Alzheimer's Disease Education and Referral Center

Progress of Mild Alzheimer's Disease with Solanezumab

Progress of Mild Alzheimer's Disease with Solanezumab

Overall Status: 
Recruiting
Brief Description: 

This Phase III study will test the drug solanezumab in older adults with mild Alzheimer's disease to determine if it can slow cognitive and functional decline.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
55 Years
90 Years
Both
No
Inclusion Criteria: 
    • Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's disease
    • Modified Hachinski Ischemia Scale score of less than or equal to 4
    • Mini-Mental State Examination score of 20 through 26 at screening visit
    • Geriatric Depression Scale score of less than or equal to 6
    • Results of a magnetic resonance imaging or computerized tomography scan within the past 2 years consistent with a diagnosis of Alzheimer's disease
    • Results of a florbetapir positron emission tomography scan or cerebrospinal fluid test consistent with the presence of amyloid pathology at screening
    • Reliable caregiver who is in frequent contact with the participant (at least 10 hours per week), can accompany participant to the office and/or be available by telephone at designated times, and monitor administration of prescribed medications
Exclusion Criteria: 
    • Meets National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia
    • Current serious or unstable illness, including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than Alzheimer's disease), psychiatric, immunologic, or hematologic disease; other conditions that could interfere with the study
    • Life expectancy of less than 2 years
    • History within the last 5 years of a serious infectious disease affecting the brain or head trauma resulting in protracted loss of consciousness
    • History within the last 5 years of a primary or recurrent malignant disease, with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen post-treatment
    • Known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions
    • Received acetylcholinesterase inhibitor, memantine, and/or other Alzheimer's therapy for less than 4 months or has less than 2 months of stable therapy on these treatments
    • Received medications that affect the central nervous system, except treatments for Alzheimer's, for less than 4 weeks
    • History of chronic alcohol or drug abuse/dependence within the past 5 years
Detailed Description: 

Participants will receive either the experimental drug, solanezumab (400 mg), or a placebo intravenously every 4 weeks for 18 months. Solanezumab is a monoclonal antibody that binds to the protein beta-amyloid, believed to be a key component of the harmful plaques that occur in the brains of people with Alzheimer's disease. Outcomes measures include changes in cognition, daily functioning, quality of life, and brain imaging results. Solanezumab has been tested in people with mild to moderate Alzheimer's disease.

Central Contact Information: 

For information about this study or study sites, please call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559, Monday through Friday, 9 a.m. to 5 p.m. Eastern time.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 33.4933743, -112.3579364

Site
Litchfield Park
Arizona
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 33.4483771, -112.0740373

Site
Phoenix
Arizona
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 33.5975393, -112.2718239

Site
Sun City
Arizona
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 32.2217429, -110.926479

Site
Tucson
Arizona
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 32.2217429, -110.926479

Site
Tuscon
Arizona
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 33.8314058, -118.2820165

Site
Carson
California
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 33.8702923, -117.925338

Site
Fullerton
California
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 33.6839473, -117.7946942

Site
Irvine
California
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 32.8328112, -117.2712717

Site
La Jolla
California
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 33.599722, -117.699444

Site
Laguna Hills
California
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 33.7922392, -118.3150722

Site
Lomita
California
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 33.7700504, -118.1937395

Site
Long Beach
California
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 34.0522342, -118.2436849

Site
Los Angeles
California
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 33.6189101, -117.9289469

Site
Newport Beach
California
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 34.1975048, -119.1770516

Site
Oxnard
California
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 34.0555693, -117.1825381

Site
Redlands
California
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 38.5815719, -121.4943996

Site
Sacramento
California
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 32.7153292, -117.1572551

Site
San Diego
California
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 37.7749295, -122.4194155

Site
San Francisco
California
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 33.7455731, -117.8678338

Site
Santa Ana
California
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 34.0194543, -118.4911912

Site
Santa Monica
California
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 38.4404674, -122.7144314

Site
Santa Rosa
California
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 34.1489719, -118.451357

Site
Sherman Oaks
California
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 39.737567, -104.9847179

Site
Denver
Colorado
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 41.1408363, -73.2612615

Site
Fairfield
Connecticut
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 41.3838782, -72.9026064

Site
Hamden
Connecticut
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 41.308274, -72.9278835

Site
New Haven
Connecticut
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 41.1175966, -73.4078968

Site
Norwalk
Connecticut
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 39.6837226, -75.7496572

Site
Newark
Delaware
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 38.9072309, -77.0364641

Site
Washington
District of Columbia
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 26.3683064, -80.1289321

Site
Boca Raton
Florida
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 26.3184123, -80.0997657

Site
Deerfield Beach
Florida
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 26.4614625, -80.0728201

Site
Delray Beach
Florida
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 26.640628, -81.8723084

Site
Fort Myers
Florida
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 25.9812024, -80.148379

Site
Hallandale Beach
Florida
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 26.0112014, -80.1494901

Site
Hollywood
Florida
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 30.3321838, -81.655651

Site
Jacksonville
Florida
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 25.7889689, -80.2264393

