Donanemab for the Prevention of Alzheimer's Disease
Start: August 27, 2021
End: November 8, 2027
Enrollment: 3300
What Is This Study About?
This Phase 3 clinical trial (TRAILBLAZER-ALZ 3) will test whether donanemab, also known as LY3002813, effectively reduces the risk of cognitive decline in people at risk for Alzheimer's disease. Participants will be randomly assigned to receive injections of the study drug or a placebo. This study will last up to three and half years. Researchers will measure cognitive function over time and track the immune response and the levels of study drug in the participants' blood.
Do I Qualify To Participate in This Study?
Minimum Age: 55 Years
Maximum Age: 80 Years
Must have:
- Normal cognition based on cognitive test
- Presence of amyloid plaques and abnormal tau protein in the brain
- Reliable study partner and a backup partner who are familiar with the participant's overall function and behavior, such as day-to-day activities and cognitive abilities
- Adequate literacy, vision, and hearing for neuropsychological testing at study screening
- Males must be surgically sterile or use appropriate contraception during the study
- Females must be infertile due to surgical sterilization, congenital anomaly, or post-menopause
Must NOT have:
- Mild cognitive impairment, dementia, or another significant neurodegenerative disease that can affect cognition
- Current serious or unstable illnesses that could interfere with study analysis or limit life expectancy to approximately five years
- History of cancer with a high risk of recurrence
- History of clinically significant or severe drug allergies, or severe post-treatment hypersensitivity reactions
- Any condition that could make having an MRI unsafe (e.g., claustrophobia, metal implants or devices)
- Any significant brain abnormality based on MRI or clinical laboratory test results
- Prior treatment with anti-amyloid immunotherapy recently enough that the treatment may still be in the body
- Received an anti-amyloid vaccine in another study
- Current or previous use of prescription medications for the treatment of mild cognitive impairment or Alzheimer's
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Study Contact
There may be multiple sites in this clinical trial. 1-877-CT
Need Help?
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
| Alabama | |
|---|---|
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Parkway Medical Center
Birmingham, AL 35215
Recruiting
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Tilda Research - USAL 45
Homewood, AL 35209
Recruiting
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Rehabilitation & Neurological Services
Huntsville, AL 35805
Recruiting
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| Arizona | |
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Care Access - 801 South Power Road, Mesa
Mesa, AZ 85206
Recruiting
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Banner Alzheimer's Institute
Phoenix, AZ 85006
Recruiting
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Barrow Neurological Institute
Phoenix, AZ 85013
Recruiting
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Banner Alzheimer's Institute Tucson
Tucson, AZ 85718
Recruiting
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Center for Neurosciences
Tucson, AZ 85718
Recruiting
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| California | |
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Option Care - Bakersfield
Bakersfield, CA 93313
Not yet recruiting
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Care Access - Berkeley
Berkeley, CA 94705
Recruiting
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Care Access - Beverly Hills
Beverly Hills, CA 90212
Recruiting
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Velocity Clinical Research, Chula Vista
Chula Vista, CA 91911
Recruiting
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Valley Clinical Trials, Inc.
Covina, CA 91723
Recruiting
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Neurology Center of North Orange County
Fullerton, CA 92835
Recruiting
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Care Access - Gilroy
Gilroy, CA 95020
Recruiting
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Care Access - Huntington Beach
Huntington Beach, CA 92648
Recruiting
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Tilda Research
Irvine, CA 92604
Recruiting
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Irvine Clinical Research
Irvine, CA 92614
Recruiting
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Option Care - Irvine
Irvine, CA 92618
Recruiting
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Kaizen Brain Center
La Jolla, CA 92037
Recruiting
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Velocity Clinical Research, San Diego
La Mesa, CA 91942
Recruiting
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Healthy Brain Clinic
Long Beach, CA 90804
Recruiting
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Cedars-Sinai Medical Center
Los Angeles, CA 90048
Not yet recruiting
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Neurovations
Napa, CA 94558
Recruiting
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Care Access - Newport Beach
Newport Beach, CA 92660
Recruiting
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Valley Clinical Trials, Inc.
