Effect of LY2062430 on the Progression of Alzheimer's Disease (EXPEDITION2)

Effect of Passive Immunization on the Progression of Alzheimer's Disease: LY2062430 Versus 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: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: LY2062430; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1040
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Bankstown, New South Wales, Australia, 2200
      • 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.
    • Darlinghurst, New South Wales, Australia, 2010
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    • Gosford, New South Wales, Australia, 2250
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    • Kogarah, New South Wales, Australia, 2217
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  • Queensland
    • Chermside, Queensland, Australia, 4032
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    • Toowoomba, Queensland, Australia, 4650
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  • Victoria
    • Box Hill, Victoria, Australia, 3128
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    • Glen Iris, Victoria, Australia, 3146
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    • Heidelberg Heights, Victoria, Australia, 3081
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    • Melbourne, Victoria, Australia, 3004
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  • Western Australia
    • Subiaco, Western Australia, Australia, 6008
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• France
  • Aix En Provence, France, 13100
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  • Paris, France, 75475
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  • Rennes, France, 35000
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  • Strasbourg, France, 67091
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  • Toulouse, France, 31300
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• Germany
  • Berlin, Germany, D-12200
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  • Hamburg, Germany, 22307
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  • Hannover, Germany, 30559
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  • Mannheim, Germany, 68165
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  • Marburg, Germany, 35033
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  • Munchen, Germany, BY 80336
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  • München, Germany, D-81675
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  • Regensburg, Germany, 93042
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• Italy
  • Biella, Italy, 13900
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  • Boggiovara, Italy, 41100
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  • Cassino, Italy, 03043
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  • Chieti, Italy, 66013
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  • Genova, Italy, 16128
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  • Lido Di Camaiore, Italy, 55043
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  • Milano, Italy, 20132
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  • Rome, Italy, 00179
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• Japan
  • Ehime, Japan, 791-0295
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  • Fukuoka, Japan, 816-0864
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  • Hyogo, Japan, 514-8507
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  • Kanagawa, Japan, 247-0072
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  • Kyoto, Japan, 606-0851
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  • Osaka, Japan, 558-0056
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  • Shizuoka, Japan, 424-0911
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  • Tokyo, Japan, 173
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• Korea, Republic of
  • Incheon, Korea, Republic of, 400-711
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  • Seongnam-Si, Korea, Republic of, 463-707
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  • Seoul, Korea, Republic of, 143-729
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  • Suwon, Korea, Republic of, 443-721
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• Poland
  • Bialystok, Poland, 15-617
    • 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.
  • Bydgoszcz, Poland, 85-796
    • 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.
  • Gliwice, Poland, 44-100
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  • Katowice, Poland, 40-588
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  • Krakow, Poland, 31-530
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  • Lublin, Poland, 20-090
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  • Warsaw, Poland, 02-777
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• Russian Federation
  • Chelyabinsk, Russian Federation, 454091
    • 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.
  • Ekaterinburg, Russian Federation, 620030
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  • Rostov-On-Don, Russian Federation, 344010
    • 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.
  • Saint Petersburg, Russian Federation, 190021
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• Spain
  • Barcelona, Spain, 08014
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  • Getafe, Spain, 28905
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  • Madrid, Spain, 28034
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  • Plasencia, Spain, 10600
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  • Terrassa, Spain, 0821
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• Sweden
  • Joenkoeping, Sweden, 551 85
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  • Kalmar, Sweden, 39185
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  • Lund, Sweden, 22241
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  • Malmo, Sweden, 20502
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  • Molndal, Sweden, 43135
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  • Stockholm, Sweden, 14186
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  • Umea, Sweden, 901 85
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• Taiwan
  • Kaohsiung, Taiwan, 807
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  • Niao Sung Hsiang, Taiwan, 83301
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  • Taichung, Taiwan, 404
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  • Taipei, Taiwan, 112
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  • Tao-Yuan, Taiwan, 333
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  • Yung-Kang, Tainan, Taiwan, 710
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• United Kingdom
  • E Susx
    • Uckfield, E Susx, United Kingdom, TN225AW
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  • Glasgow
    • Scotland, Glasgow, United Kingdom, G20 0XA
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  • Greater London
    • London, Greater London, United Kingdom, N195NX
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  • London
    • Camberwell, London, United Kingdom, SE5 8AF
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  • Syorks
    • Sheffield, Syorks, United Kingdom, S57JT
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  • Wiltshire
    • Swindon, Wiltshire, United Kingdom, SN3 6BW
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• United States
  • Arizona
    • Tucson, Arizona, United States, 85741
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  • California
    • Los Angeles, California, United States, 90033
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    • San Diego, California, United States, 92103
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    • San Francisco, California, United States, 94109
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    • Santa Monica, California, United States, 90404
      • 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.
  • Connecticut
    • New Haven, Connecticut, United States, 06510
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  • Florida
    • Miami, Florida, United States, 33137
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    • Tampa Bay, Florida, United States, 33613
      • 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.
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
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  • Missouri
    • Creve Coeur, Missouri, United States, 63141
      • 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.
    • Kansas City, Missouri, United States, 64114
      • 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.
  • New York
    • Amherst, New York, United States, 14226
      • 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.
    • Staten Island, New York, United States, 10312
      • 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.
  • Oregon
    • Portland, Oregon, United States, 97210
      • 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.
  • Texas
    • San Antonio, Texas, United States, 78229
      • 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.
  • Washington
    • Seattle, Washington, United States, 98108
      • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; intravenously (IV) every 4 weeks for 80 weeks
Experimental: LY2062430	Drug: LY2062430; 400 mg intravenously (IV) every 4 weeks for 80 weeks; Other Names: A Beta Antibody; Solanezumab (*USAN adopted name, INN pending)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline to Week 80 in Alzheimer's Disease Assessment Scale - Cognitive Subscore 14-Item Scale (ADAS-Cog14)	Baseline, Week 80

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline to Week 80 in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score	Baseline, Week 80
Change from Baseline to Week 80 in Neuropsychiatric Inventory (NPI) Score	Baseline, Week 80
Change from Baseline to Week 80 in volumetric Magnetic Resonance Imaging (vMRI)	Baseline, Week 80
Change from Baseline to Week 80 in Mini-Mental State Examination (MMSE) Score	Baseline, Week 80
Change from Baseline to Week 80 in Resource Utilization in Dementia - Lite (RUD-Lite) Score	Baseline, Week 80
Change from Baseline to Week 80 in EuroQol 5-Dimensional Health-related Quality of Life Scale Proxy version (EQ-5D Proxy) Score	Baseline, Week 80
Change from Baseline to Week 80 in Quality of Life in Alzheimer's Disease (QoL-AD) Score	Baseline, Week 80
Change from Baseline to Week 80 in Plasma Amyloid Beta Levels	Baseline, Week 80
Change from Baseline to Week 80 in Alzheimer's Disease Assessment Scale - Cognitive Subscore 11-Item and 12-Item Scale (ADAS-Cog11 and ADAS-Cog12)	Baseline, Week 80
Change from Baseline to Week 80 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) Score	Baseline, Week 80

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

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: May 1, 2009
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: May 18, 2009
• First Submitted That Met QC Criteria: May 18, 2009
• First Posted (Estimate): May 20, 2009

Study Record Updates

• Last Update Posted (Estimate): December 13, 2012
• Last Update Submitted That Met QC Criteria: December 11, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 11934; H8A-MC-LZAN (Other Identifier: Eli Lilly and Company)