Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease
- Conditions
- Alzheimer Disease, Early Onset
- Interventions
- Other: Placebo
- Registration Number
- NCT06268886
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to assess the effectiveness, safety, and tolerability of BMS-986446 an Anti-MTBR Tau Monoclonal Antibody in participants with Early Alzheimer's Disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 310
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - BMS-986446 Dose B BMS-986446 - BMS-986446 Dose A BMS-986446 -
- Primary Outcome Measures
Name Time Method Change from baseline in brain tau deposition as measured by tau positron emission tomography (PET) At week 76
- Secondary Outcome Measures
Name Time Method Change from baseline in Alzheimer's Disease Cooperative Study-instrumental Activities of Daily Living scale (ADCS-iADL) score At week 76 Change from baseline in Mini Mental State Examination (MMSE) score At week 76 Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADASCog14) score At week 76 Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score At week 76 Change from baseline in integrated Alzheimer's Disease Rating Scale (iADRS) score At week 76
Trial Locations
- Locations (203)
Hatsuta Neurology Clinic
🇯🇵Hirakata-Shi, Osaka, Japan
Tominaga Clinic
🇯🇵Osaka-shi, Osaka, Japan
Memory Clinic Ochanomizu
🇯🇵Bunkyo-Ku, Tokyo, Japan
P-One Clinic
🇯🇵Hachioji-Shi, Tokyo, Japan
Kanto Central Hospital of the Mutual Aid Association of Public School Teachers
🇯🇵Setagaya-Ku, Tokyo, Japan
Tokyo Asubo Clinic
🇯🇵Chuo-Ku, Japan
Hyogo Prefectural Harima Himeji General Medical Center
🇯🇵Himeji-shi, Japan
Local Institution - 0188
🇯🇵Kasukabe-Shi, Japan
National Center Of Neurology And Psychiatry
🇯🇵Kodaira-Shi, Japan
Musashimurayama Hospital
🇯🇵Musashimurayama-Shi, Japan
Japanese Red Cross Musashino Hospital
🇯🇵Musashino-shi, Japan
Meitetsu Hospital
🇯🇵Nagoya-Shi, Japan
National Center for Geriatrics and Gerontology (NCGG)
🇯🇵Obu, Japan
Osaka Metropolitan University Hospital
🇯🇵Osaka-shi, Japan
Local Institution - 0240
🇯🇵Tachikawa-Shi, Japan
MD First Research - Chandler
🇺🇸Chandler, Arizona, United States
Gilbert Neurology
🇺🇸Gilbert, Arizona, United States
Xenoscience Inc. - 21st Century Neurology
🇺🇸Phoenix, Arizona, United States
Perseverance Research Center (PRC)
🇺🇸Scottsdale, Arizona, United States
Imaging Endpoints LLC
🇺🇸Scottsdale, Arizona, United States
Center for Neurosciences - Tucson
🇺🇸Tucson, Arizona, United States
The Banner Alzheimer's Institute - Tucson
🇺🇸Tucson, Arizona, United States
Pharmacology Research Institute (PRI) - Encino
🇺🇸Encino, California, United States
Neurology Center of North Orange County
🇺🇸Fullerton, California, United States
Irvine Center for Clinical Research
🇺🇸Irvine, California, United States
Local Institution - 0073
🇺🇸Lomita, California, United States
Healthy Brain Clinic
🇺🇸Long Beach, California, United States
Local Institution - 0142
🇺🇸Los Alamitos, California, United States
Local Institution - 0037
🇺🇸Napa, California, United States
University of California Davis (UC Davis) - Alzheimer's Disease Center (ADC) - Sacramento
🇺🇸Sacramento, California, United States
UCSF Medical Center at Mission Bay
🇺🇸San Francisco, California, United States
Local Institution - 0183
🇺🇸Santa Ana, California, United States
Syrentis Clinical Research
🇺🇸Santa Ana, California, United States
California Neuroscience Research Medical Group, Inc (CNR)
🇺🇸Sherman Oaks, California, United States
Local Institution - 0106
🇺🇸Danbury, Connecticut, United States
Local Institution - 0229
🇺🇸New Haven, Connecticut, United States
Yale School Of Medicine
🇺🇸New Haven, Connecticut, United States
Hasbani Neurology
🇺🇸New Haven, Connecticut, United States
New England Institute for Neurology and Headache (NEINH)
🇺🇸Stamford, Connecticut, United States
Neurology of Central Florida
🇺🇸Altamonte Springs, Florida, United States
JEM Research Institute
🇺🇸Atlantis, Florida, United States
Neurology Offices of South Florida - Boca Raton
🇺🇸Boca Raton, Florida, United States
Local Institution - 0251
🇺🇸Boca Raton, Florida, United States
SFM Clinical Research, LLC
🇺🇸Boca Raton, Florida, United States
Bradenton Research Center, Inc.