Northridge, CA 91325
Recruiting
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Coram CVS/Specialty Infusion Services - Ontario
Ontario, CA 91761
Not yet recruiting
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Velocity Clinical Research, Panorama City
Panorama City, CA 91402
Recruiting
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Inland Psychiatric Medical Group
Redlands, CA 92373
Recruiting
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Anderson Clinical Research
Redlands, CA 92374
Recruiting
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Artemis Institute for Clinical Research
Riverside, CA 92503
Recruiting
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Option Care - Riverside
Riverside, CA 92507
Recruiting
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Option Care - Sacramento
Sacramento, CA 95816
Not yet recruiting
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Clinical Trials Research
Sacramento, CA 95821
Recruiting
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Artemis Institute for Clinical Research
San Diego, CA 92103
Recruiting
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Pacific Research Network
San Diego, CA 92103
Recruiting
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Coram CVS/Specialty Infusion Services - San Diego
San Diego, CA 92128
Not yet recruiting
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Ray Dolby Brain Health Center
San Francisco, CA 94114
Recruiting
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Care Access - Los Gatos
San Jose, CA 95124
Recruiting
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Syrentis Clinical Research
Santa Ana, CA 92705
Recruiting
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Care Access - Santa Clarita
Santa Clarita, CA 91321
Recruiting
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Option Care - Los Angeles South
Santa Fe Springs, CA 90670
Recruiting
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Providence Medical Foundation
Santa Rosa, CA 95403
Recruiting
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Mazur, Statner, Dutta, Nathan
Thousand Oaks, CA 91360
Recruiting
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Infect Disease Doctors Med Grp
Walnut Creek, CA 94598
Recruiting
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| Colorado | |
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Care Access - Aurora
Aurora, CO 80012
Recruiting
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Mountain Neurological Research Center
Basalt, CO 81621
Recruiting
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Colorado Neurological Research Center, PC
Denver, CO 80210
Recruiting
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| Connecticut | |
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Invicro
New Haven, CT 06510
Recruiting
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| Florida | |
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JEM Research Institute
Atlantis, FL 33462
Recruiting
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VIN-Julie Schwartzbard
Aventura, FL 33180
Recruiting
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Neurology Offices of South Florida
Boca Raton, FL 33428
Recruiting
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Excel Medical Clinical Trials
Boca Raton, FL 33434
Recruiting
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SFM Clinical Research
Boca Raton, FL 33487
Recruiting
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Bradenton Research Center, Inc.
Bradenton, FL 34205
Recruiting
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Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, FL 33765
Recruiting
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Care Access - Daytona Beach
Daytona Beach, FL 32114
Recruiting
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Care Access - Delray Beach
Delray Beach, FL 33484
Recruiting
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Finlay Medical Research
Greenacres City, FL 33467
Recruiting
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Indago Research & Health Center, Inc
Hialeah, FL 33012
Recruiting
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Infinity Clinical Research, LLC
Hollywood, FL 33024
Recruiting
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Jacksonville Center for Clinical Research
Jacksonville, FL 32216
Recruiting
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Coram CVS/Specialty Infusion Services - Jacksonville
Jacksonville, FL 32256
Not yet recruiting
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Optum Infusion - Jacksonville
Jacksonville, FL 32257
Not yet recruiting
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Care Access - Guava Street
Lady Lake, FL 32159
Recruiting
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Charter Research
Lady Lake, FL 32159
Recruiting
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ClinCloud - Maitland
Maitland, FL 32751
Recruiting
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K2 Medical Research
Maitland, FL 32751
Recruiting
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ClinCloud - Viera
Melbourne, FL 32940
Recruiting
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Merritt Island Medical Research, LLC
Merritt Island, FL 32952
Recruiting
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Optimus U Corporation
Miami, FL 33125
Recruiting
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Finlay Medical Research
Miami, FL 33126
Recruiting
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VIN-Andrew Lerman
Miami, FL 33133
Recruiting
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Brainstorm Research
Miami, FL 33176
Recruiting
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VIN-Victor Faradji
Miami, FL 33176
Recruiting
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San Marcus Research Clinic, Inc.
Miami Lakes, FL 33014
Recruiting
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South Florida Research Phase I-IV
Miami Springs, FL 33166
Recruiting
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Adult Medicine of Lake County
Mount Dora, FL 32757
Recruiting
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Suncoast Clinical Research, Inc.