Site
Miami
Florida
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 25.8223198, -80.289495

Site
Miami Springs
Florida
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 29.1871986, -82.1400923

Site
Ocala
Florida
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 28.5383355, -81.3792365

Site
Orlando
Florida
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 26.1669711, -80.256595

Site
Sunrise
Florida
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 27.950575, -82.4571776

Site
Tampa
Florida
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 26.7153424, -80.0533746

Site
West Palm Beach
Florida
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 33.7489954, -84.3879824

Site
Atlanta
Georgia
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 41.8781136, -87.6297982

Site
Chicago
Illinois
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 42.0039178, -87.9703461

Site
Elk Grove Village
Illinois
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 39.768403, -86.158068

Site
Indianapolis
Indiana
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 39.114053, -94.6274636

Site
Kansas City
Kansas
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 39.1836082, -96.5716694

Site
Manhattan
Kansas
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 38.9916726, -94.6335684

Site
Prairie Village
Kansas
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 37.6888889, -97.3361111

Site
Wichita
Kansas
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 38.0405837, -84.5037164

Site
Lexington
Kentucky
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 29.9510658, -90.0715323

Site
New Orleans
Louisiana
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 32.5251516, -93.7501789

Site
Shreveport
Louisiana
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 44.0978509, -70.2311655

Site
Auburn
Maine
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 43.5901974, -70.3344921

Site
Scarborough
Maine
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 39.2903848, -76.6121893

Site
Baltimore
Maryland
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 42.3956405, -71.1776114

Site
Belmont
Massachusetts
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 42.3584308, -71.0597732

Site
Boston
Massachusetts
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 42.0834335, -71.0183787

Site
Brockton
Massachusetts
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 42.7262016, -71.1908924

Site
Methuen
Massachusetts
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 42.3370413, -71.2092214

Site
Newton
Massachusetts
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 44.7630567, -85.6206317

Site
Traverse City
Michigan
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 31.3271189, -89.2903392

Site
Hattiesburg
Mississippi
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 38.6270025, -90.1994042

Site
St Louis
Missouri
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 41.2523634, -95.9979883

Site
Omaha
Nebraska
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 36.1699412, -115.1398296

Site
Las Vegas
Nevada
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 40.3016375, -74.7361013

Site
Lawrenceville
New Jersey
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 35.110703, -106.609991

Site
Albuquerque
New Mexico
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 42.6525793, -73.7562317

Site
Albany
New York
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 42.9756133, -78.7914222

Site
Amherst
New York
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 40.65, -73.95

Site
Brooklyn
New York
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 40.7143528, -74.0059731

Site
New York
New York
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 40.5795317, -74.1502007

Site
Staten Island
New York
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 35.2270869, -80.8431267

Site
Charlotte
North Carolina
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 36.0726354, -79.7919754

Site
Greensboro
North Carolina
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 35.7795897, -78.6381787

Site
Raleigh
North Carolina
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 35.5465517, -77.0521742

Site
Washington
North Carolina
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 36.0998596, -80.244216

Site
Winston-Salem
North Carolina
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 39.6283928, -84.1593818

Site
Centerville
Ohio
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 39.9611755, -82.9987942

Site
Columbus
Ohio
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 39.7589478, -84.1916069

Site
Dayton
Ohio
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 41.4739419, -81.5370671

Site
Shaker Heights
Ohio
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 35.4675602, -97.5164276

Site
Oklahoma City
Oklahoma
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 44.5645659, -123.2620435

Site
Corvallis
Oregon
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 45.5234515, -122.6762071

Site
Portland
Oregon
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 40.6084305, -75.4901833

Site
Allentown
Pennsylvania
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 39.952335, -75.163789

Site
Philadelphia
Pennsylvania
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 40.4406248, -79.9958864

Site
Pittsburgh
Pennsylvania
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 41.8137116, -71.3700545

Site
East Providence
Rhode Island
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 41.8239891, -71.4128343

Site
Providence
Rhode Island
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 32.7765656, -79.9309216

Site
Charleston
South Carolina
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 34.9387279, -82.2270568

Site
Greer
South Carolina
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 43.5445959, -96.7311034

Site
Sioux Falls
South Dakota
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 36.3134397, -82.3534727

Site
Johnson City
Tennessee
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 36.1666667, -86.7833333

Site
Nashville
Tennessee
Recruiting
Name: Eli Lilly
Phone:
Lead Sponsor: 
Agency
Eli Lilly and Company
Collaborator Sponsor: 
Facility Investigators: 
RoleAffiliation
Study Director
Eli Lilly and Company
Study Contact: 
NamePhone
Eli Lilly
1-877-285-4559
Locations
 
 
ClinicalTrials.gov ID 
NCT01900665 (follow link to view full record on ct.gov in new window)
Official Title: 
Effect of Passive Immunization on the Progression of Mild Alzheimer's Disease: Solanezumab (LY2062430) Versus Placebo
Study Start Date: 
July 2013
Study End Date: 
December 2016
Disease Stage: 
Early
Enrollment: 
2100