Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease (TargetTau-1)

A Randomized, Double-blind, Placebo-controlled, Global Proof-of-concept Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986446, an Anti-MTBR Tau Monoclonal Antibody, in Participants With Early Alzheimer's Disease (TargetTau-1)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alzheimer Disease, Early Onset
• Intervention / Treatment: Other: Placebo; Drug: BMS-986446

• Study Type: Interventional
• Enrollment (Estimated): 310
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • East Gosford, New South Wales, Australia, 2250
      • Local Institution - 0111
    • Macquarie Park, New South Wales, Australia, 2113
      • Local Institution - 0170
  • Queensland
    • Griffith University, Queensland, Australia, 4222
      • Local Institution - 0116
  • Victoria
    • Carlton North, Victoria, Australia, 3053
      • Local Institution - 0115
    • Ivanhoe, Victoria, Australia, 3081
      • Local Institution - 0093
    • Malvern, Victoria, Australia, 3144
      • Local Institution - 0001
    • Melbourne, Victoria, Australia, 03181
      • Local Institution - 0125
    • Parkville, Victoria, Australia, 3050
      • Local Institution - 0147
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Local Institution - 0094
• Belgium
  • Brussels, Belgium, 1200
    • Local Institution - 0097
  • Leuven, Belgium, 3000
    • Local Institution - 0076
  • Brussel
    • Antwerpen, Brussel, Belgium, 2018
      • Local Institution - 0175
  • Brussels
    • Anderlecht, Brussels, Belgium, 1070
      • Local Institution - 0122
  • VWV
    • Kortrijk, VWV, Belgium, 8500
      • Local Institution - 0082
• Canada
  • Quebec, Canada, G3K 2P8
    • Local Institution - 0053
  • Ontario
    • Ottawa, Ontario, Canada, K1Z 8R7
      • Local Institution - 0112
    • Toronto, Ontario, Canada, M3B 2S7
      • Local Institution - 0047
    • Toronto, Ontario, Canada, M5T 2S8
      • Local Institution - 0044
    • Toronto, Ontario, Canada, M6A 2E1
      • Local Institution - 0109
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2J2
      • Local Institution - 0113
    • Montreal, Quebec, Canada, H4A 3T2
      • Local Institution - 0248
• Japan
  • Chuo-Ku, Japan, 104-0031
    • Local Institution - 0226
  • Himeji-shi, Japan, 670-8560
    • Local Institution - 0190
  • Kasukabe-Shi, Japan, 344-0036
    • Local Institution - 0188
  • Kodaira-Shi, Japan, 187-8551
    • Local Institution - 0179
  • Musashimurayama-Shi, Japan, 208-0022
    • Local Institution - 0221
  • Musashino-shi, Japan, 180-8610
    • Local Institution - 0220
  • Nagoya-Shi, Japan, 451-0052
    • Local Institution - 0180
  • Obu, Japan, 474-8511
    • Local Institution - 0232
  • Osaka-shi, Japan, 545-8586
    • Local Institution - 0178
  • Tachikawa-Shi, Japan, 190-0022
    • Local Institution - 0240
  • Takatsuki-Shi, Japan, 569-1192
    • Local Institution - 0239
  • Toyonaka-Shi, Japan, 560-0004
    • Local Institution - 0189
  • Aichi
    • Nagoya-Shi, Aichi, Japan, 4570818
      • Local Institution - 0181
  • Ibaraki
    • Toride-Shi, Ibaraki, Japan, 302-0004
      • Local Institution - 0227
  • Okayama
    • Kurashiki-Shi, Okayama, Japan, 710-0813
      • Local Institution - 0186
  • Osaka
    • Hirakata-Shi, Osaka, Japan, 573-1121
      • Local Institution - 0242
    • Osaka-shi, Osaka, Japan, 556-0015
      • Local Institution - 0253
  • Tokyo
    • Bunkyo-Ku, Tokyo, Japan, 1130034
      • Local Institution - 0185
    • Hachioji-Shi, Tokyo, Japan, 192-0071
      • Local Institution - 0218
    • Setagaya-Ku, Tokyo, Japan, 1588531
      • Local Institution - 0184
• Korea, Republic of
  • Gwangjingu, Korea, Republic of, 143-729
    • Local Institution - 0110
  • Incheon, Korea, Republic of, 21565
    • Local Institution - 0050
  • Junggu, Korea, Republic of, 22332
    • Local Institution - 0114
  • Seoul
    • Songpa-gu, Seoul, Korea, Republic of, 138-736
      • Local Institution - 0117
• Singapore
  • Singapore, Singapore, 119228
    • Local Institution - 0091
• Spain
