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 33.476676, -112.3596335

Site
Litchfield Park
Arizona
85351
Active, not recruiting
Name:
Phone:

Geolocation is 33.4528292, -112.0685027

Site
Phoenix
Arizona
85004
Recruiting
Name:
Phone: 602-274-9500

Geolocation is 33.5080943, -112.0863874

Site
Phoenix
Arizona
85013
Recruiting
Name:
Phone: 602-406-4032

Geolocation is 33.4636012, -112.0535987

Site
Phoenix
Arizona
85006
Recruiting
Name:
Phone: 602-839-6979

Geolocation is 33.6020658, -112.280129

Site
Sun City
Arizona
85351
Recruiting
Name:
Phone: 623-732-3800

Geolocation is 33.6020658, -112.280129

Site
Sun City
Arizona
85351
Recruiting
Name:
Phone: 623-832-6530

Geolocation is 32.3389931, -110.9268201

Site
Tucson
Arizona
85718
Recruiting
Name:
Phone: 520-320-2147

Geolocation is 32.2402988, -110.9454478

Site
Tuscon
Arizona
85724
Recruiting
Name:
Phone: 520-626-6524

Geolocation is 33.8540061, -118.2585096

Site
Carson
California
90746
Recruiting
Name:
Phone: 310-329-2170

Geolocation is 33.9041552, -117.9307584

Site
Fullerton
California
92835
Recruiting
Name:
Phone: 714-879-7200

Geolocation is 33.6471239, -117.8421325

Site
Irvine
California
92697
Recruiting
Name:
Phone: 949-824-2382

Geolocation is 32.8328112, -117.2712717

Site
La Jolla
California
92037
Recruiting
Name:
Phone: 858-246-1300

Geolocation is 33.599722, -117.699444

Site
Laguna Hills
California
92653
Recruiting
Name:
Phone: 949-588-0909

Geolocation is 33.7922392, -118.3150722

Site
Lomita
California
90717
Recruiting
Name:
Phone: 310-373-8120

Geolocation is 33.8065036, -118.1912538

Site
Long Beach
California
90806
Recruiting
Name:
Phone: 916-934-0569

Geolocation is 33.7844997, -118.1971031

Site
Long Beach
California
90813
Recruiting
Name:
Phone: 562-437-4780

Geolocation is 34.0502898, -118.2117257

Site
Los Angeles
California
90033
Recruiting
Name:
Phone: 323-442-7600

Geolocation is 34.0522561, -118.452087

Site
Los Angeles
California
90073
Recruiting
Name:
Phone: 310-268-3708

Geolocation is 34.070264, -118.4440562

Site
Los Angeles
California
90095
Recruiting
Name:
Phone: 310-794-3231

Geolocation is 33.615828, -117.9307584

Site
Newport Beach
California
92663
Recruiting
Name:
Phone: 949-478-8858

Geolocation is 34.2054029, -119.1681373

Site
Oxnard
California
93030
Recruiting
Name: Eli Lilly
Phone: 877-285-4559

Geolocation is 34.0708773, -117.1558867

Site
Redlands
California
92374
Recruiting
Name:
Phone: 909-792-9007

Geolocation is 38.5500434, -121.4599012

Site
Sacramento
California
95817
Recruiting
Name:
Phone: 916-734-5245

Geolocation is 32.749789, -117.1676501

Site
San Diego
California
92103
Recruiting
Name:
Phone: 619-294-4302

Geolocation is 32.8102534, -117.1323579

Site
San Diego
California
92123
Recruiting
Name:
Phone: 858-836-8350

Geolocation is 32.749789, -117.1676501

Site
San Diego
California
92103
Recruiting
Name:
Phone: 858-278-3647

Geolocation is 37.7929789, -122.4212424

Site
San Francisco
California
94109
Recruiting
Name:
Phone: 415-673-6400

Geolocation is 37.7748363, -122.3872576

Site
San Francisco
California
94158
Recruiting
Name:
Phone: 415-476-0661

Geolocation is 33.7455731, -117.8678338

Site
Santa Ana
California
92705
Recruiting
Name:
Phone: 714-542-3008

Geolocation is 38.4739555, -122.7520139

Site
Santa Rosa