🇺🇸Bradenton, Florida, United States
K2 Medical Research - Winter Garden
🇺🇸Clermont, Florida, United States
Arrow Clinical Trials
🇺🇸Daytona Beach, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
🇺🇸Fort Myers, Florida, United States
Finlay Medical Research (FMR) Corporation - Greenacres
🇺🇸Greenacres City, Florida, United States
Indago Research and Health Center, Inc.
🇺🇸Hialeah, Florida, United States
Health Care Family Rehab & Research Center
🇺🇸Hialeah, Florida, United States
Local Institution - 0198
🇺🇸Hialeah, Florida, United States
Charter Research - Lady Lake
🇺🇸Lady Lake, Florida, United States
Local Institution - 0246
🇺🇸Lake Mary, Florida, United States
Accel Research Sites - Lakeland Clinical Research Unit
🇺🇸Lakeland, Florida, United States
ClinCloud LLC
🇺🇸Maitland, Florida, United States
Neurology & Movement Disorders Healthcare
🇺🇸Maitland, Florida, United States
Merritt Island Medical Research
🇺🇸Merritt Island, Florida, United States
South Florida Research Phase I-IV, Inc
🇺🇸Miami Springs, Florida, United States
Homestead Associates in Research, Inc.
🇺🇸Miami, Florida, United States
Premier Clinical Research Institute - Miami
🇺🇸Miami, Florida, United States
Local Institution - 0013
🇺🇸Miami, Florida, United States
Project 4 Research
🇺🇸Miami, Florida, United States
Finlay Medical Research Corp.
🇺🇸Miami, Florida, United States
CCM Clinical Research Group
🇺🇸Miami, Florida, United States
Vitae Research Center
🇺🇸Miami, Florida, United States
Advance Medical Research Center
🇺🇸Miami, Florida, United States
Advanced Clinical Research Network, Corp
🇺🇸Miami, Florida, United States
Miami Jewish Health Systems
🇺🇸Miami, Florida, United States
Local Institution - 0199
🇺🇸Miami, Florida, United States
Global Life Research LLC
🇺🇸Miami, Florida, United States
Local Institution - 0201
🇺🇸Miami, Florida, United States
Ivetmar Medical Group LLC
🇺🇸Miami, Florida, United States
Hope Research Network, LLC
🇺🇸Miami, Florida, United States
EZY Medical Research
🇺🇸Miami, Florida, United States
First Choice Neurology - Medical Arts Neurology
🇺🇸Miami, Florida, United States
IMIC Research
🇺🇸Miami, Florida, United States
Miami Dade Medical Research Institute
🇺🇸Miami, Florida, United States
Aqualane Clinical Research
🇺🇸Naples, Florida, United States
Suncoast Clinical Research
🇺🇸New Port Richey, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
K2 Medical Research - South Orlando
🇺🇸Orlando, Florida, United States
Local Institution - 0219
🇺🇸Orlando, Florida, United States
Headlands Research - Orlando
🇺🇸Orlando, Florida, United States
Brain, Spine and Pain Institute of Lake Nona
🇺🇸Orlando, Florida, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Intercoastal Medical Group, Inc. - Hyde Park East & West
🇺🇸Sarasota, Florida, United States
Alzheimer's Research and Treatment Center Stuart
🇺🇸Stuart, Florida, United States
Brain Matters Research - Stuart
🇺🇸Stuart, Florida, United States
K2 Medical Research - Tampa
🇺🇸Tampa, Florida, United States
Baycare Clinical Research, LLC
🇺🇸Tampa, Florida, United States
Axiom Brain Health
🇺🇸Tampa, Florida, United States
Johnnie B. Byrd, Sr. Alzheimer's Foundation, Inc
🇺🇸Tampa, Florida, United States
Clincloud Clinical Research
🇺🇸Viera, Florida, United States
Alzheimer's Research and Treatment Center - Wellington Location
🇺🇸Wellington, Florida, United States
Palm Beach Neurology Premiere Research Institute
🇺🇸West Palm Beach, Florida, United States
Quantum Laboratories, Inc - West Palm Beach Office
🇺🇸West Palm Beach, Florida, United States
Waypoint Research LLC
🇺🇸Windermere, Florida, United States
Conquest Research LLC
🇺🇸Winter Park, Florida, United States
Charter Research - Winter Park
🇺🇸Winter Park, Florida, United States
Local Institution - 0241
🇺🇸Atlanta, Georgia, United States
Columbus Memory Center
🇺🇸Columbus, Georgia, United States
Cognition Health - Chicago
🇺🇸Chicago, Illinois, United States
Great Lakes Clinical Trials
🇺🇸Chicago, Illinois, United States
Alexian Brothers Neurosciences Institute
🇺🇸Elk Grove Village, Illinois, United States
Local Institution - 0003
🇺🇸Gurnee, Illinois, United States
Advocate Lutheran General Hospital
🇺🇸Park Ridge, Illinois, United States
Local Institution - 0081
🇺🇸Springfield, Illinois, United States
Copley Clinical
🇺🇸Boston, Massachusetts, United States
Local Institution - 0182
🇺🇸Boston, Massachusetts, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Alzheimer Disease Center
🇺🇸Braintree, Massachusetts, United States
Neurology Center of New England, PC
🇺🇸Foxboro, Massachusetts, United States
ActivMed Practices & Research, Inc. - Methuen
🇺🇸Methuen, Massachusetts, United States
Boston Center for Memory
🇺🇸Newton, Massachusetts, United States
Office of Donald S. Marks, M.D., P.C.
🇺🇸Plymouth, Massachusetts, United States
Adams Clinical Trials, LLC
🇺🇸Watertown, Massachusetts, United States
Local Institution - 0169
🇺🇸Saint Louis, Missouri, United States
Local Institution - 0119
🇺🇸Portsmouth, New Hampshire, United States
Princeton Medical Institute
🇺🇸Princeton, New Jersey, United States
Advanced Memory Research Institute of NJ
🇺🇸Toms River, New Jersey, United States
Neurological Associates of Albany, P.C.
🇺🇸Albany, New York, United States
Dent Neurologic Institute - Amherst
🇺🇸Amherst, New York, United States
The Feinstein Institute for Medical Research
🇺🇸Manhasset, New York, United States
Berman Clinical
🇺🇸New York, New York, United States
Icahn School of Medicine at Mount Sinai (ISMMS) - Alzheimer's Disease Research Center
🇺🇸New York, New York, United States
Columbia University Medical Center - The Neurological Institute of New York
🇺🇸New York, New York, United States
Alzheimer's Memory Center
🇺🇸Matthews, North Carolina, United States
Neurology Diagnostics, Inc.
🇺🇸Dayton, Ohio, United States
Local Institution - 0155
🇺🇸Independence, Ohio, United States
Local Institution - 0216
🇺🇸North Canton, Ohio, United States
Keystone Clinical Studies, LLC
🇺🇸Plymouth Meeting, Pennsylvania, United States
Rhode Island Mood & Memory Research Institute
🇺🇸East Providence, Rhode Island, United States
Butler Hospital
🇺🇸Providence, Rhode Island, United States
Neurology Clinic, P.C. - Germantown Park Location
🇺🇸Cordova, Tennessee, United States
Local Institution - 0140
🇺🇸Franklin, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Senior Adults Specialty Research
🇺🇸Austin, Texas, United States
Gadolin Research
🇺🇸Beaumont, Texas, United States
Kerwin Research Center and Memory Care
🇺🇸Dallas, Texas, United States
Neurology Consultants of Dallas
🇺🇸Dallas, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Memorial Neurological Association - Main Office
🇺🇸Houston, Texas, United States
Be Well MD
🇺🇸Round Rock, Texas, United States
Local Institution - 0233
🇺🇸Charlottesville, Virginia, United States
Re:Cognition Health - Fairfax
🇺🇸Fairfax, Virginia, United States
National Clinical Research - Richmond, Inc.