  • Barcelona, Spain, 08035
    • Local Institution - 0171
  • Barcelona, Spain, 08003
    • Local Institution - 0096
  • Barcelona, Spain, 08041
    • Local Institution - 0172
  • B
    • Barcelona, B, Spain, 08036
      • Local Institution - 0158
  • CT
    • Sant Cugat Del Vallès, CT, Spain, 08195
      • Local Institution - 0054
  • L
    • Lleida, L, Spain, 25006
      • Local Institution - 0231
• Sweden
  • M
    • Malmo, M, Sweden, 212 24
      • Local Institution - 0167
• United Kingdom
  • LND
    • Enfield, LND, United Kingdom, EN3 4GS
      • Local Institution - 0121
    • London, LND, United Kingdom, EC2Y 8EA
      • Local Institution - 0252
  • SOM
    • Bath, SOM, United Kingdom, BA1 3NG
      • Local Institution - 0247
  • Surrey
    • Chertsey, Surrey, United Kingdom, KT16 9AU
      • Local Institution - 0089
• United States
  • Arizona
    • Chandler, Arizona, United States, 85226-3732
      • Local Institution - 0068
    • Gilbert, Arizona, United States, 85297-0441
      • Local Institution - 0102
    • Phoenix, Arizona, United States, 85004
      • Local Institution - 0019
    • Scottsdale, Arizona, United States, 85253
      • Local Institution - 0018
    • Scottsdale, Arizona, United States, 85258-4595
      • Local Institution - 0026
    • Tucson, Arizona, United States, 85718-6522
      • Local Institution - 0077
    • Tucson, Arizona, United States, 85718-6632
      • Local Institution - 0038
  • California
    • Encino, California, United States, 91316-1511
      • Local Institution - 0164
    • Fullerton, California, United States, 92835-1040
      • Local Institution - 0139
    • Irvine, California, United States, 92614-9403
      • Local Institution - 0191
    • Long Beach, California, United States, 90804-2128
      • Local Institution - 0234
    • Los Alamitos, California, United States, 90720-3589
      • Local Institution - 0142
    • Napa, California, United States, 94558-2415
      • Local Institution - 0037
    • Sacramento, California, United States, 95816
      • Local Institution - 0209
    • San Francisco, California, United States, 94143-2350
      • Local Institution - 0052
    • Santa Ana, California, United States, 92705-8675
      • Local Institution - 0137
    • Sherman Oaks, California, United States, 91403-2131
      • Local Institution - 0046
  • Connecticut
    • Danbury, Connecticut, United States, 06810-4088
      • Local Institution - 0106
    • New Haven, Connecticut, United States, 06510
      • Local Institution - 0148
    • New Haven, Connecticut, United States, 06511-5249
      • Local Institution - 0056
    • Stamford, Connecticut, United States, 06905-1206
      • Local Institution - 0153
  • Florida
    • Altamonte Springs, Florida, United States, 32714-2436
      • Local Institution - 0022
    • Atlantis, Florida, United States, 33462-6631
      • Local Institution - 0048
    • Boca Raton, Florida, United States, 33428-2236
      • Local Institution - 0228
    • Boca Raton, Florida, United States, 33487-3626
      • Local Institution - 0250
    • Bradenton, Florida, United States, 34205
      • Local Institution - 0224
    • Clermont, Florida, United States, 34711-5933
      • Local Institution - 0020
    • Daytona Beach, Florida, United States, 32117-5532
      • Local Institution - 0009
    • Fort Myers, Florida, United States, 33912-4302
      • Local Institution - 0213
    • Greenacres City, Florida, United States, 33467
      • Local Institution - 0059
    • Hialeah, Florida, United States, 33012-4170
      • Local Institution - 0207
    • Hialeah, Florida, United States, 33015-5110
      • Local Institution - 0212
    • Hialeah, Florida, United States, 33016-1814
      • Local Institution - 0198
    • Lady Lake, Florida, United States, 32159
      • Local Institution - 0151
    • Lakeland, Florida, United States, 33805-2208
      • Local Institution - 0146
    • Maitland, Florida, United States, 32751
      • Local Institution - 0143
    • Maitland, Florida, United States, 32751-3320
      • Local Institution - 0192
