Sponsori / yhteistyökumppanit

Sijainnit