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Search / Trial NCT06268886

Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease

Launched by BRISTOL-MYERS SQUIBB · Feb 13, 2024

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Alzheimer Disease Bms 986446 Neurodegenerative Disease Dementia Brain Diseases Anti Mtbr Tau Monoclonal Antibody Target Tau 1 Anti Tau Therapy

ClinConnect Summary

This clinical trial is studying a new treatment called BMS-986446, which is an antibody designed to target a specific protein linked to Alzheimer's disease. The aim is to find out if this treatment is effective, safe, and easy for people with early signs of Alzheimer’s to tolerate. The trial is currently looking for participants who show early symptoms of Alzheimer’s, such as mild cognitive impairment or mild dementia, and who meet specific criteria regarding their memory and cognitive abilities.

To be eligible for this study, participants need to be between 18 and 90 years old and have a diagnosis of mild cognitive impairment or mild Alzheimer’s disease. They should also have evidence of Alzheimer’s-related changes in their brain and specific scores on memory tests. Throughout the trial, participants can expect to undergo various assessments, including memory tests and imaging scans, to monitor their condition and how well the treatment works. It’s important for interested individuals to discuss any existing health conditions with their doctor, as certain medical issues may prevent them from participating in the study.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD dementia consistent with the National Institute on Aging and the Alzheimer's Association (NIA-AA) core clinical criteria.
  • Global Clinical Dementia Rating (CDR) score of 0.5 to 1.0 and a CDR-Memory Box score of 0.5 and greater at screening and Baseline.
  • Evidence of AD pathology.
  • Objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale IV-Logical Memory Subtest II (WMS-IV LM II).
  • Mini Mental Status Examination (MMSE) score ≥ 20 to 28 (inclusive).
  • Exclusion Criteria
  • Any evidence of a condition that may affect cognition other than AD.
  • Contraindications to PET imaging.
  • Inability to tolerate or contraindication to magnetic resonance imaging.
  • Any serious medical condition that could, in the opinion of the investigator, affect the participant's safety or interfere with study assessments.
  • Geriatric Depression Scale (GDS) score greater than or equal to 8 at screening.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

About Bristol Myers Squibb

Bristol-Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a robust portfolio of products across multiple therapeutic areas, including oncology, immunology, cardiovascular, and fibrotic diseases, BMS emphasizes cutting-edge research and a commitment to advancing medical science through clinical trials. The company is driven by a mission to provide transformative therapies, leveraging collaboration and scientific expertise to address unmet medical needs and improve patient outcomes worldwide.

Locations

Philadelphia, Pennsylvania, United States

Houston, Texas, United States

Brussels, , Belgium

Madison, Wisconsin, United States

Toronto, Ontario, Canada

Park Ridge, Illinois, United States

Ocala, Florida, United States

Barcelona, , Spain

Nashville, Tennessee, United States

New Haven, Connecticut, United States

Barcelona, , Spain

Leuven, , Belgium

Bradenton, Florida, United States

Barcelona, , Spain

East Providence, Rhode Island, United States

Barcelona, , Spain

Toronto, Ontario, Canada

Quebec, , Canada

Kodaira Shi, , Japan

Richmond, Virginia, United States

Beachwood, Ohio, United States

Miami, Florida, United States

Miami, Florida, United States

Miami, Florida, United States

Phoenix, Arizona, United States

Miami, Florida, United States

Beaumont, Texas, United States

Boston, Massachusetts, United States

Barcelona, , Spain

Lady Lake, Florida, United States

Hachioji Shi, Tokyo, Japan

Maitland, Florida, United States

Malvern, Victoria, Australia

Irvine, California, United States

Port Orange, Florida, United States

Winter Park, Florida, United States

Anderlecht, Brussels, Belgium

Miami, Florida, United States

Osaka Shi, Osaka, Japan

Naples, Florida, United States

Malvern, Victoria, Australia

Fullerton, California, United States

Miami, Florida, United States

Osaka Shi, , Japan

Pamplona, , Spain

Incheon, , Korea, Republic Of

Braintree, Massachusetts, United States

Macquarie Park, New South Wales, Australia

Nedlands, Western Australia, Australia

Chandler, Arizona, United States

Gilbert, Arizona, United States

Scottsdale, Arizona, United States

Scottsdale, Arizona, United States

Tucson, Arizona, United States

Tucson, Arizona, United States

Tucson, Arizona, United States

Encino, California, United States

Fullerton, California, United States

La Jolla, California, United States

Lomita, California, United States

Los Alamitos, California, United States

Napa, California, United States

San Francisco, California, United States

Santa Ana, California, United States

Seal Beach, California, United States

Sherman Oaks, California, United States

Englewood, Colorado, United States

Danbury, Connecticut, United States

New Haven, Connecticut, United States

New Haven, Connecticut, United States

Stamford, Connecticut, United States

Altamonte Springs, Florida, United States

Atlantis, Florida, United States

Daytona Beach, Florida, United States

Greenacres City, Florida, United States

Lady Lake, Florida, United States

Lakeland, Florida, United States

Maitland, Florida, United States

Merritt Island, Florida, United States

Miami, Florida, United States

Miami, Florida, United States

Miami, Florida, United States

Miami, Florida, United States

Miami, Florida, United States

Miami, Florida, United States

Miami, Florida, United States

Miami, Florida, United States

Miami, Florida, United States

New Port Richey, Florida, United States

Ocala, Florida, United States

Ocoee, Florida, United States

Orlando, Florida, United States

Palm Beach Gardens, Florida, United States

Stuart, Florida, United States

Stuart, Florida, United States

Tampa, Florida, United States

Tampa, Florida, United States

Tampa, Florida, United States

Wellington, Florida, United States

West Palm Beach, Florida, United States

Windermere, Florida, United States

Winter Park, Florida, United States

Winter Park, Florida, United States

Columbus, Georgia, United States

Chicago, Illinois, United States

Elk Grove Village, Illinois, United States

Gurnee, Illinois, United States

Park Ridge, Illinois, United States

Springfield, Illinois, United States

Boston, Massachusetts, United States

Braintree, Massachusetts, United States

Methuen, Massachusetts, United States

Newton, Massachusetts, United States

Plymouth, Massachusetts, United States

Watertown, Massachusetts, United States

Ozark, Missouri, United States

Saint Louis, Missouri, United States

Portsmouth, New Hampshire, United States

Princeton, New Jersey, United States

Toms River, New Jersey, United States

West Long Branch, New Jersey, United States

Albany, New York, United States

Amherst, New York, United States

Manhasset, New York, United States

New Hyde Park, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Matthews, North Carolina, United States

