221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease
Launched by BIOGEN · Jun 18, 2015
Trial Information
Current as of June 24, 2025
Terminated
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- * Must meet all of the following clinical criteria for MCI due to AD or mild AD and must have:
- • A Clinical Dementia Rating (CDR)-Global Score of 0.5.
- • Objective evidence of cognitive impairment at screening
- • An MMSE score between 24 and 30 (inclusive)
- • Must have a positive amyloid Positron Emission Tomography (PET) scan
- • Must consent to apolipoprotein E (ApoE) genotyping
- • If using drugs to treat symptoms related to AD, doses must be stable for at least 8 weeks prior to screening visit 1
- • Must have a reliable informant or caregiver
- Key Exclusion Criteria:
- • Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the subject's cognitive impairment
- • Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year
- • Clinically significant unstable psychiatric illness in past 6 months
- • History of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to Screening
- • Indication of impaired renal or liver function
- • Have human immunodeficiency virus (HIV) infection
- • Have a significant systematic illness or infection in past 30 days
- • Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
- • Any contraindications to brain magnetic resonance imaging (MRI) or PET scans
- • Alcohol or substance abuse in past 1 year
- • Taking blood thinners (except for aspirin at a prophylactic dose or less)
- • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
About Biogen
Biogen is a leading biotechnology company dedicated to discovering, developing, and delivering innovative therapies for neurological and neurodegenerative diseases. With a strong focus on research and development, Biogen leverages advanced science and cutting-edge technology to address the unmet needs of patients suffering from conditions such as multiple sclerosis, Alzheimer's disease, and spinal muscular atrophy. The company is committed to advancing the understanding of the underlying biology of these diseases and is actively engaged in clinical trials to evaluate new treatment options, aiming to improve patient outcomes and enhance quality of life. With a global presence and a robust pipeline of therapies, Biogen is at the forefront of innovation in the biopharmaceutical industry.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Pittsburgh, Pennsylvania, United States
Houston, Texas, United States
West Palm Beach, Florida, United States
Rochester, New York, United States
Verdun, Quebec, Canada
Indianapolis, Indiana, United States
Boston, Massachusetts, United States
Heidelberg, Victoria, Australia
Parkville, Victoria, Australia
Phoenix, Arizona, United States
Box Hill, Victoria, Australia
Miami, Florida, United States
Cleveland, Ohio, United States
Weston, Florida, United States
Park Ridge, Illinois, United States
Jacksonville, Florida, United States
Palm Beach Gardens, Florida, United States
Albany, New York, United States
New Haven, Connecticut, United States
Providence, Rhode Island, United States
Los Angeles, California, United States
Fort Wayne, Indiana, United States
Oklahoma City, Oklahoma, United States
Taipei, , Taiwan
Barcelona, , Spain
Changhua, , Taiwan
Jenkintown, Pennsylvania, United States
Laguna Hills, California, United States
Lexington, Kentucky, United States
Memphis, Tennessee, United States
Delray Beach, Florida, United States
Tampa, Florida, United States
Valencia, , Spain
Seoul, , Korea, Republic Of
Charleston, South Carolina, United States
Seoul, , Korea, Republic Of
Toronto, Ontario, Canada
Barakaldo, Vizcaya, Spain
Waratah, New South Wales, Australia
Milano, , Italy
Brescia, , Italy
Tainan, , Taiwan
Vancouver, British Columbia, Canada
Dallas, Texas, United States
Kaohsiung, , Taiwan
London, Greater London, United Kingdom
Fort Myers, Florida, United States
Chermside, Queensland, Australia
Penticton, British Columbia, Canada