New Port Richey, FL 34652
Recruiting
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Renstar Medical Research
Ocala, FL 34470
Recruiting
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Headlands Research Orlando
Orlando, FL 32819
Recruiting
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IMIC, Inc.
Palmetto Bay, FL 33157
Recruiting
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Pines Care Research Center
Pembroke Pines, FL 33024
Recruiting
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VIN- Margarita Almeida El-Ramey
Pembroke Pines, FL 33026
Recruiting
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Emerald Coast Neurology - Airport Boulevard
Pensacola, FL 32504
Recruiting
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Progressive Medical Research
Port Orange, FL 32127
Recruiting
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Accel Research Sites - Tampa Clinical Research Unit
Saint Petersburg, FL 33709
Recruiting
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Care Access - Pebble Beach Boulevard, Tampa
Sun City, FL 33573
Recruiting
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Care Access - Tamarac
Tamarac, FL 33321
Recruiting
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Clinical Research of West Florida
Tampa, FL 33606
Recruiting
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Stedman Clinical Trials
Tampa, FL 33613
Recruiting
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Olympian Clinical Research
Tampa, FL 33614
Recruiting
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Vicis Clinical Research
Tampa, FL 33615
Recruiting
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Coram CVS/Specialty Infusion Services - Tampa
Tampa, FL 33634
Not yet recruiting
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Palm Beach Research Center
West Palm Beach, FL 33409
Recruiting
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Conquest Research
Winter Park, FL 32789
Recruiting
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Charter Research - Winter Park
Winter Park, FL 32792
Recruiting
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| Georgia | |
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Masters of Clinical Research
Augusta, GA 30909
Recruiting
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iResearch Atlanta
Decatur, GA 30030
Recruiting
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Center for Advanced Research & Education
Gainesville, GA 30501
Recruiting
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Meridian Clinical Research, LLC
Savannah, GA 31406
Recruiting
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SKY Clinical Research Network Group-Blake
Union City, GA 30291
Recruiting
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North Georgia Clinical Research
Woodstock, GA 30189
Recruiting
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| Idaho | |
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Northwest Clinical Trials
Boise, ID 83704
Recruiting
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| Illinois | |
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IMA Clinical Research - Chicago
Chicago, IL 60602
Recruiting
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University of Chicago Medical Center
Chicago, IL 60637
Recruiting
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Great Lakes Clinical Trials - Andersonville
Chicago, IL 60640
Recruiting
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Uptown Research Institute
Chicago, IL 60640
Recruiting
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Alexian Brothers Medical Center
Elk Grove Village, IL 60007
Recruiting
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Care Access - Fairview Heights
Fairview Heights, IL 62208
Recruiting
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Great Lakes Clinical Trials - Gurnee
Gurnee, IL 60031
Recruiting
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Option Care - Chicago
Itasca, IL 60143
Not yet recruiting
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Accellacare - DuPage
Lombard, IL 60148
Recruiting
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| Indiana | |
|
Coram CVS/Specialty Infusion Services - Fort Wayne
Fort Wayne, IN 46805
Recruiting
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Care Access - West Indianapolis
Indianapolis, IN 46214
Recruiting
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Care Access - Indianapolis
Indianapolis, IN 46236
Recruiting
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Josephson Wallack Munshower Neurology, PC
Indianapolis, IN 46256
Recruiting
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| Iowa | |
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Covenant Medical Center
Waterloo, IA 50702
Recruiting
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| Kansas | |
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College Park Specialty Center
Overland Park, KS 66212
Recruiting
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| Kentucky | |
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Norton Brownsboro Hospital
Louisville, KY 40241
Recruiting
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| Louisiana | |
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Optum Infusion - Baton Rouge
Baton Rouge, LA 70809
Recruiting
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Care Access - Lake Charles
Lake Charles, LA 70601
Recruiting
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| Maryland | |
