Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease
NCT ID: NCT06268886
Last Updated: 2025-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
310 participants
INTERVENTIONAL
2024-03-20
2027-03-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Specified dose on specified days
BMS-986446 Dose A
BMS-986446
Specified dose on specified days
BMS-986446 Dose B
BMS-986446
Specified dose on specified days
Interventions
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BMS-986446
Specified dose on specified days
Placebo
Specified dose on specified days
Eligibility Criteria
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Inclusion 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
* 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.
50 Years
80 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0068
Chandler, Arizona, United States
Local Institution - 0102
Gilbert, Arizona, United States
Local Institution - 0019
Phoenix, Arizona, United States
Local Institution - 0018
Scottsdale, Arizona, United States
Local Institution - 0026
Scottsdale, Arizona, United States
Local Institution - 0077
Tucson, Arizona, United States
Local Institution - 0038
Tucson, Arizona, United States
Local Institution - 0164
Encino, California, United States
Local Institution - 0139
Fullerton, California, United States
Local Institution - 0191
Irvine, California, United States
Local Institution - 0234
Long Beach, California, United States
Local Institution - 0142
Los Alamitos, California, United States
Local Institution - 0037
Napa, California, United States
Local Institution - 0209
Sacramento, California, United States
Local Institution - 0052
San Francisco, California, United States
Local Institution - 0137
Santa Ana, California, United States
Local Institution - 0046
Sherman Oaks, California, United States
Local Institution - 0106
Danbury, Connecticut, United States
Local Institution - 0148
New Haven, Connecticut, United States
Local Institution - 0056
New Haven, Connecticut, United States
Local Institution - 0153
Stamford, Connecticut, United States
Local Institution - 0022
Altamonte Springs, Florida, United States
Local Institution - 0048
Atlantis, Florida, United States
Local Institution - 0228
Boca Raton, Florida, United States
Local Institution - 0250
Boca Raton, Florida, United States
Local Institution - 0224
Bradenton, Florida, United States
Local Institution - 0020
Clermont, Florida, United States
Local Institution - 0009
Daytona Beach, Florida, United States
Local Institution - 0213
Fort Myers, Florida, United States
Local Institution - 0059
Greenacres City, Florida, United States
Local Institution - 0207
Hialeah, Florida, United States
Local Institution - 0212
Hialeah, Florida, United States
Local Institution - 0198
Hialeah, Florida, United States
Local Institution - 0151
Lady Lake, Florida, United States
Local Institution - 0146
Lakeland, Florida, United States
Local Institution - 0192
Maitland, Florida, United States
Local Institution - 0143
Maitland, Florida, United States
Local Institution - 0027
Merritt Island, Florida, United States
Local Institution - 0203
Miami, Florida, United States
Local Institution - 0058
Miami, Florida, United States
Local Institution - 0034
Miami, Florida, United States
Local Institution - 0211
Miami, Florida, United States
Local Institution - 0195
Miami, Florida, United States
Local Institution - 0014
Miami, Florida, United States
Local Institution - 0005
Miami, Florida, United States
Local Institution - 0208
Miami, Florida, United States
Local Institution - 0013
Miami, Florida, United States
Local Institution - 0008
Miami, Florida, United States
Local Institution - 0199
Miami, Florida, United States
Local Institution - 0206
Miami, Florida, United States
Local Institution - 0176
Miami, Florida, United States
Local Institution - 0071
Miami, Florida, United States
Local Institution - 0156
Miami, Florida, United States
Local Institution - 0249
Miami, Florida, United States
Local Institution - 0039
Miami, Florida, United States
Local Institution - 0225
Miami, Florida, United States
Local Institution - 0197
Miami Springs, Florida, United States
Local Institution - 0217
Naples, Florida, United States
Local Institution - 0017
New Port Richey, Florida, United States
Local Institution - 0144
Ocala, Florida, United States
Local Institution - 0202
Orlando, Florida, United States
Local Institution - 0219
Orlando, Florida, United States
Local Institution - 0035
Orlando, Florida, United States
Local Institution - 0238
Orlando, Florida, United States
Local Institution - 0210
Port Orange, Florida, United States
Local Institution - 0204
Sarasota, Florida, United States
Local Institution - 0012
Stuart, Florida, United States
Local Institution - 0136
Stuart, Florida, United States
Local Institution - 0200
Tampa, Florida, United States
Local Institution - 0080
Tampa, Florida, United States
Local Institution - 0087
Tampa, Florida, United States
Local Institution - 0042
Tampa, Florida, United States
Local Institution - 0194
Viera, Florida, United States
Local Institution - 0011
Wellington, Florida, United States
Local Institution - 0223
West Palm Beach, Florida, United States
Local Institution - 0149
West Palm Beach, Florida, United States
Local Institution - 0029
Windermere, Florida, United States
Local Institution - 0101
Winter Park, Florida, United States
Local Institution - 0154
Winter Park, Florida, United States
Local Institution - 0105
Columbus, Georgia, United States
Local Institution - 0236
