Effect of LY2062430 on the Progression of Alzheimer's Disease (EXPEDITION)
18. september 2012 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
1000
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Buenos Aires, Argentina, CBA 1419
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Cordoba, Argentina, X5004AOA
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Mendoza, Argentina, 5500
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Pueyrredon Cordoba, Argentina, X5005ALB
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Rosario, Argentina, S2000BZL
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Santa Fe, Argentina, S3000FWO
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Curitiba, Brasilien, 81210-310
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Itapira, Brasilien, 13970-905
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Porto Alegre, Brasilien, 90110-270
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Rio De Janeiro, Brasilien, 20941-150
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São Paulo, Brasilien, 04024-002
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Alberta
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Medicine Hat, Alberta, Canada, T1B4E7
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British Columbia
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Kelowna, British Columbia, Canada, V1Y3G8
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Penticton, British Columbia, Canada, V2A5C8
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Ontario
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Ottawa, Ontario, Canada, K1N 5C8
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Toronto, Ontario, Canada, M6M 3Z5
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Quebec
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Greenfield Park, Quebec, Canada, J4V 2J2
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Sherbrooke, Quebec, Canada, J1H1Z1
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Arizona
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Phoenix, Arizona, Forenede Stater, 85006
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Sun City, Arizona, Forenede Stater, 85351
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Tuscon, Arizona, Forenede Stater, 85718
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
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California
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Carson, California, Forenede Stater, 90746
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Irvine, California, Forenede Stater, 92697
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Laguna Hills, California, Forenede Stater, 92653
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Lomita, California, Forenede Stater, 90717
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Orange, California, Forenede Stater, 92868
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Oxnard, California, Forenede Stater, 93030
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Santa Ana, California, Forenede Stater, 92705
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Colorado
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Denver, Colorado, Forenede Stater, 80239
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Connecticut
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Fairfield, Connecticut, Forenede Stater, 06824
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Hamden, Connecticut, Forenede Stater, 06518
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New Haven, Connecticut, Forenede Stater, 06510
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Norwalk, Connecticut, Forenede Stater, 06851
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Delaware
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Newark, Delaware, Forenede Stater, 19713
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20007
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Florida
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Boca Raton, Florida, Forenede Stater, 33431
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Fort Myers, Florida, Forenede Stater, 33912
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Hollywood, Florida, Forenede Stater, 33021
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Miami Springs, Florida, Forenede Stater, 33166
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North Miami, Florida, Forenede Stater, 33161
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Orange City, Florida, Forenede Stater, 32763
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Orlando, Florida, Forenede Stater, 32806
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Sunrise, Florida, Forenede Stater, 33351
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Tampa, Florida, Forenede Stater, 33613
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Georgia
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Atlanta, Georgia, Forenede Stater, 30341
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Canton, Georgia, Forenede Stater, 30114
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Decatur, Georgia, Forenede Stater, 30033
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40503
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Maryland
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Baltimore, Maryland, Forenede Stater, 21285
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Rockville, Maryland, Forenede Stater, 20852
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Massachusetts
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Belmont, Massachusetts, Forenede Stater, 02478
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Michigan
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Grand Rapids, Michigan, Forenede Stater, 49525
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Traverse City, Michigan, Forenede Stater, 49684
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87109
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New York
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Albany, New York, Forenede Stater, 12205
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Bronx, New York, Forenede Stater, 10454
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Latham, New York, Forenede Stater, 12210
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New York, New York, Forenede Stater, 10032
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Orangeburg, New York, Forenede Stater, 10962
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North Carolina
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Raleigh, North Carolina, Forenede Stater, 27607
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Winston-Salem, North Carolina, Forenede Stater, 27103
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Ohio
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Beachwood, Ohio, Forenede Stater, 44122
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Toledo, Ohio, Forenede Stater, 43623
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73116
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Oregon