🇺🇸Richmond, Virginia, United States
Local Institution - 0065
🇺🇸Madison, Wisconsin, United States
Central Coast Neuroscience Research - East Gosford
🇦🇺East Gosford, New South Wales, Australia
KaRa Institute of Neurological Disease Pty Ltd
🇦🇺Macquarie Park, New South Wales, Australia
Griffith University - Clinical Trial Unit - Gold Coast Campus
🇦🇺Griffith University, Queensland, Australia
NeuroCentrix
🇦🇺Carlton North, Victoria, Australia
Austin Health - Heidelberg Repatriation Hospital
🇦🇺Ivanhoe, Victoria, Australia
HammondCare
🇦🇺Malvern, Victoria, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Local Institution - 0147
🇦🇺Parkville, Victoria, Australia
Alzheimer's Research Australia
🇦🇺Nedlands, Western Australia, Australia
Local Institution - 0122
🇧🇪Anderlecht, Brussels, Belgium
Antwerp University Hospital
🇧🇪Antwerpen, Brussel, Belgium
AZ Groeninge - Campus Kennedylaan
🇧🇪Kortrijk, VWV, Belgium
Local Institution - 0078
🇧🇪Liege, WLG, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
Ottawa Memory Clinic
🇨🇦Ottawa, Ontario, Canada
Toronto Memory Program
🇨🇦Toronto, Ontario, Canada
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
The Rotman Research Institute at Baycrest
🇨🇦Toronto, Ontario, Canada
MoCA Clinic & Institute (Memory Clinic)
🇨🇦Greenfield Park, Quebec, Canada
Local Institution - 0193
🇨🇦Montreal, Quebec, Canada
Genge Partners Inc
🇨🇦Montreal, Quebec, Canada
Local Institution - 0075
🇨🇦Montreal, Quebec, Canada
Alpha Recherche Clinique
🇨🇦Quebec, Canada
Local Institution - 0181
🇯🇵Nagoya-Shi, Aichi, Japan
Memory Clinic Toride
🇯🇵Toride-Shi, Ibaraki, Japan
Katayama Medical Clinic
🇯🇵Kurashiki-Shi, Okayama, Japan
Takatsuki General Hospital
🇯🇵Takatsuki-Shi, Japan
MI Clinic
🇯🇵Toyonaka-Shi, Japan
Local Institution - 0117
🇰🇷Songpa-gu, Seoul, Korea, Republic of
Konkuk University Medical Center (KUMC) - Dementia Clinic
🇰🇷Gwangjingu, Korea, Republic of
Gachon University - Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Local Institution - 0114
🇰🇷Junggu, Korea, Republic of
National University of Singapore's Yong Loo Lin School of Medicine (NUS Medicine)
🇸🇬Singapore, Singapore
Hospital Clinic de Barcelona (Hospital Clinic i Provincial) - Barnaclinic S.A.
🇪🇸Barcelona, B, Spain
Hospital Universitari General de Catalunya
🇪🇸Sant Cugat Del Vallès, CT, Spain
Hospital Universitario Santa Maria de Lerida
🇪🇸Lleida, L, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Skanes Universitetssjukhus - Malmo (Universitetssjukhuset MAS) - Minneskliniken
🇸🇪Malmo, M, Sweden
Local Institution - 0138
🇸🇪Uppsala, Uppsala Lan, Sweden
Local Institution - 0160
🇸🇪Huddinge, Sweden
Local Institution - 0244
🇬🇧Birmingham, BIR, United Kingdom
Local Institution - 0245
🇬🇧Bristol, BST, United Kingdom
Local Institution - 0237
🇬🇧Southampton, Hampshire, United Kingdom
Local Institution - 0230
🇬🇧Southampton, HAM, United Kingdom
Local Institution - 0103
🇬🇧Winchester, HAM, United Kingdom
Local Institution - 0121
🇬🇧Enfield, LND, United Kingdom
St Pancras Clinical Research (SPCR)
🇬🇧London, LND, United Kingdom
Local Institution - 0100
🇬🇧London, LND, United Kingdom
Local Institution - 0247
🇬🇧Bath, SOM, United Kingdom
Local Institution - 0090
🇬🇧Guildford, SRY, United Kingdom
Surrey and Borders NHS Foundation Trust Headquarters
🇬🇧Chertsey, Surrey, United Kingdom
Local Institution - 0127
🇬🇧Bristol, United Kingdom