- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00905372
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
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Buenos Aires, Argentine, CBA 1419
- 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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Cordoba, Argentine, X5004AOA
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Mendoza, Argentine, 5500
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Pueyrredon Cordoba, Argentine, X5005ALB
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Rosario, Argentine, S2000BZL
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Santa Fe, Argentine, S3000FWO
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Curitiba, Brésil, 81210-310
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Itapira, Brésil, 13970-905
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Porto Alegre, Brésil, 90110-270
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Rio De Janeiro, Brésil, 20941-150
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São Paulo, Brésil, 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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Aichi, Japon, 474-8511
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Fukuoka, Japon, 812-0033
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Hiroshima, Japon, 720-0825
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Kanagawa, Japon, 243-8550
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Kyoto, Japon, 607-8062
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Osaka, Japon, 567
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Shizuoka, Japon, 420-8688
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Tokyo, Japon, 187-8551
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Arizona
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Phoenix, Arizona, États-Unis, 85006
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Sun City, Arizona, États-Unis, 85351
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Tuscon, Arizona, États-Unis, 85718
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Arkansas
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Little Rock, Arkansas, États-Unis, 72205
- 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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California
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Carson, California, États-Unis, 90746
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Irvine, California, États-Unis, 92697
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Laguna Hills, California, États-Unis, 92653
- 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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Lomita, California, États-Unis, 90717
- 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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Orange, California, États-Unis, 92868
- 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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Oxnard, California, États-Unis, 93030
- 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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Santa Ana, California, États-Unis, 92705
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Colorado
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Denver, Colorado, États-Unis, 80239
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Connecticut
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Fairfield, Connecticut, États-Unis, 06824
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Hamden, Connecticut, États-Unis, 06518
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New Haven, Connecticut, États-Unis, 06510
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Norwalk, Connecticut, États-Unis, 06851
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Delaware
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Newark, Delaware, États-Unis, 19713
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District of Columbia
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Washington, District of Columbia, États-Unis, 20007
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Florida
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Boca Raton, Florida, États-Unis, 33431
- 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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Fort Myers, Florida, États-Unis, 33912
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Hollywood, Florida, États-Unis, 33021
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Miami Springs, Florida, États-Unis, 33166
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North Miami, Florida, États-Unis, 33161
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Orange City, Florida, États-Unis, 32763
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Orlando, Florida, États-Unis, 32806
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Sunrise, Florida, États-Unis, 33351
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Tampa, Florida, États-Unis, 33613
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Georgia
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Atlanta, Georgia, États-Unis, 30341
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Canton, Georgia, États-Unis, 30114
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Decatur, Georgia, États-Unis, 30033
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Indiana
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Indianapolis, Indiana, États-Unis, 46202
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Kentucky
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Lexington, Kentucky, États-Unis, 40503
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Maryland
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Baltimore, Maryland, États-Unis, 21285
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Rockville, Maryland, États-Unis, 20852
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Massachusetts
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Belmont, Massachusetts, États-Unis, 02478
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Michigan
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Grand Rapids, Michigan, États-Unis, 49525
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Traverse City, Michigan, États-Unis, 49684
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New Mexico
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Albuquerque, New Mexico, États-Unis, 87109
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New York
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Albany, New York, États-Unis, 12205
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Bronx, New York, États-Unis, 10454
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Latham, New York, États-Unis, 12210
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New York, New York, États-Unis, 10032
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Orangeburg, New York, États-Unis, 10962
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North Carolina
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Raleigh, North Carolina, États-Unis, 27607
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Winston-Salem, North Carolina, États-Unis, 27103
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Ohio
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Beachwood, Ohio, États-Unis, 44122
- 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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Toledo, Ohio, États-Unis, 43623
- 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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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73116
- 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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Eugene, Oregon, États-Unis, 97401
- 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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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- 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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Rhode Island
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East Providence, Rhode Island, États-Unis, 02914
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South Carolina
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Charleston, South Carolina, États-Unis, 29425
- 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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Greer, South Carolina, États-Unis, 29651
- 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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South Dakota
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Sioux Falls, South Dakota, États-Unis, 57105
- 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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Utah
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Salt Lake City, Utah, États-Unis, 84108
- 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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Vermont
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Bennington, Vermont, États-Unis, 05201
- 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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Burlington, Vermont, États-Unis, 05401
- 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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Virginia
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Norfolk, Virginia, États-Unis, 23502
- 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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Roanoke, Virginia, États-Unis, 24018
- 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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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur placebo: Placebo
|
par voie intraveineuse (IV) toutes les 4 semaines pendant 80 semaines
|
Expérimental: LY2062430
|
400 mg par voie intraveineuse (IV) toutes les 4 semaines pendant 80 semaines
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Change from baseline to endpoint in Alzheimer's Disease Assessment Scale-Cognitive subscore (ADAS-Cog11)
Délai: Baseline, 80 weeks
|
Baseline, 80 weeks
|
Change from baseline to endpoint in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL)
Délai: Baseline, 80 weeks
|
Baseline, 80 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Change from baseline to endpoint in Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Délai: Baseline, 80 weeks
|
Baseline, 80 weeks
|
Change from baseline to endpoint in Neuropsychiatric Inventory (NPI)
Délai: Baseline, 80 weeks
|
Baseline, 80 weeks
|
Change from baseline to endpoint in volumetric magnetic resonance imaging (vMRI)
Délai: Baseline, 80 weeks
|
Baseline, 80 weeks
|
Change from baseline to endpoint in Mini-Mental State Examination (MMSE)
Délai: Baseline, 80 weeks
|
Baseline, 80 weeks
|
Change from baseline to endpoint in Resource Utilization in Dementia-Lite (RUD-Lite)
Délai: 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)
Délai: Baseline, 80 weeks
|
Baseline, 80 weeks
|
Change from baseline to endpoint in Quality of Life in Alzheimer's Disease (QoL-AD)
Délai: 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.
Délai: Baseline, 80 weeks
|
Baseline, 80 weeks
|
Change from baseline to endpoint in plasma A Beta
Délai: Baseline, 80 weeks
|
Baseline, 80 weeks
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 6747
- H8A-MC-LZAM (Autre identifiant: Eli Lilly and Company)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur LY2062430
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Eli Lilly and CompanyComplétéLa maladie d'AlzheimerJapon
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Eli Lilly and CompanyComplétéLa maladie d'AlzheimerÉtats-Unis
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Eli Lilly and CompanyAlzheimer's Therapeutic Research InstituteComplétéTroubles cognitifsÉtats-Unis, Canada, Australie, Japon
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Eli Lilly and CompanyRésiliéEn bonne santé | Déficience cognitive légère | La maladie d'AlzheimerÉtats-Unis, Japon
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Eli Lilly and CompanyRésiliéLa maladie d'AlzheimerÉtats-Unis, Argentine, France, Japon, Canada, Corée, République de, Australie, Brésil, Espagne, Taïwan, Italie, Pologne, Allemagne, Fédération Russe, Royaume-Uni, Suède
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Eli Lilly and CompanyRésiliéLa maladie d'AlzheimerItalie, États-Unis, Espagne, Taïwan, France, Japon, Porto Rico, Pologne, Suède, Finlande, Canada, Royaume-Uni, Allemagne
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Eli Lilly and CompanyComplétéLa maladie d'AlzheimerÉtats-Unis
-
Eli Lilly and CompanyRésiliéLa maladie d'AlzheimerÉtats-Unis, Italie, France, Japon, Australie, Allemagne, Espagne, Suède, Canada, Pologne, Royaume-Uni
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Eli Lilly and CompanyComplétéLa maladie d'AlzheimerEspagne, États-Unis, France, Corée, République de, Japon, Australie, Taïwan, Suède, Allemagne, Italie, Pologne, Fédération Russe, Royaume-Uni
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Washington University School of MedicineEli Lilly and Company; Hoffmann-La Roche; Avid Radiopharmaceuticals; National... et autres collaborateursComplétéDémence | La maladie d'Alzheimer | Maladie d'Alzheimer, familialeÉtats-Unis, Canada, France, Espagne, Irlande, Australie, Porto Rico, Royaume-Uni