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

18 september 2012 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Verwacht)

1000

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

  • Argentinië
      • Buenos Aires, Argentinië, CBA 1419
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      • Cordoba, Argentinië, X5004AOA
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      • Mendoza, Argentinië, 5500
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      • Pueyrredon Cordoba, Argentinië, X5005ALB
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      • Rosario, Argentinië, S2000BZL
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      • Santa Fe, Argentinië, S3000FWO
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  • Brazilië
      • Curitiba, Brazilië, 81210-310
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      • Itapira, Brazilië, 13970-905
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      • Porto Alegre, Brazilië, 90110-270
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      • Rio De Janeiro, Brazilië, 20941-150
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      • São Paulo, Brazilië, 04024-002
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  • Canada
    • Alberta
      • Medicine Hat, Alberta, Canada, T1B4E7
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    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y3G8
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      • Penticton, British Columbia, Canada, V2A5C8
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    • Ontario
      • Ottawa, Ontario, Canada, K1N 5C8
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      • Toronto, Ontario, Canada, M6M 3Z5
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    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2J2
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      • Sherbrooke, Quebec, Canada, J1H1Z1
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  • Japan
      • Aichi, Japan, 474-8511
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      • Fukuoka, Japan, 812-0033
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      • Hiroshima, Japan, 720-0825
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      • Kanagawa, Japan, 243-8550
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      • Kyoto, Japan, 607-8062
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      • Osaka, Japan, 567
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      • Shizuoka, Japan, 420-8688
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      • Tokyo, Japan, 187-8551
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  • Verenigde Staten
    • Arizona
      • Phoenix, Arizona, Verenigde Staten, 85006
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      • Sun City, Arizona, Verenigde Staten, 85351
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      • Tuscon, Arizona, Verenigde Staten, 85718
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    • Arkansas
      • Little Rock, Arkansas, Verenigde Staten, 72205
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    • California
      • Carson, California, Verenigde Staten, 90746
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      • Irvine, California, Verenigde Staten, 92697
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      • Laguna Hills, California, Verenigde Staten, 92653
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      • Lomita, California, Verenigde Staten, 90717
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      • Orange, California, Verenigde Staten, 92868
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      • Oxnard, California, Verenigde Staten, 93030
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      • Santa Ana, California, Verenigde Staten, 92705
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    • Colorado
      • Denver, Colorado, Verenigde Staten, 80239
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    • Connecticut
      • Fairfield, Connecticut, Verenigde Staten, 06824
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      • Hamden, Connecticut, Verenigde Staten, 06518
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      • New Haven, Connecticut, Verenigde Staten, 06510
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      • Norwalk, Connecticut, Verenigde Staten, 06851
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    • Delaware
      • Newark, Delaware, Verenigde Staten, 19713
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    • District of Columbia
      • Washington, District of Columbia, Verenigde Staten, 20007
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    • Florida
      • Boca Raton, Florida, Verenigde Staten, 33431
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      • Fort Myers, Florida, Verenigde Staten, 33912
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      • Hollywood, Florida, Verenigde Staten, 33021
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      • Miami Springs, Florida, Verenigde Staten, 33166
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      • North Miami, Florida, Verenigde Staten, 33161
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      • Orange City, Florida, Verenigde Staten, 32763
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      • Orlando, Florida, Verenigde Staten, 32806
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      • Sunrise, Florida, Verenigde Staten, 33351
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      • Tampa, Florida, Verenigde Staten, 33613
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    • Georgia
      • Atlanta, Georgia, Verenigde Staten, 30341
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      • Canton, Georgia, Verenigde Staten, 30114
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      • Decatur, Georgia, Verenigde Staten, 30033
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    • Indiana
      • Indianapolis, Indiana, Verenigde Staten, 46202
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    • Kentucky
      • Lexington, Kentucky, Verenigde Staten, 40503
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    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21285
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      • Rockville, Maryland, Verenigde Staten, 20852
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    • Massachusetts
      • Belmont, Massachusetts, Verenigde Staten, 02478
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    • Michigan
      • Grand Rapids, Michigan, Verenigde Staten, 49525
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      • Traverse City, Michigan, Verenigde Staten, 49684
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    • New Mexico
      • Albuquerque, New Mexico, Verenigde Staten, 87109
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    • New York
      • Albany, New York, Verenigde Staten, 12205
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      • Bronx, New York, Verenigde Staten, 10454
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      • Latham, New York, Verenigde Staten, 12210
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      • New York, New York, Verenigde Staten, 10032
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      • Orangeburg, New York, Verenigde Staten, 10962
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    • North Carolina
      • Raleigh, North Carolina, Verenigde Staten, 27607
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      • Winston-Salem, North Carolina, Verenigde Staten, 27103
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    • Ohio
      • Beachwood, Ohio, Verenigde Staten, 44122
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      • Toledo, Ohio, Verenigde Staten, 43623
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    • Oklahoma
      • Oklahoma City, Oklahoma, Verenigde Staten, 73116
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    • Oregon
      • Eugene, Oregon, Verenigde Staten, 97401
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    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
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    • Rhode Island
      • East Providence, Rhode Island, Verenigde Staten, 02914
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    • South Carolina
      • Charleston, South Carolina, Verenigde Staten, 29425
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      • Greer, South Carolina, Verenigde Staten, 29651
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    • South Dakota
      • Sioux Falls, South Dakota, Verenigde Staten, 57105
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    • Utah
      • Salt Lake City, Utah, Verenigde Staten, 84108
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    • Vermont
      • Bennington, Vermont, Verenigde Staten, 05201
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      • Burlington, Vermont, Verenigde Staten, 05401
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    • Virginia
      • Norfolk, Virginia, Verenigde Staten, 23502
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      • Roanoke, Virginia, Verenigde Staten, 24018
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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