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Optum Infusion - Columbia
Columbia, MD 21046
Not yet recruiting
|
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MD Medical Research
Oxon Hill, MD 20745
Recruiting
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| Massachusetts | |
|
ActivMed Practices and Research
Methuen, MA 01844
Recruiting
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Boston Center for Memory
Newton, MA 02459
Recruiting
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Care Access - Quincy
Quincy, MA 02171
Recruiting
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MedVadis Research Corporation
Waltham, MA 02451
Recruiting
|
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| Michigan | |
|
Revival Research Institute
Sterling Heights, MI 48312
Recruiting
|
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| Minnesota | |
|
Minneapolis Clinic of Neurology - Burnsville Office
Burnsville, MN 55337
Recruiting
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Coram CVS/Specialty Infusion Services - Mendota Heights
Mendota Heights, MN 55120
Recruiting
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Optum Infusion - Roseville
Roseville, MN 55113
Not yet recruiting
|
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Option Care - St. Cloud
Sauk Rapids, MN 56379
Not yet recruiting
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| Mississippi | |
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SKY Clinical Research Network Group - Hall
Fayette, MS 39069
Recruiting
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Quinn Healthcare/SKYCRNG
Ridgeland, MS 39157
Recruiting
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| Missouri | |
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Citizens Memorial Hospital District
Bolivar, MO 65613
Recruiting
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Clinical Research Professionals
Chesterfield, MO 63005
Recruiting
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Saint Luke's Hospital of Kansas City
Kansas City, MO 64111
Not yet recruiting
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IMA Clinical Research - St. Louis
Saint Louis, MO 63117
Recruiting
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| Nevada | |
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Coram CVS/Specialty Infusion Services - Henderson
Henderson, NV 89014
Recruiting
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Option Care - Las Vegas
Las Vegas, NV 89102
Not yet recruiting
|
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Las Vegas Medical Research
Las Vegas, NV 89113
Recruiting
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| New Jersey | |
|
Amici Clinical Research
Hoboken, NJ 07030
Recruiting
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The Cognitive and Research Center of New Jersey
Springfield, NJ 07081
Recruiting
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Amici Clinical Research LLC
Warren, NJ 07059
Recruiting
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| New Mexico | |
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Albuquerque Neuroscience Inc.
Albuquerque, NM 87109
Recruiting
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| New York | |
|
IMA Clinical Research - Albany
Albany, NY 12205
Recruiting
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Neurological Associates Albany
Albany, NY 12208
Recruiting
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Prime Global Research
Bronx, NY 10456
Recruiting
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Velocity Clinical Research, Syracuse
East Syracuse, NY 13057
Recruiting
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IMA Clinical Research - Hartsdale
Hartsdale, NY 10530
Recruiting
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IMA Clinical Research Manhattan
New York, NY 10036
Recruiting
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South Shore Neurologic Associates
Patchogue, NY 11772
Recruiting
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Richmond Behavioral Associates
Staten Island, NY 10314
Recruiting
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| North Carolina | |
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Asheville Neurology Specialists
Asheville, NC 28806
Recruiting
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Care Access - Greensboro
Greensboro, NC 27401
Recruiting
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Medication Management
Greensboro, NC 27405
Recruiting
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Care Access - Hope Mills
Hope Mills, NC 28348
Recruiting
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Care Access Research-Kinston
Kinston, NC 28501
Recruiting
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Monroe Biomedical Research
Monroe, NC 28112
Recruiting
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Carteret Medical Group
Morehead City, NC 28557
Recruiting
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Care Access - Charlotte
Pineville, NC 28210
Recruiting
|
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Care Access - Raleigh
Raleigh, NC 27607
Recruiting
|
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Accellacare - Winston-Salem
Winston-Salem, NC 27103
Recruiting
|
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| Ohio | |
|
NeuroScience Research Center
Canton, OH 44718
Recruiting
|
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Wellnow Urgent Care and Research
Cincinnati, OH 45215
Recruiting
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Neurology Diagnostics, Inc.