California
95403
Recruiting
Name:
Phone: 707-521-3830

Geolocation is 34.1423899, -118.4571974

Site
Sherman Oaks
California
91403
Recruiting
Name:
Phone: 818-990-2671

Geolocation is 39.8086537, -104.8337879

Site
Denver
Colorado
80239
Recruiting
Name:
Phone: 303-477-1880

Geolocation is 41.1948222, -73.28833

Site
Fairfield
Connecticut
06824
Recruiting
Name:
Phone: 203-333-1151

Geolocation is 41.3052226, -72.9268626

Site
New Haven
Connecticut
06510
Recruiting
Name:
Phone: 203-401-4349

Geolocation is 41.3065186, -72.9310714

Site
New Haven
Connecticut
06520-8020
Recruiting
Name:
Phone: 203-764-8100

Geolocation is 41.1339818, -73.4062342

Site
Norwalk
Connecticut
06851
Recruiting
Name:
Phone: 203-838-0070

Geolocation is 39.6837226, -75.7496572

Site
Newark
Delaware
19713
Recruiting
Name:
Phone: 302-731-1301

Geolocation is 38.9079086, -77.0716829

Site
Washington
District of Columbia
20057
Recruiting
Name:
Phone: 202-687-7337

Geolocation is 26.3767589, -80.1037721

Site
Boca Raton
Florida
33431
Recruiting
Name:
Phone: 561-297-0164

Geolocation is 26.3424842, -80.1149414

Site
Boca Raton
Florida
33486
Active, not recruiting
Name:
Phone:

Geolocation is 26.2778269, -80.109357

Site
Deerfield Beach
Florida
33064
Recruiting
Name:
Phone: 954-786-7331

Geolocation is 26.4647478, -80.109357

Site
Delray Beach
Florida
33445
Recruiting
Name:
Phone: 561-374-8461

Geolocation is 26.4460317, -80.1763467

Site
Delray Beach
Florida
33446
Recruiting
Name:
Phone: 561-496-7200

Geolocation is 26.5273497, -81.8333656

Site
Fort Myers
Florida
33912
Recruiting
Name:
Phone: 239-939-9777

Geolocation is 25.9812024, -80.148379

Site
Hallandale Beach
Florida
33009
Recruiting
Name:
Phone: 954-455-5757

Geolocation is 26.0197012, -80.1819268

Site
Hollywood
Florida
33021
Recruiting
Name:
Phone: 954-981-3850

Geolocation is 30.2906907, -81.5706109

Site
Jacksonville
Florida
32216
Recruiting
Name:
Phone: 904-730-0101

Geolocation is 30.2606613, -81.460856

Site
Jacksonville
Florida
32224
Recruiting
Name:
Phone: 904-953-7103

Geolocation is 25.8207159, -80.1819268

Site
Miami
Florida
33137
Recruiting
Name:
Phone: 305-751-8626

Geolocation is 25.7357116, -80.3992652

Site
Miami
Florida
33175
Active, not recruiting
Name:
Phone:

Geolocation is 25.8223198, -80.289495

Site
Miami Springs
Florida
33166
Recruiting
Name:
Phone: 305-805-0921

Geolocation is 29.1571921, -82.1223977

Site
Ocala
Florida
34471
Recruiting
Name:
Phone: 352-629-5800

Geolocation is 28.5085825, -81.3564411

Site
Orlando
Florida
32806
Recruiting
Name:
Phone: 407-426-9299

Geolocation is 26.17785, -80.2711588

Site
Sunrise
Florida
33351-6637
Recruiting
Name:
Phone: 954-475-8171

Geolocation is 27.9407591, -82.5104655

Site
Tampa
Florida
33609
Recruiting
Name:
Phone: 813-353-9613

Geolocation is 28.0869646, -82.4698603

Site
Tampa
Florida
33613
Recruiting
Name:
Phone: 813-971-8311

Geolocation is 28.0869646, -82.4698603

Site
Tampa
Florida
33613
Recruiting
Name:
Phone: 813-974-4355

Geolocation is 26.7619563, -80.1037721

Site
West Palm Beach
Florida
33407
Recruiting
Name:
Phone: 561-845-0500

Geolocation is 33.7717008, -84.3726049

Site
Atlanta
Georgia
30308
Recruiting
Name:
Phone: 404-881-5800

Geolocation is 33.8992049, -84.3016021

Site
Atlanta
Georgia
30341
Active, not recruiting
Name:
Phone:

Geolocation is 41.8816606, -87.6926257

Site
Chicago
Illinois
60612
Recruiting
Name:
Phone: 312-942-2338

Geolocation is 42.0039178, -87.9703461

Site
Elk Grove Village
Illinois
60007
Recruiting
Name:
Phone: 847-593-8553

Geolocation is 39.7794767, -86.1700894

Site
Indianapolis
Indiana
46202
Recruiting
Name:
Phone: 317-963-4702

Geolocation is 39.06, -94.61

Site
Kansas City
Kansas
66160
Recruiting
Name:
Phone: 913-588-0555

Geolocation is 38.9538595, -94.6192114

Site
Prairie Village
Kansas
66206
Recruiting
Name:
Phone: 913-381-7180

Geolocation is 37.6614293, -97.2329255

Site
Wichita
Kansas
67207
Recruiting
Name:
Phone: 316-689-6629

Geolocation is 37.7040524, -97.3138554

Site
Wichita
Kansas
67214
Recruiting
Name:
Phone: 316-291-4774

Geolocation is 38.0103355, -84.5327038

Site
Lexington
Kentucky
40503
Recruiting
Name:
Phone: 859-260-4330

Geolocation is 29.9335739, -90.0326531

Site
New Orleans
Louisiana
70114
Active, not recruiting
Name:
Phone:

Geolocation is 32.4850095, -93.7308152

Site
Shreveport
Louisiana
71104
Recruiting
Name:
Phone: 318-277-9600

Geolocation is 44.0978509, -70.2311655

Site
Auburn
Maine
04210
Recruiting
Name:
Phone: 207-782-9835

Geolocation is 43.6083314, -70.3976368

Site
Scarborough
Maine
04074
Recruiting
Name:
Phone: 207-883-1414

Geolocation is 39.3744588, -76.745195

Site
Baltimore
Maryland
21208
Recruiting
Name:
Phone: 410-602-1440

Geolocation is 42.3956405, -71.1776114

Site
Belmont
Massachusetts
02478
Recruiting
Name:
Phone: 617-855-2532

Geolocation is 42.3377967, -71.0705763

Site
Boston
Massachusetts
02118
Recruiting
Name:
Phone: 617-638-5678

Geolocation is 42.339904, -71.0898892

Site
Boston
Massachusetts
02115
Recruiting
Name:
Phone: 617-732-8085

Geolocation is 42.0725522, -71.0378909

Site
Brockton
Massachusetts
02301
Recruiting
Name:
Phone: 774-462-6610

Geolocation is 42.7262016, -71.1908924

Site
Methuen
Massachusetts
01844
Recruiting
Name:
Phone: 978-655-7155

Geolocation is 42.3028239, -71.1864397

Site
Newton
Massachusetts
02459
Recruiting
Name:
Phone: 802-447-1409

Geolocation is 44.7630567, -85.6206317

Site
Traverse City
Michigan
49684
Recruiting
Name:
Phone: 231-935-0340

Geolocation is 31.3271189, -89.2903392

Site
Hattiesburg
Mississippi
39402
Recruiting
Name:
Phone: 601-579-5345

Geolocation is 38.5950619, -90.2291565

Site
St. Louis
Missouri
63118
Not yet recruiting
Name:
Phone: 314-771-6387

Geolocation is 41.2552541, -95.9796225

Site
Omaha
Nebraska
68198
Recruiting
Name:
Phone: 402-559-4496

Geolocation is 36.0563775, -115.2659777

Site
Las Vegas
Nevada
89113
Recruiting
Name:
Phone: 310-493-9118

Geolocation is 36.1922841, -115.1592718

Site
Las Vegas
Nevada
89106
Recruiting
Name:
Phone: 702-483-6026

Geolocation is 40.3016375, -74.7361013

Site
Lawrenceville
New Jersey
08648
Recruiting
Name:
Phone: 609-895-0735

Geolocation is 35.1590068, -106.5760857

Site
Albuquerque
New Mexico
87109
Recruiting
Name:
Phone: 505-848-3773

Geolocation is 42.6757698, -73.7860276

Site
Albany
New York
12206
Recruiting
Name:
Phone: 518-459-8106

Geolocation is 42.9674726, -78.7986181

Site
Amherst
New York
14226
Recruiting
Name:
Phone: 716-250-2000

Geolocation is 40.5860069, -73.9418603

Site
Brooklyn
New York
11235
Recruiting
Name:
Phone: 718-616-2400

Geolocation is 40.8409822, -73.9447994

Site
New York
New York
10032
Recruiting
Name:
Phone: 212-305-9194

Geolocation is 40.74727, -73.9800645

Site
New York
New York
10016
Recruiting
Name:
Phone: 212-263-3210

Geolocation is 40.7916407, -73.9447994

Site
New York
New York
10029-6574
Recruiting
Name:
Phone: 212-241-8329

Geolocation is 40.555548, -74.1827119

Site
Staten Island
New York
10312
Recruiting
Name:
Phone: 718-317-5522

Geolocation is 35.2146586, -80.8599193

Site
Charlotte
North Carolina
28203
Recruiting
Name:
Phone: 704-527-6672

Geolocation is 35.1660032, -80.7934798

Site
Charlotte
North Carolina
28211
Recruiting
Name:
Phone: 704-446-7504

Geolocation is 36.1155274, -79.7512033

Site
Greensboro
North Carolina
27405
Recruiting
Name:
Phone: 336-273-2511

Geolocation is 35.8533273, -78.6965972

Site
Raleigh
North Carolina
27612
Recruiting
Name:
Phone: 919-781-2514

Geolocation is 36.0564654, -80.3324514

Site
Winston-Salem
North Carolina
27103
Recruiting
Name:
Phone: 336-768-8062

Geolocation is 39.6400784, -84.1751648

Site
Centerville
Ohio
45459
Recruiting
Name:
Phone: 937-208-8298

Geolocation is 39.9990626, -83.0173386

Site
Columbus
Ohio
43210
Recruiting
Name:
Phone: 614-293-4969

Geolocation is 39.7383713, -84.2910759

Site
Dayton
Ohio
45417
Recruiting
Name:
Phone: 937-495-0000

Geolocation is 41.4739419, -81.5370671

Site
Shaker Heights
Ohio
44122
Recruiting
Name:
Phone: 216-526-1843

Geolocation is 35.5424793, -97.5518056

Site
Oklahoma City
Oklahoma
73116
Recruiting
Name:
Phone: 405-603-8068

Geolocation is 35.5135639, -97.5788975

Site
Oklahoma City
Oklahoma
73112
Recruiting
Name:
Phone: 405-759-5600

Geolocation is 44.5645659, -123.2620435

Site
Corvallis
Oregon
97330
Recruiting
Name:
Phone: 541-754-1274

Geolocation is 45.5478224, -122.7288206

Site
Portland
Oregon
97210
Recruiting
Name:
Phone: 503-279-8252

Geolocation is 40.6084305, -75.4901833

Site
Allentown
Pennsylvania
18104
Not yet recruiting
Name:
Phone: 610-820-0342

Geolocation is 39.9556241, -75.1647529

Site
Philadelphia
Pennsylvania
19102
Recruiting
Name:
Phone: 215-762-7090

Geolocation is 40.4379259, -79.9556424

Site
Pittsburgh
Pennsylvania
15213
Recruiting
Name:
Phone: 412-692-2700

Geolocation is 41.8164902, -71.3646236

Site
East Providence
Rhode Island
02914
Recruiting
Name:
Phone: 401-435-8950

Geolocation is 41.8396817, -71.3883751

Site
Providence
Rhode Island
02906
Recruiting
Name:
Phone: 401-455-6403

Geolocation is 41.816736, -71.4091563

Site
Providence
Rhode Island
02903
Recruiting
Name:
Phone: 401-444-6440

Geolocation is 32.7791432, -79.9248669

Site
Charleston
South Carolina
29401
Recruiting
Name:
Phone: 843-724-2302

Geolocation is 34.9387279, -82.2270568

Site
Greer
South Carolina
29651
Recruiting
Name:
Phone: 864-877-9239
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