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Eugene, Oregon, Forenede Stater, 97401
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
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Rhode Island
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East Providence, Rhode Island, Forenede Stater, 02914
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
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Greer, South Carolina, Forenede Stater, 29651
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South Dakota
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Sioux Falls, South Dakota, Forenede Stater, 57105
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Utah
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Salt Lake City, Utah, Forenede Stater, 84108
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Vermont
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Bennington, Vermont, Forenede Stater, 05201
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Burlington, Vermont, Forenede Stater, 05401
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Virginia
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Norfolk, Virginia, Forenede Stater, 23502
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Roanoke, Virginia, Forenede Stater, 24018
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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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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
55 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Placebo komparator: Placebo
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intravenøst (IV) hver 4. uge i 80 uger
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Eksperimentel: LY2062430
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400 mg intravenøst (IV) hver 4. uge i 80 uger
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change from baseline to endpoint in Alzheimer's Disease Assessment Scale-Cognitive subscore (ADAS-Cog11)
Tidsramme: Baseline, 80 weeks
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Baseline, 80 weeks
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Change from baseline to endpoint in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL)
Tidsramme: Baseline, 80 weeks
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Baseline, 80 weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change from baseline to endpoint in Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Tidsramme: Baseline, 80 weeks
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Baseline, 80 weeks
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Change from baseline to endpoint in Neuropsychiatric Inventory (NPI)
Tidsramme: Baseline, 80 weeks
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Baseline, 80 weeks
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Change from baseline to endpoint in volumetric magnetic resonance imaging (vMRI)
Tidsramme: Baseline, 80 weeks
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Baseline, 80 weeks
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Change from baseline to endpoint in Mini-Mental State Examination (MMSE)
Tidsramme: Baseline, 80 weeks
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Baseline, 80 weeks
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Change from baseline to endpoint in Resource Utilization in Dementia-Lite (RUD-Lite)
Tidsramme: Baseline, 80 weeks
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Baseline, 80 weeks
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Change from baseline to endpoint in EuroQol 5-Dimensional Health-related Quality of Life Scale Proxy version (EQ-5D Proxy)
Tidsramme: Baseline, 80 weeks
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Baseline, 80 weeks
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Change from baseline to endpoint in Quality of Life in Alzheimer's Disease (QoL-AD)
Tidsramme: Baseline, 80 weeks
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Baseline, 80 weeks
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Change from baseline to endpoint in plasma LY2062430 to investigate a relationship between plasma LY2062430 and plasma A Beta levels.
Tidsramme: Baseline, 80 weeks
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Baseline, 80 weeks
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Change from baseline to endpoint in plasma A Beta
Tidsramme: Baseline, 80 weeks
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Baseline, 80 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2009
Primær færdiggørelse (Faktiske)
1. april 2012
Studieafslutning (Faktiske)
1. april 2012
Datoer for studieregistrering
Først indsendt
18. maj 2009
Først indsendt, der opfyldte QC-kriterier
18. maj 2009
Først opslået (Skøn)
20. maj 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
25. september 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. september 2012
Sidst verificeret
1. maj 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 6747
- H8A-MC-LZAM (Anden identifikator: Eli Lilly and Company)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med LY2062430
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Eli Lilly and CompanyAfsluttetAlzheimers sygdomJapan
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Eli Lilly and CompanyAfsluttetAlzheimers sygdomForenede Stater
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Eli Lilly and CompanyAfsluttetAlzheimers sygdomForenede Stater, Argentina, Frankrig, Japan, Canada, Korea, Republikken, Australien, Brasilien, Spanien, Taiwan, Italien, Polen, Tyskland, Den Russiske Føderation, Det Forenede Kongerige, Sverige
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Eli Lilly and CompanyAlzheimer's Therapeutic Research InstituteAfsluttetKognitionsforstyrrelserForenede Stater, Canada, Australien, Japan
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Eli Lilly and CompanyAfsluttetSund og rask | Mild kognitiv svækkelse | Alzheimers sygdomForenede Stater, Japan
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Eli Lilly and CompanyAfsluttetAlzheimers sygdomItalien, Forenede Stater, Spanien, Taiwan, Frankrig, Japan, Puerto Rico, Polen, Sverige, Finland, Canada, Det Forenede Kongerige, Tyskland
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Eli Lilly and CompanyAfsluttetAlzheimers sygdomForenede Stater
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Eli Lilly and CompanyAfsluttetAlzheimers sygdomForenede Stater, Italien, Frankrig, Japan, Australien, Tyskland, Spanien, Sverige, Canada, Polen, Det Forenede Kongerige
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Eli Lilly and CompanyAfsluttetAlzheimers sygdomSpanien, Forenede Stater, Frankrig, Korea, Republikken, Japan, Australien, Taiwan, Sverige, Tyskland, Italien, Polen, Den Russiske Føderation, Det Forenede Kongerige
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Washington University School of MedicineEli Lilly and Company; Hoffmann-La Roche; Avid Radiopharmaceuticals; National... og andre samarbejdspartnereAfsluttetDemens | Alzheimers sygdom | Alzheimers sygdom, familiærForenede Stater, Canada, Frankrig, Spanien, Irland, Australien, Puerto Rico, Det Forenede Kongerige