    • Merritt Island, Florida, United States, 32952-3616
      • Local Institution - 0027
    • Miami, Florida, United States, 33175-3598
      • Local Institution - 0156
    • Miami, Florida, United States, 33032
      • Local Institution - 0203
    • Miami, Florida, United States, 33122-1335
      • Local Institution - 0058
    • Miami, Florida, United States, 33125-4719
      • Local Institution - 0034
    • Miami, Florida, United States, 33126
      • Local Institution - 0211
    • Miami, Florida, United States, 33133-4231
      • Local Institution - 0195
    • Miami, Florida, United States, 33135-2957
      • Local Institution - 0014
    • Miami, Florida, United States, 33135-2968
      • Local Institution - 0005
    • Miami, Florida, United States, 33135-4759
      • Local Institution - 0208
    • Miami, Florida, United States, 33135
      • Local Institution - 0013
    • Miami, Florida, United States, 33137-2706
      • Local Institution - 0008
    • Miami, Florida, United States, 33144
      • Local Institution - 0199
    • Miami, Florida, United States, 33155-4630
      • Local Institution - 0206
    • Miami, Florida, United States, 33155-6540
      • Local Institution - 0176
    • Miami, Florida, United States, 33166-2710
      • Local Institution - 0071
    • Miami, Florida, United States, 33176-2151
      • Local Institution - 0249
    • Miami, Florida, United States, 33176-7947
      • Local Institution - 0039
    • Miami, Florida, United States, 33176
      • Local Institution - 0225
    • Miami Springs, Florida, United States, 33166-7225
      • Local Institution - 0197
    • Naples, Florida, United States, 34105
      • Local Institution - 0217
    • New Port Richey, Florida, United States, 34652-4020
      • Local Institution - 0017
    • Ocala, Florida, United States, 34471
      • Local Institution - 0144
    • Orlando, Florida, United States, 32806-8521
      • Local Institution - 0202
    • Orlando, Florida, United States, 32807
      • Local Institution - 0219
    • Orlando, Florida, United States, 32819-8031
      • Local Institution - 0035
    • Orlando, Florida, United States, 32832
      • Local Institution - 0238
    • Port Orange, Florida, United States, 32127-5170
      • Local Institution - 0210
    • Sarasota, Florida, United States, 34239-3228
      • Local Institution - 0204
    • Stuart, Florida, United States, 34997-6405
      • Local Institution - 0136
    • Stuart, Florida, United States, 34997-5765
      • Local Institution - 0012
    • Tampa, Florida, United States, 33607-6210
      • Local Institution - 0200
    • Tampa, Florida, United States, 33607-6616
      • Local Institution - 0080
    • Tampa, Florida, United States, 33609-4049
      • Local Institution - 0087
    • Tampa, Florida, United States, 33613-4808
      • Local Institution - 0042
    • Viera, Florida, United States, 32940-7948
      • Local Institution - 0194
    • Wellington, Florida, United States, 33414-9320
      • Local Institution - 0011
    • West Palm Beach, Florida, United States, 33409-6611
      • Local Institution - 0149
    • West Palm Beach, Florida, United States, 33407-3234
      • Local Institution - 0223
    • Windermere, Florida, United States, 34786-8919
      • Local Institution - 0029
    • Winter Park, Florida, United States, 32792
      • Local Institution - 0154
    • Winter Park, Florida, United States, 32789-1848
      • Local Institution - 0101
  • Georgia
    • Columbus, Georgia, United States, 31909-1692
      • Local Institution - 0105
  • Illinois
    • Chicago, Illinois, United States, 60611-2818
      • Local Institution - 0236
    • Chicago, Illinois, United States, 60640-2831
      • Local Institution - 0021
    • Elk Grove Village, Illinois, United States, 60007-3362
      • Local Institution - 0161
    • Gurnee, Illinois, United States, 60031
      • Local Institution - 0003
    • Park Ridge, Illinois, United States, 60068
      • Local Institution - 0145
    • Springfield, Illinois, United States, 62702-4968
      • Local Institution - 0081