Chicago, Illinois, United States
Local Institution - 0021
Chicago, Illinois, United States
Local Institution - 0161
Elk Grove Village, Illinois, United States
Local Institution - 0003
Gurnee, Illinois, United States
Local Institution - 0145
Park Ridge, Illinois, United States
Local Institution - 0081
Springfield, Illinois, United States
Local Institution - 0235
Boston, Massachusetts, United States
Local Institution - 0025
Boston, Massachusetts, United States
Local Institution - 0015
Braintree, Massachusetts, United States
Local Institution - 0174
Foxborough, Massachusetts, United States
Local Institution - 0118
Methuen, Massachusetts, United States
Local Institution - 0040
Newton, Massachusetts, United States
Local Institution - 0120
Plymouth, Massachusetts, United States
Local Institution - 0045
Watertown, Massachusetts, United States
Local Institution - 0119
Portsmouth, New Hampshire, United States
Local Institution - 0031
Princeton, New Jersey, United States
Local Institution - 0062
Toms River, New Jersey, United States
Local Institution - 0060
Albany, New York, United States
Local Institution - 0157
Amherst, New York, United States
Local Institution - 0061
Manhasset, New York, United States
Local Institution - 0205
New York, New York, United States
Local Institution - 0214
New York, New York, United States
Local Institution - 0104
New York, New York, United States
Local Institution - 0133
New York, New York, United States
Local Institution - 0043
Matthews, North Carolina, United States
Local Institution - 0215
Dayton, Ohio, United States
Local Institution - 0155
Independence, Ohio, United States
Local Institution - 0023
Plymouth Meeting, Pennsylvania, United States
Local Institution - 0024
East Providence, Rhode Island, United States
Local Institution - 0163
Providence, Rhode Island, United States
Local Institution - 0132
Cordova, Tennessee, United States
Local Institution - 0140
Franklin, Tennessee, United States
Local Institution - 0222
Nashville, Tennessee, United States
Local Institution - 0069
Austin, Texas, United States
Local Institution - 0033
Beaumont, Texas, United States
Local Institution - 0051
Dallas, Texas, United States
Local Institution - 0016
Houston, Texas, United States
Local Institution - 0196
Fairfax, Virginia, United States
Local Institution - 0168
Richmond, Virginia, United States
Local Institution - 0111
East Gosford, New South Wales, Australia
Local Institution - 0170
Macquarie Park, New South Wales, Australia
Local Institution - 0116
Griffith University, Queensland, Australia
Local Institution - 0115
Carlton North, Victoria, Australia
Local Institution - 0093
Ivanhoe, Victoria, Australia
Local Institution - 0001
Malvern, Victoria, Australia
Local Institution - 0125
Melbourne, Victoria, Australia
Local Institution - 0147
Parkville, Victoria, Australia
Local Institution - 0094
Nedlands, Western Australia, Australia
Local Institution - 0122
Anderlecht, Brussels Capital, Belgium
Local Institution - 0175
Antwerpen, Brussels Capital, Belgium
Local Institution - 0082
Kortrijk, VWV, Belgium
Local Institution - 0097
Brussels, , Belgium
Local Institution - 0076
Leuven, , Belgium
Local Institution - 0112
Ottawa, Ontario, Canada
Local Institution - 0047
Toronto, Ontario, Canada
Local Institution - 0044
Toronto, Ontario, Canada
Local Institution - 0109
Toronto, Ontario, Canada
Local Institution - 0113
Greenfield Park, Quebec, Canada
Local Institution - 0248
Montreal, Quebec, Canada
Local Institution - 0053
Québec, , Canada
Local Institution - 0181
Nagoya, Aichi-ken, Japan
Local Institution - 0227
Toride-Shi, Ibaraki, Japan
Local Institution - 0186
Kurashiki-Shi, Okayama-ken, Japan
Local Institution - 0242
Hirakata-Shi, Osaka, Japan
Local Institution - 0253
Osaka, Osaka, Japan
Local Institution - 0185
Bunkyo-Ku, Tokyo, Japan
Local Institution - 0218
Hachioji-Shi, Tokyo, Japan
Local Institution - 0184
Setagaya-Ku, Tokyo, Japan
Local Institution - 0226
Chūōku, , Japan
Local Institution - 0190
Himeji-shi, , Japan
Local Institution - 0188
Kasukabe-Shi, , Japan
Local Institution - 0179
Kodaira-Shi, , Japan
Local Institution - 0221
Musashimurayama-Shi, , Japan
Local Institution - 0220
Musashino-shi, , Japan
Local Institution - 0180
Nagoya, , Japan
Local Institution - 0178
Osaka, , Japan
Local Institution - 0232
Ōbu, , Japan
Local Institution - 0240
Tachikawa-Shi, , Japan
Local Institution - 0239
Takatsuki-Shi, , Japan
Local Institution - 0189
Toyonaka-Shi, , Japan
Local Institution - 0091
Singapore, , Singapore
Local Institution - 0117
Songpa-gu, Seoul, South Korea
Local Institution - 0110
Gwangjingu, , South Korea
Local Institution - 0050
Incheon, , South Korea
Local Institution - 0114
Junggu, , South Korea
Local Institution - 0158
Barcelona, B, Spain
Local Institution - 0054
Sant Cugat del Vallès, CT, Spain
Local Institution - 0231
Lleida, L, Spain
Local Institution - 0096
Barcelona, , Spain
Local Institution - 0171
Barcelona, , Spain
Local Institution - 0172
Barcelona, , Spain
Local Institution - 0167
Malmo, M, Sweden
Local Institution - 0121
Enfield, LND, United Kingdom
Local Institution - 0252
London, LND, United Kingdom
Local Institution - 0247
Bath, SOM, United Kingdom
Local Institution - 0089
Chertsey, Surrey, United Kingdom
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2023-504840-32
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1290-3539
Identifier Type: REGISTRY
Identifier Source: secondary_id
CN008-0003
Identifier Type: -
Identifier Source: org_study_id
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