Beachwood, Ohio, United States

Abington, Pennsylvania, United States

Plymouth Meeting, Pennsylvania, United States

East Providence, Rhode Island, United States

Providence, Rhode Island, United States

Providence, Rhode Island, United States

Cordova, Tennessee, United States

Franklin, Tennessee, United States

Austin, Texas, United States

Dallas, Texas, United States

Dallas, Texas, United States

Houston, Texas, United States

Round Rock, Texas, United States

Round Rock, Texas, United States

Richmond, Virginia, United States

Darlinghurst, New South Wales, Australia

East Gosford, New South Wales, Australia

Macquarie Park, New South Wales, Australia

Southport, Queensland, Australia

Carlton North, Victoria, Australia

Heidelberg, Victoria, Australia

Melbourne, Victoria, Australia

Parkville, Victoria, Australia

Nedlands, Western Australia, Australia

Anderlecht, Brussels, Belgium

Brussel, Bru, Belgium

Kortrijk, Vwv, Belgium

Liege, Wlg, Belgium

Brussels, , Belgium

Leuven, , Belgium

Kelowna, British Columbia, Canada

West Vancouver, British Columbia, Canada

Peterborough, Ontario, Canada

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Gatineau, Quebec, Canada

Greenfield Park, Quebec, Canada

Montreal, Quebec, Canada

Montreal, Quebec, Canada

Quebec, , Canada

Aarhus N, Aarhus, Denmark

Copenhagen, , Denmark

Esbjerg, , Denmark

Angers, , France

Limoges Cedex, , France

Nantes, , France

Paris, , France

Rouen, , France

Toulouse, , France

Villeurbanne, , France

Gwangjingu, , Korea, Republic Of

Incheon, , Korea, Republic Of

Junggu, , Korea, Republic Of

Seoul, , Korea, Republic Of

Amsterdam, Nh, Netherlands

Haarlem, Nh, Netherlands

Breda, North Brabant, Netherlands

'S Hertogenbosch, , Netherlands

Pruszkow, Mz, Poland

Warszawa, Mz, Poland

Poznan, , Poland

Szczecin, , Poland

Singapore, , Singapore

Barcelona, B, Spain

Barcelona, B, Spain

Sant Cugat Del Vallès, Ct, Spain

Madrid, M, Spain

Pozuelo De Alarcon, M, Spain

Barcelona, , Spain

Barcelona, , Spain

Sevilla, , Spain

Malmo, M, Sweden

Uppsala, Uppsala Lan, Sweden

Huddinge, , Sweden

Uppsala, , Sweden

Winchester, Ham, United Kingdom

Enfield, Lnd, United Kingdom

London, Lnd, United Kingdom

London, Lnd, United Kingdom

Guildford, Sry, United Kingdom

Leatherhead, Sry, United Kingdom

Bristol, , United Kingdom

Amherst, New York, United States

Greenacres City, Florida, United States

Miami, Florida, United States

Orlando, Florida, United States

Antwerpen, Brussel, Belgium

Ottawa, Ontario, Canada

Kodaira Shi, , Japan

Nagoya Shi, , Japan

Nagoya Shi, , Japan

Osaka Shi, , Japan

Zwolle, Ov, Netherlands

Lakewood, California, United States

Clermont, Florida, United States

Jacksonville, Florida, United States

Madison, Wisconsin, United States

Bunkyo Ku, , Japan

Kasukabe Shi, , Japan

Kurashiki Shi, , Japan

Setagaya Ku, , Japan

Songpa Gu, Seoul, Korea, Republic Of

Songpa Gu, Seoul, Korea, Republic Of

Irvine, California, United States

Clermont, Florida, United States

Hialeah, Florida, United States

Maitland, Florida, United States

Maitland, Florida, United States

Miami Springs, Florida, United States

Miami, Florida, United States

Miami, Florida, United States

Miami, Florida, United States

Miami, Florida, United States

Orlando, Florida, United States

Orlando, Florida, United States

Sarasota, Florida, United States

Tampa, Florida, United States

Viera, Florida, United States

Fairfax, Virginia, United States

Montreal, Quebec, Canada

Himeji Shi, , Japan

Toyonaka Shi, , Japan

'S Hertogenbosch, Nb, Netherlands

Tucson, Arizona, United States

Sacramento, California, United States

Englewood, Colorado, United States

Fort Myers, Florida, United States

Hialeah, Florida, United States

Hialeah, Florida, United States

Miami, Florida, United States

Miami, Florida, United States

Miami, Florida, United States

Naples, Florida, United States

Port Orange, Florida, United States

Chicago, Illinois, United States

West Long Branch, New Jersey, United States

Brooklyn, New York, United States

New York, New York, United States

Dayton, Ohio, United States

North Canton, Ohio, United States

Abington, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Providence, Rhode Island, United States

Round Rock, Texas, United States

Bremen, Hb, Germany

Rome, , Italy

Nagoya Shi, Aichi, Japan

Bunkyo Ku, Tokyo, Japan

Setagaya Ku, Tokyo, Japan

Scottsdale, Arizona, United States

Boca Raton, Florida, United States

Bradenton, Florida, United States

Miami, Florida, United States

Orlando, Florida, United States

West Palm Beach, Florida, United States

Nashville, Tennessee, United States

Chuo Ku, , Japan

Hachioji Shi, , Japan

Musashimurayama Shi, , Japan

Musashino Shi, , Japan

Toride Shi, , Japan

Encino, California, United States

Long Beach, California, United States

Santa Ana, California, United States

New Haven, Connecticut, United States

Stamford, Connecticut, United States

Boca Raton, Florida, United States

Boca Raton, Florida, United States

Lake Mary, Florida, United States

Lakeland, Florida, United States

Miami, Florida, United States

Orlando, Florida, United States

Orlando, Florida, United States

Stuart, Florida, United States

West Palm Beach, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Elk Grove Village, Illinois, United States

