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 33.4769572, -112.3592838

Site
Litchfield Park
Arizona
85351
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 33.4636012, -112.0535987

Site
Phoenix
Arizona
85006
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 33.612697, -112.280129

Site
Sun City
Arizona
85351
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 32.1701178, -110.9476831

Site
Tucson
Arizona
85714
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 32.3389931, -110.9268201

Site
Tuscon
Arizona
85718
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 33.8540061, -118.2585096

Site
Carson
California
90746
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 33.9041552, -117.9307584

Site
Fullerton
California
92835
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 33.6967044, -117.7743085

Site
Irvine
California
92607
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 32.8328112, -117.2712717

Site
La Jolla
California
92037
Not yet recruiting
Name: Eli Lilly
Phone:

Geolocation is 33.599722, -117.699444

Site
Laguna Hills
California
92653
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 33.7922392, -118.3150722

Site
Lomita
California
90717
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 33.7844997, -118.1971031

Site
Long Beach
California
90813
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 34.070264, -118.4440562

Site
Los Angeles
California
90095
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 33.615828, -117.9307584

Site
Newport Beach
California
92663
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 34.2054029, -119.1681373

Site
Oxnard
California
93030
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 34.0708773, -117.1558867

Site
Redlands
California
92374
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 38.5500434, -121.4599012

Site
Sacramento
California
95817
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 32.749789, -117.1676501

Site
San Diego
California
92103
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 37.7748363, -122.3872576

Site
San Francisco
California
94158
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 33.7455731, -117.8678338

Site
Santa Ana
California
92705
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 34.02875, -118.4717975

Site
Santa Monica
California
90404
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 38.4739555, -122.7520139

Site
Santa Rosa
California
95403
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 34.1423899, -118.4571974

Site
Sherman Oaks
California
91403
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 39.8086537, -104.8337879

Site
Denver
Colorado
80239
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 41.1948222, -73.28833

Site
Fairfield
Connecticut
06824
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 41.4305881, -72.9106202

Site
Hamden
Connecticut
06518
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 41.3065186, -72.9310714

Site
New Haven
Connecticut
06520
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 41.1339818, -73.4062342

Site
Norwalk
Connecticut
06851
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 39.6837226, -75.7496572

Site
Newark
Delaware
19713
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 38.9079086, -77.0716829

Site
Washington
District of Columbia
20057
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 26.3424842, -80.1149414

Site
Boca Raton
Florida
33486
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 26.2778269, -80.109357

Site
Deerfield Beach
Florida
33064
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 26.4460317, -80.1763467

Site
Delray Beach
Florida
33446
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 26.5273497, -81.8333656

Site
Fort Myers
Florida
33912
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 25.9812024, -80.148379

Site
Hallandale Beach
Florida
33009
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 26.0197012, -80.1819268

Site
Hollywood
Florida
33021
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 30.2606613, -81.460856

Site
Jacksonville
Florida
32224
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 25.7357116, -80.3992652

Site
Miami
Florida
33175
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 25.8223198, -80.289495

Site
Miami Springs
Florida
33166
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 29.1571921, -82.1223977

Site
Ocala
Florida
34471
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 28.5085825, -81.3564411

Site
Orlando
Florida
32806
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 26.17785, -80.2711588

Site
Sunrise
Florida
33351
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 28.0869646, -82.4698603

Site
Tampa
Florida
33613
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 26.7619563, -80.1037721

Site
West Palm Beach
Florida
33407
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 33.8992049, -84.3016021

Site
Atlanta
Georgia
30341
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 41.8816606, -87.6926257

Site
Chicago
Illinois
60612
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 42.0039178, -87.9703461

Site
Elk Grove Village
Illinois
60007
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 39.7794767, -86.1700894

Site
Indianapolis
Indiana
46202
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 39.06, -94.61

Site
Kansas City
Kansas
66160
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 39.1836082, -96.5716694

Site
Manhattan
Kansas
66502
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 38.9538595, -94.6192114

Site
Prairie Village
Kansas
66206
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 37.7040524, -97.3138554

Site
Wichita
Kansas
67214
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 38.0103355, -84.5327038

Site
Lexington
Kentucky
40503
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 29.9335739, -90.0326531

Site
New Orleans
Louisiana
70114
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 32.4850095, -93.7308152

Site
Shreveport
Louisiana
71104
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 44.0978509, -70.2311655

Site
Auburn
Maine
04210
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 43.6083314, -70.3976368

Site
Scarborough
Maine
04074
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 39.3996185, -76.6054535

Site
Baltimore
Maryland
21285
Recruiting
Name: Eli Lilly
Phone:

Geolocation is 42.3956405, -71.1776114

Site
Belmont
Massachusetts
02478
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