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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00905372

First received: May 18, 2009

Last updated: September 18, 2012

Last verified: May 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: LY2062430 Drug: Placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effect of LY2062430, an Anti-Amyloid Beta Monoclonal Antibody, on the Progression of Alzheimer's Disease as Compared With Placebo

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Change from baseline to endpoint in Alzheimer's Disease Assessment Scale—Cognitive subscore (ADAS-Cog11) [ Time Frame: Baseline, 80 weeks ] [ Designated as safety issue: No ]
Change from baseline to endpoint in Alzheimer's Disease Cooperative Study—Activities of Daily Living Inventory (ADCS-ADL) [ Time Frame: Baseline, 80 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline to endpoint in Clinical Dementia Rating—Sum of Boxes (CDR-SB) [ Time Frame: Baseline, 80 weeks ] [ Designated as safety issue: No ]
Change from baseline to endpoint in Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, 80 weeks ] [ Designated as safety issue: No ]
Change from baseline to endpoint in volumetric magnetic resonance imaging (vMRI) [ Time Frame: Baseline, 80 weeks ] [ Designated as safety issue: No ]
Change from baseline to endpoint in Mini-Mental State Examination (MMSE) [ Time Frame: Baseline, 80 weeks ] [ Designated as safety issue: No ]
Change from baseline to endpoint in Resource Utilization in Dementia—Lite (RUD-Lite) [ Time Frame: Baseline, 80 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Change from baseline to endpoint in Quality of Life in Alzheimer's Disease (QoL-AD) [ Time Frame: Baseline, 80 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Change from baseline to endpoint in plasma A Beta [ Time Frame: Baseline, 80 weeks ] [ Designated as safety issue: No ]


Estimated Enrollment:	1000
Study Start Date:	May 2009
Study Completion Date:	April 2012
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)
Placebo Comparator: Placebo	Drug: Placebo intravenously (IV) every 4 weeks for 80 weeks

Eligibility


Ages Eligible for Study:	55 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905372

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Locations


United States, 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
United States, Arkansas
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Little Rock, Arkansas, United States, 72205
United States, 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
United States, Colorado
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Denver, Colorado, United States, 80239
United States, 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
United States, Delaware
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Newark, Delaware, United States, 19713
United States, District of Columbia
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Washington, District of Columbia, United States, 20007
United States, 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
United States, 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
United States, Indiana
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Indianapolis, Indiana, United States, 46202
United States, Kentucky
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Lexington, Kentucky, United States, 40503
United States, Maryland
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Baltimore, Maryland, United States, 21285
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Rockville, Maryland, United States, 20852
United States, Massachusetts
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Belmont, Massachusetts, United States, 02478
United States, Michigan
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Grand Rapids, Michigan, United States, 49525
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Traverse City, Michigan, United States, 49684
United States, New Mexico
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Albuquerque, New Mexico, United States, 87109
United States, 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
United States, North Carolina
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Raleigh, North Carolina, United States, 27607
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Winston-Salem, North Carolina, United States, 27103
United States, Ohio
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Beachwood, Ohio, United States, 44122
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Toledo, Ohio, United States, 43623
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73116
United States, Oregon
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Eugene, Oregon, United States, 97401
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
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East Providence, Rhode Island, United States, 02914
United States, South Carolina
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Charleston, South Carolina, United States, 29425
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Greer, South Carolina, United States, 29651
United States, South Dakota
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Sioux Falls, South Dakota, United States, 57105
United States, Utah
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Salt Lake City, Utah, United States, 84108
United States, Vermont
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Bennington, Vermont, United States, 05201
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Burlington, Vermont, United States, 05401
United States, Virginia
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Norfolk, Virginia, United States, 23502
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Roanoke, Virginia, United States, 24018
Argentina
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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
Brazil
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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
Canada, Alberta
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Medicine Hat, Alberta, Canada, T1B4E7
Canada, British Columbia
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Kelowna, British Columbia, Canada, V1Y3G8
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Penticton, British Columbia, Canada, V2A5C8
Canada, Ontario
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Ottawa, Ontario, Canada, K1N 5C8
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Toronto, Ontario, Canada, M6M 3Z5
Canada, Quebec
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Greenfield Park, Quebec, Canada, J4V 2J2
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Sherbrooke, Quebec, Canada, J1H1Z1
Japan
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Aichi, Japan, 474-8511
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Fukuoka, Japan, 812-0033
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.
Hiroshima, Japan, 720-0825
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.
Kanagawa, Japan, 243-8550
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.
Kyoto, Japan, 607-8062
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.
Osaka, Japan, 567
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.
Shizuoka, Japan, 420-8688
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.
Tokyo, Japan, 187-8551

Sponsors and Collaborators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.


Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00905372 History of Changes
Other Study ID Numbers:	6747 H8A-MC-LZAM
Study First Received:	May 18, 2009
Last Updated:	September 18, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies	Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Antibodies Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2016

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