Effect of LY2062430 on the Progression of Alzheimer's Disease (EXPEDITION)
18. september 2012 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
1000
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
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, Brasil, 81210-310
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Itapira, Brasil, 13970-905
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Porto Alegre, Brasil, 90110-270
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Rio De Janeiro, Brasil, 20941-150
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São Paulo, Brasil, 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, Forente stater, 85006
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Sun City, Arizona, Forente stater, 85351
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Tuscon, Arizona, Forente stater, 85718
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Arkansas
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Little Rock, Arkansas, Forente stater, 72205
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California
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Carson, California, Forente stater, 90746
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Irvine, California, Forente stater, 92697
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Laguna Hills, California, Forente stater, 92653
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Lomita, California, Forente stater, 90717
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Orange, California, Forente stater, 92868
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Oxnard, California, Forente stater, 93030
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Santa Ana, California, Forente stater, 92705
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Colorado
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Denver, Colorado, Forente stater, 80239
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Connecticut
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Fairfield, Connecticut, Forente stater, 06824
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Hamden, Connecticut, Forente stater, 06518
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New Haven, Connecticut, Forente stater, 06510
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Norwalk, Connecticut, Forente stater, 06851
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Delaware
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Newark, Delaware, Forente stater, 19713
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District of Columbia
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Washington, District of Columbia, Forente stater, 20007
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Florida
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Boca Raton, Florida, Forente stater, 33431
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Fort Myers, Florida, Forente stater, 33912
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Hollywood, Florida, Forente stater, 33021
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Miami Springs, Florida, Forente stater, 33166
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North Miami, Florida, Forente stater, 33161
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Orange City, Florida, Forente stater, 32763
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Orlando, Florida, Forente stater, 32806
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Sunrise, Florida, Forente stater, 33351
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Tampa, Florida, Forente stater, 33613
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Georgia
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Atlanta, Georgia, Forente stater, 30341
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Canton, Georgia, Forente stater, 30114
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Decatur, Georgia, Forente stater, 30033
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Indiana
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Indianapolis, Indiana, Forente stater, 46202
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Kentucky
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Lexington, Kentucky, Forente stater, 40503
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Maryland
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Baltimore, Maryland, Forente stater, 21285
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Rockville, Maryland, Forente stater, 20852
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Massachusetts
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Belmont, Massachusetts, Forente stater, 02478
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Michigan
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Grand Rapids, Michigan, Forente stater, 49525
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Traverse City, Michigan, Forente stater, 49684
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87109
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New York
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Albany, New York, Forente stater, 12205
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Bronx, New York, Forente stater, 10454
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Latham, New York, Forente stater, 12210
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New York, New York, Forente stater, 10032
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Orangeburg, New York, Forente stater, 10962
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North Carolina
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Raleigh, North Carolina, Forente stater, 27607
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Winston-Salem, North Carolina, Forente stater, 27103
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Ohio
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Beachwood, Ohio, Forente stater, 44122
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Toledo, Ohio, Forente stater, 43623
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73116
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Oregon
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Eugene, Oregon, Forente stater, 97401
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
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Rhode Island
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East Providence, Rhode Island, Forente stater, 02914
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South Carolina
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Charleston, South Carolina, Forente stater, 29425
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Greer, South Carolina, Forente stater, 29651
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South Dakota
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Sioux Falls, South Dakota, Forente stater, 57105
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Utah
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Salt Lake City, Utah, Forente stater, 84108
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Vermont
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Bennington, Vermont, Forente stater, 05201
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Burlington, Vermont, Forente stater, 05401
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Virginia
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Norfolk, Virginia, Forente stater, 23502
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Roanoke, Virginia, Forente 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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
55 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: Placebo
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intravenøst (IV) hver 4. uke i 80 uker
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Eksperimentell: LY2062430
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400 mg intravenøst (IV) hver 4. uke i 80 uker
Andre navn:
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Hva måler studien?
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2009
Primær fullføring (Faktiske)
1. april 2012
Studiet fullført (Faktiske)
1. april 2012
Datoer for studieregistrering
Først innsendt
18. mai 2009
Først innsendt som oppfylte QC-kriteriene
18. mai 2009
Først lagt ut (Anslag)
20. mai 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
25. september 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. september 2012
Sist bekreftet
1. mai 2012
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 6747
- H8A-MC-LZAM (Annen identifikator: Eli Lilly and Company)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .