Last updated on December 2019

Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)


Brief description of study

This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible participants will be randomized 1:1 to receive either subcutaneous (SC) injection of gantenerumab or placebo. The primary efficacy assessment will be performed at the end of the double blind period at week 104. Participants will then be offered to enter into an open-label extension (OLE). Participants not willing to go to the OLE will participate in a long term follow-up period for up to 50 weeks after the last gantenerumab dose.

Clinical Study Identifier: NCT03443973

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Mayo Clinic

Scottsdale, AZ United States
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Bradenton, FL United States
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Brooksville, FL United States
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Ocala, FL United States
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Port Orange, FL United States
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Decatur, GA United States
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Brooklyn, NY United States
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Greensboro, NC United States
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Oklahoma City, OK United States
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BG Neurology, LLC

Spartanburg, SC United States
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Core Clinical Research

Everett, WA United States
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UZ Gent

Gent, Belgium
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CRST Oy

Turku, Finland
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Dong-A University Hospital

Busan, Korea, Republic of
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Gyeonggi-do, Korea, Republic of
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Gyeonggi-do, Korea, Republic of
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Incheon, Korea, Republic of
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Seoul, Korea, Republic of
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Tucson, AZ United States
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San Diego, CA United States
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Augusta, GA United States
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Boston Center for Memory

Newton, MA United States
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Behavioral Health Research

Charlotte, NC United States
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Alzheimer's Memory Center

Charlotte, NC United States
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Winston-Salem, NC United States
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Summit Research Network Inc.

Portland, OR United States
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Kingfisher Cooperative

Spokane, WA United States
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Health Initiatives Research, PLLC

Fayetteville, AR United States
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Maitland, FL United States
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Atlanta, GA United States
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Bangor, ME United States
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Farmington Hills, MI United States
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Missouri Memory Center

Bolivar, MO United States
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Saint Louis, MO United States
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Rochester, NY United States
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Oklahoma City, OK United States
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Sarasota, FL United States
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Lexington, KY United States
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Staten Island, NY United States
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Dallas, TX United States
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Hospital Italiano

Buenos Aires, Argentina
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Miami, FL United States
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Flower Mound, TX United States
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Redlands, CA United States
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Córdoba, Argentina
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Bydgoszcz, Poland
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Warszawawa, Poland
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Wroc?aw, Poland
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Birmingham, United Kingdom
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Dundee, United Kingdom
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London, United Kingdom
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RE:Cognition Health

London, United Kingdom
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London, United Kingdom
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Campus for Ageing and Vitality

Newcastle Upon Tyne, United Kingdom
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Royal Preston Hospital

Preston, United Kingdom
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