Seoul, , Korea, Republic Of
Genova, , Italy
Seoul, , Korea, Republic Of
Madrid, , Spain
Roma, , Italy
Barcelona, , Spain
Fullerton, California, United States
Miami, Florida, United States
Elk Grove Village, Illinois, United States
Washington, District Of Columbia, United States
East Providence, Rhode Island, United States
København ø, , Denmark
Incheon, , Korea, Republic Of
Pisa, , Italy
Tucson, Arizona, United States
Kansas City, Kansas, United States
Bergamo, , Italy
Darlinghurst, New South Wales, Australia
Methuen, Massachusetts, United States
Siena, , Italy
Seongnam Si, Gyeonggi Do, Korea, Republic Of
Lomita, California, United States
Toronto, Ontario, Canada
Napoli, , Italy
Valencia, , Spain
Tampa, Florida, United States
Kaohsiung, , Taiwan
Erina, New South Wales, Australia
Quebec, , Canada
Barcelona, , Spain
Hannover, Niedersachsen, Germany
Braga, , Portugal
New York, New York, United States
Bron Cedex, Rhone, France
Paris, , France
Wichita, Kansas, United States
Taoyuan County, , Taiwan
Loures, , Portugal
Napoli, , Italy
Herston, Queensland, Australia
West Perth, Western Australia, Australia
Kiyose Shi, , Japan
Torres Vedras, , Portugal
Milwaukee, Wisconsin, United States
San Francisco, California, United States
Sherman Oaks, California, United States
Simi Valley, California, United States
Orlando, Florida, United States
Tampa, Florida, United States
The Villages, Florida, United States
Boston, Massachusetts, United States
Plymouth, Massachusetts, United States
Saint Louis, Missouri, United States
Las Vegas, Nevada, United States
Toms River, New Jersey, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Plains, Pennsylvania, United States
Cordova, Tennessee, United States
Knoxville, Tennessee, United States
Richmond, Virginia, United States
East Gosford, New South Wales, Australia
North Ryde, New South Wales, Australia
Toowoomba, Queensland, Australia
Graz, , Austria
Salzburg, , Austria
Calgary, Alberta, Canada
Montreal, Quebec, Canada
Ballerup, , Denmark
Vejle, , Denmark
ålborg, , Denmark
Strasbourg Cedex, Bas Rhin, France
Strasbourg, Bas Rhin, France
Bordeaux, Gironde, France
Reims, Marne, France
Paris, , France
Boeblingen, Baden Wuerttemberg, Germany
Ostfildern, Baden Wuerttemberg, Germany
Stuttgart, Baden Wuerttemberg, Germany
Frankfurt, Bayern, Germany
Neuburg, Bayern, Germany
Kassel, Hessen, Germany
Aachen, Nordrhein Westfalen, Germany
Bonn, Nordrhein Westfalen, Germany
Cologne, Nordrhein Westfalen, Germany
Berlin, , Germany
Torrette Di Ancona, Ancona, Italy
Cefalù, Palermo, Italy
Milano, , Italy
Salerno, , Italy
Chiba Shi, Chiba Ken, Japan
Inzai Shi, Chiba Ken, Japan
Kurume Shi, Fukuoka Ken, Japan
Aizuwakamatsu Shi, Fukushima Ken, Japan
Asahikawa Shi, Hokkaido, Japan
Sapporo Shi, Hokkaido, Japan
Atsugi Shi, Kanagawa Ken, Japan
Kamakura Shi, Kanagawa Ken, Japan
Kawasaki Shi, Kanagawa Ken, Japan
Yokohama Shi, Kanagawa Ken, Japan
Yokohama Shi, Kanagawa Ken, Japan
Kyoto Shi, Kyoto Fu, Japan
Nagaoka Shi, Niigata Ken, Japan
Iruma Gun, Saitama Ken, Japan
Kasukabe Shi, Saitama Ken, Japan
Bunkyo Ku, Tokyo To, Japan
Shinjuku Ku (I), Tokyo To, Japan
Shinjuku Ku, Tokyo To, Japan
Ota Ku, Tokyo, Japan
Yamagata Shi, Yamagata Ken, Japan
Itabashi Ku, , Japan
Kodaira Shi, , Japan
Incheon, Gyeonggi Do, Korea, Republic Of
Amadora, , Portugal
Coimbra, , Portugal
Lisboa, , Portugal
San Sebastian, Guipuzcoa, Spain
Bristol, Avon, United Kingdom
London, Greater London, United Kingdom
London, Greater London, United Kingdom
Salford, Greater Manchester, United Kingdom
Edinburgh, Lothian Region, United Kingdom
Blackburn, Merseyside, United Kingdom
Bath, Somerset, United Kingdom
Glasgow, Strathclyde, United Kingdom
Glasgow, Strathclyde, United Kingdom
Dundee, Tayside Region, United Kingdom
Newcastle Upon Tyne, Tyne & Wear, United Kingdom
Chippenham, Wiltshire, United Kingdom
Patients applied
Trial Officials
Medical Director
Study Director
Biogen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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