  • Massachusetts
    • Boston, Massachusetts, United States, 02116
      • Local Institution - 0235
    • Boston, Massachusetts, United States, 02131-2515
      • Local Institution - 0025
    • Braintree, Massachusetts, United States, 02184
      • Local Institution - 0015
    • Foxboro, Massachusetts, United States, 02035-1309
      • Local Institution - 0174
    • Methuen, Massachusetts, United States, 01844-5864
      • Local Institution - 0118
    • Newton, Massachusetts, United States, 02459-3328
      • Local Institution - 0040
    • Plymouth, Massachusetts, United States, 02360-7223
      • Local Institution - 0120
    • Watertown, Massachusetts, United States, 02472-4153
      • Local Institution - 0045
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801-6822
      • Local Institution - 0119
  • New Jersey
    • Princeton, New Jersey, United States, 08540-2859
      • Local Institution - 0031
    • Toms River, New Jersey, United States, 08755-5043
      • Local Institution - 0062
  • New York
    • Albany, New York, United States, 12208-3464
      • Local Institution - 0060
    • Amherst, New York, United States, 14226-1727
      • Local Institution - 0157
    • Manhasset, New York, United States, 11030-3816
      • Local Institution - 0061
    • New York, New York, United States, 10029-5611
      • Local Institution - 0205
    • New York, New York, United States, 10029-5611
      • Local Institution - 0214
    • New York, New York, United States, 10029-6504
      • Local Institution - 0104
    • New York, New York, United States, 10032-3726
      • Local Institution - 0133
  • North Carolina
    • Matthews, North Carolina, United States, 28105-8336
      • Local Institution - 0043
  • Ohio
    • Dayton, Ohio, United States, 45459-4296
      • Local Institution - 0215
    • Independence, Ohio, United States, 44131
      • Local Institution - 0155
  • Pennsylvania
    • Plymouth Meeting, Pennsylvania, United States, 19462-7401
      • Local Institution - 0023
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Local Institution - 0024
    • Providence, Rhode Island, United States, 02906-4800
      • Local Institution - 0163
  • Tennessee
    • Cordova, Tennessee, United States, 38018-4254
      • Local Institution - 0132
    • Franklin, Tennessee, United States, 37067-5922
      • Local Institution - 0140
    • Nashville, Tennessee, United States, 37212
      • Local Institution - 0222
  • Texas
    • Austin, Texas, United States, 78757-8046
      • Local Institution - 0069
    • Beaumont, Texas, United States, 77702
      • Local Institution - 0033
    • Dallas, Texas, United States, 75231-4316
      • Local Institution - 0051
    • Houston, Texas, United States, 77074-1812
      • Local Institution - 0016
  • Virginia
    • Fairfax, Virginia, United States, 22031-5216
      • Local Institution - 0196
    • Richmond, Virginia, United States, 23294
      • Local Institution - 0168

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Specified dose on specified days
Experimental: BMS-986446 Dose A	Drug: BMS-986446; Specified dose on specified days
Experimental: BMS-986446 Dose B	Drug: BMS-986446; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in brain tau deposition as measured by tau positron emission tomography (PET)	At week 76

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADASCog14) score	At week 76
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Estimated): March 18, 2027
• Study Completion (Estimated): March 18, 2027

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Dementia; Alzheimer Disease; Brain Diseases; Neurodegenerative disease; BMS-986446; Anti-MTBR tau monoclonal antibody; TargetTau-1; Anti-tau therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: CN008-0003; U1111-1290-3539 (Registry Identifier: WHO); 2023-504840-32 (Other Identifier: EU CTR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.

Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at:

https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No