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 24, 2025
Recruiting
Keywords
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported