- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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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, Brazil, 81210-310
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Itapira, Brazil, 13970-905
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Porto Alegre, Brazil, 90110-270
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Rio De Janeiro, Brazil, 20941-150
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São Paulo, Brazil, 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, 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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Arizona
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Phoenix, Arizona, United States, 85006
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Sun City, Arizona, United States, 85351
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Tuscon, Arizona, United States, 85718
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Arkansas
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Little Rock, Arkansas, United States, 72205
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California
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Carson, California, United States, 90746
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Irvine, California, United States, 92697
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Laguna Hills, California, United States, 92653
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Lomita, California, United States, 90717
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Orange, California, United States, 92868
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Oxnard, California, United States, 93030
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Santa Ana, California, United States, 92705
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Colorado
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Denver, Colorado, United States, 80239
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Connecticut
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Fairfield, Connecticut, United States, 06824
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Hamden, Connecticut, United States, 06518
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New Haven, Connecticut, United States, 06510
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Norwalk, Connecticut, United States, 06851
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Delaware
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Newark, Delaware, United States, 19713
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District of Columbia
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Washington, District of Columbia, United States, 20007
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Florida
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Boca Raton, Florida, United States, 33431
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Fort Myers, Florida, United States, 33912
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Hollywood, Florida, United States, 33021
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Miami Springs, Florida, United States, 33166
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North Miami, Florida, United States, 33161
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Orange City, Florida, United States, 32763
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Orlando, Florida, United States, 32806
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Sunrise, Florida, United States, 33351
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Tampa, Florida, United States, 33613
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Georgia
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Atlanta, Georgia, United States, 30341
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Canton, Georgia, United States, 30114
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Decatur, Georgia, United States, 30033
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Indiana
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Indianapolis, Indiana, United States, 46202
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Kentucky
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Lexington, Kentucky, United States, 40503
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Maryland
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Baltimore, Maryland, United States, 21285
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Rockville, Maryland, United States, 20852
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Massachusetts
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Belmont, Massachusetts, United States, 02478
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Michigan
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Grand Rapids, Michigan, United States, 49525
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Traverse City, Michigan, United States, 49684
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New Mexico
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Albuquerque, New Mexico, United States, 87109
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New York
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Albany, New York, United States, 12205
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Bronx, New York, United States, 10454
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Latham, New York, United States, 12210
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New York, New York, United States, 10032
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Orangeburg, New York, United States, 10962
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North Carolina
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Raleigh, North Carolina, United States, 27607
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Winston-Salem, North Carolina, United States, 27103
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Ohio
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Beachwood, Ohio, United States, 44122
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Toledo, Ohio, United States, 43623
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73116
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Oregon
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Eugene, Oregon, United States, 97401
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
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Rhode Island
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East Providence, Rhode Island, United States, 02914
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South Carolina
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Charleston, South Carolina, United States, 29425
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Greer, South Carolina, United States, 29651
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South Dakota
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Sioux Falls, South Dakota, United States, 57105
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Utah
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Salt Lake City, Utah, United States, 84108
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Vermont
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Bennington, Vermont, United States, 05201
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Burlington, Vermont, United States, 05401
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Virginia
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Norfolk, Virginia, United States, 23502
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Roanoke, Virginia, United States, 24018
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
intravenously (IV) every 4 weeks for 80 weeks
|
Experimental: LY2062430
|
400 mg intravenously (IV) every 4 weeks for 80 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline to endpoint in Alzheimer's Disease Assessment Scale-Cognitive subscore (ADAS-Cog11)
Time Frame: Baseline, 80 weeks
|
Baseline, 80 weeks
|
Change from baseline to endpoint in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL)
Time Frame: Baseline, 80 weeks
|
Baseline, 80 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline to endpoint in Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Time Frame: Baseline, 80 weeks
|
Baseline, 80 weeks
|
Change from baseline to endpoint in Neuropsychiatric Inventory (NPI)
Time Frame: Baseline, 80 weeks
|
Baseline, 80 weeks
|
Change from baseline to endpoint in volumetric magnetic resonance imaging (vMRI)
Time Frame: Baseline, 80 weeks
|
Baseline, 80 weeks
|
Change from baseline to endpoint in Mini-Mental State Examination (MMSE)
Time Frame: Baseline, 80 weeks
|
Baseline, 80 weeks
|
Change from baseline to endpoint in Resource Utilization in Dementia-Lite (RUD-Lite)
Time Frame: 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)
Time Frame: Baseline, 80 weeks
|
Baseline, 80 weeks
|
Change from baseline to endpoint in Quality of Life in Alzheimer's Disease (QoL-AD)
Time Frame: 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.
Time Frame: Baseline, 80 weeks
|
Baseline, 80 weeks
|
Change from baseline to endpoint in plasma A Beta
Time Frame: Baseline, 80 weeks
|
Baseline, 80 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6747
- H8A-MC-LZAM (Other Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Eli Lilly and CompanyTerminatedAlzheimer's DiseaseItaly, United States, Spain, Taiwan, France, Japan, Puerto Rico, Poland, Sweden, Finland, Canada, United Kingdom, Germany
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Eli Lilly and CompanyCompletedAlzheimer's DiseaseUnited States
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Eli Lilly and CompanyTerminatedAlzheimer's DiseaseUnited States, Italy, France, Japan, Australia, Germany, Spain, Sweden, Canada, Poland, United Kingdom
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Eli Lilly and CompanyCompletedAlzheimer's DiseaseSpain, United States, France, Korea, Republic of, Japan, Australia, Taiwan, Sweden, Germany, Italy, Poland, Russian Federation, United Kingdom
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