Dayton, OH 45459
Recruiting
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Care Access - Lima
Lima, OH 45805
Recruiting
|
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North Star Medical Research
Middleburg Heights, OH 44130
Recruiting
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Option Care - Cincinnati
Milford, OH 45150
Not yet recruiting
|
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Care Access - Youngstown
Poland, OH 44514
Recruiting
|
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| Oklahoma | |
|
Coram CVS/Specialty Infusion Services - Oklahoma City
Oklahoma City, OK 73127
Not yet recruiting
|
|
|
Central States Research
Tulsa, OK 74136
Recruiting
|
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| Oregon | |
|
Optum Infusion - Bend
Bend, OR 97701
Recruiting
|
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Velocity Clinical Research - Medford
Medford, OR 97504
Recruiting
|
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Center for Cognitive Health
Portland, OR 97225
Recruiting
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| Pennsylvania | |
|
The Clinical Trial Center, LLC
Jenkintown, PA 19046
Recruiting
|
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Suburban Research Associates
Media, PA 19063
Recruiting
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Care Access - Pottsville
Pottsville, PA 17901
Recruiting
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| Rhode Island | |
|
Care Access - Warwick
Warwick, RI 02886
Recruiting
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| South Carolina | |
|
Care Access - Anderson
Anderson, SC 29621
Recruiting
|
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Velocity Clinical Research, Anderson
Anderson, SC 29621
Recruiting
|
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Velocity Clinical Research, Columbia
Columbia, SC 29204
Recruiting
|
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Velocity Clinical Research, Gaffney
Gaffney, SC 29340
Recruiting
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VitaLink Research - Greenville
Greenville, SC 29615
Recruiting
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Care Access - Mauldin
Mauldin, SC 29662
Recruiting
|
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Velocity Clinical Research, Spartanburg
Spartanburg, SC 29303
Recruiting
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VitaLink Research - Union
Union, SC 29379
Recruiting
|
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| South Dakota | |
|
Health Concepts
Rapid City, SD 57702
Recruiting
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| Tennessee | |
|
Neurology Clinic, P.C.
Cordova, TN 38018
Recruiting
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Clinical Neuroscience Solutions Inc
Memphis, TN 38119
Recruiting
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| Texas | |
|
Care Access - Austin
Austin, TX 78735
Recruiting
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Texas Diabetes & Endocrinology, P.A.
Austin, TX 78749
Recruiting
|
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|
Senior Adults Specialty Research
Austin, TX 78757
Recruiting
|
|
|
Gadolin Research
Beaumont, TX 77702
Recruiting
|
|
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Headlands Research - Brownsville
Brownsville, TX 78526
Not yet recruiting
|
|
|
Conroe Willis Medical Research
Conroe, TX 77304
Recruiting
|
|
|
Advanced Neuro Research Center - ANRC
El Paso, TX 79912
Recruiting
|
|
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Optum Infusion - Houston
Houston, TX 77054
Recruiting
|
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The University of Texas Health Science Center at Houston
Houston, TX 77054
Recruiting
|
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Next Level Urgent Care
Houston, TX 77057
Recruiting
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|
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Optum Infusion - Irving
Irving, TX 75063
Not yet recruiting
|
|
|
Family Practice Center
McAllen, TX 78501
Recruiting
|
|
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El Faro Health and Therapeutics
Rio Grande City, TX 78582
Recruiting
|
|
|
Benchmark Research - Knickerbocker
San Angelo, TX 76904
Recruiting
|
|
|
Diagnostics Research Group
San Antonio, TX 78229
Recruiting
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|
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Consano Clinical Research, LLC
Shavano Park, TX 78231
Recruiting
|
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Texas Valley Clinical Research
Weslaco, TX 78596
Recruiting
|
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| Utah | |
|
University of Utah Neurology
Salt Lake City, UT 84108
Recruiting
|
|
| Vermont | |
|
The Memory Clinic
Bennington, VT 05201-9810
Recruiting
|
|
| Virginia | |
|
Care Access - Alexandria
Alexandria, VA 22311
Recruiting
|
|
|
Option Care - Chantilly
Chantilly, VA 20151
Not yet recruiting
|
|
|
Dominion Medical Associates, Inc.
Richmond, VA 23219
Recruiting
|
|
| Washington | |
|
Northwest Clinical Research Center
Bellevue, WA 98007
Recruiting
|
|
|
Option Care - Everett
Everett, WA 98204
Not yet recruiting
|
|
|
Coram CVS/Specialty Infusion Services - Spokane Valley
Spokane Valley, WA 99212
Not yet recruiting
|
|
|
Universal Research Group
Tacoma, WA 98405
Recruiting
|
|
|
Optum Infusion - Woodinville
Woodinville, WA 98072
Recruiting
|
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| West Virginia | |
|
Option Care - Charleston WV
Charleston, WV 25304
Not yet recruiting
|
|
|
IMA Clinical Research
Morgantown, WV 26505
Recruiting
|
|
Who Sponsors This Study?
Lead: Eli Lilly and Company
Source: ClinicalTrials.gov ID: NCT05026866