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

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
Placebo-vergelijker: Placebo
Geneesmiddel: Placebo
intraveneus (IV) elke 4 weken gedurende 80 weken
Experimenteel: LY2062430
Geneesmiddel: LY2062430
400 mg intraveneus (IV) elke 4 weken gedurende 80 weken
Andere namen:
  • Een bèta-antilichaam
  • Solanezumab (*USAN aangenomen naam, INN in afwachting)

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Change from baseline to endpoint in Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Tijdsspanne: Baseline, 80 weeks
Baseline, 80 weeks
Change from baseline to endpoint in Neuropsychiatric Inventory (NPI)
Tijdsspanne: Baseline, 80 weeks
Baseline, 80 weeks
Change from baseline to endpoint in volumetric magnetic resonance imaging (vMRI)
Tijdsspanne: Baseline, 80 weeks
Baseline, 80 weeks
Change from baseline to endpoint in Mini-Mental State Examination (MMSE)
Tijdsspanne: Baseline, 80 weeks
Baseline, 80 weeks
Change from baseline to endpoint in Resource Utilization in Dementia-Lite (RUD-Lite)
Tijdsspanne: 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)
Tijdsspanne: Baseline, 80 weeks
Baseline, 80 weeks
Change from baseline to endpoint in Quality of Life in Alzheimer's Disease (QoL-AD)
Tijdsspanne: 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.
Tijdsspanne: Baseline, 80 weeks
Baseline, 80 weeks
Change from baseline to endpoint in plasma A Beta
Tijdsspanne: Baseline, 80 weeks
Baseline, 80 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

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

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 april 2012

Studie voltooiing (Werkelijk)

1 april 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)

25 september 2012

Laatste update ingediend die voldeed aan QC-criteria

18 september 2012

Laatst geverifieerd

1 mei 2012

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 6747
  • H8A-MC-LZAM (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 .

Klinische onderzoeken op LY2062430

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Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

3
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