Boston, Massachusetts, United States

Foxboro, Massachusetts, United States

Charlottesville, Virginia, United States

Montreal, Quebec, Canada

Nagoya Shi, Aichi, Japan

Hirakata Shi, , Japan

Kurashiki Shi, , Japan

Nagoya Shi, , Japan

Obu, , Japan

Tachikawa Shi, , Japan

Takatsuki Shi, , Japan

Lleida, L, Spain

Birmingham, Bir, United Kingdom

Bristol, Bst, United Kingdom

Southampton, Hampshire, United Kingdom

Southampton, Ham, United Kingdom

Bath, Som, United Kingdom

Tampa, Florida, United States

New York, New York, United States

East Gosford, New South Wales, Australia

Los Alamitos, California, United States

Santa Ana, California, United States

Hialeah, Florida, United States

Miami, Florida, United States

Miami, Florida, United States

New York, New York, United States

Fairfax, Virginia, United States

Ivanhoe, Victoria, Australia

Toride Shi, Ibaraki, Japan

Hirakata Shi, Osaka, Japan

Osaka Shi, Osaka, Japan

Toyonaka Shi, Osaka, Japan

Bunkyo Ku, Tokyo, Japan

Hachioji Shi, , Japan

Musashimurayama Shi, , Japan

Obu, , Japan

London, Lnd, United Kingdom

Long Beach, California, United States

Orlando, Florida, United States

Viera, Florida, United States

Griffith University, Queensland, Australia

Kurashiki Shi, , Japan

Osaka Shi, , Japan

Scottsdale, Arizona, United States

San Francisco, California, United States

Danbury, Connecticut, United States

Boca Raton, Florida, United States

Boca Raton, Florida, United States

Bradenton, Florida, United States

Fort Myers, Florida, United States

Hialeah, Florida, United States

Miami Springs, Florida, United States

Miami, Florida, United States

Naples, Florida, United States

Orlando, Florida, United States

Boston, Massachusetts, United States

Franklin, Tennessee, United States

Austin, Texas, United States

Griffith University, Queensland, Australia

Carlton North, Victoria, Australia

Ivanhoe, Victoria, Australia

Setagaya Ku, Tokyo, Japan

Himeji Shi, , Japan

Toride Shi, , Japan

Enfield, Lnd, United Kingdom

Leatherhead, Sry, United Kingdom

Hialeah, Florida, United States

Tampa, Florida, United States

West Palm Beach, Florida, United States

Dayton, Ohio, United States

Kortrijk, Vwv, Belgium

Ottawa, Ontario, Canada

Toronto, Ontario, Canada

Greenfield Park, Quebec, Canada

Hirakata Shi, , Japan

Kasukabe Shi, , Japan

Musashino Shi, , Japan

Tachikawa Shi, , Japan

Takatsuki Shi, , Japan

Sant Cugat Del Vallès, Ct, Spain

Miami, Florida, United States

Chicago, Illinois, United States

Chuo Ku, , Japan

Macquaire Park, New South Wales, Australia

Melbourne, Victoria, Australia

Kurashiki Shi, , Japan

Barcelona, B, Spain

Malmo, M, Sweden

London, Lnd, United Kingdom

Miami, Florida, United States

Miami, Florida, United States

Antwerpen, Brussel, Belgium

Hirakata Shi, Osaka, Japan

Gwangjingu, , Korea, Republic Of

Junggu, , Korea, Republic Of

San Francisco, California, United States

Sarasota, Florida, United States

Providence, Rhode Island, United States

Montreal, Quebec, Canada

Kurashiki Shi, Okayama, Japan

Tachikawa Shi, , Japan

Toride Shi, , Japan

Bath, Som, United Kingdom

Toride Shi, Ibaraki, Japan

Sacramento, California, United States

Parkville, Victoria, Australia

Orlando, Florida, United States

Toyonaka Shi, , Japan

Singapore, , Singapore

Lleida, L, Spain

Hialeah, Florida, United States

Chertsey, Surrey, United Kingdom

Napa, California, United States

Sacramento, California, United States

Orlando, Florida, United States

Gurnee, Illinois, United States

Springfield, Illinois, United States

Boston, Massachusetts, United States

Portsmouth, New Hampshire, United States

Independence, Ohio, United States

Tampa, Florida, United States

Hachioji Shi, Tokyo, Japan

Patients applied

0 patients applied

Trial Officials

Bristol-Myers Squibb

Study Director

Bristol-Myers Squibb

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported