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

NCT06268886 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: CN008-00032023-504840-32U1111-1290-3539
• Study Type: interventional
• Target: 310
• Locations: 10 countries
• Sites: 176

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.

Conditions

Alzheimer Disease, Early Onset

Keywords

Alzheimer Disease; BMS-986446; Neurodegenerative disease; Dementia; Brain Diseases; Anti-MTBR tau monoclonal antibody; TargetTau-1; Anti-tau therapy

Outcome Measures

Primary Outcomes (1)

• Change from baseline in brain tau deposition as measured by tau positron emission tomography (PET)

  At week 76

Secondary Outcomes (5)

• 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Other: Placebo

BMS-986446 Dose A

EXPERIMENTAL

Drug: BMS-986446

BMS-986446 Dose B

EXPERIMENTAL

Drug: BMS-986446

Interventions

BMS-986446 DRUG

Specified dose on specified days

BMS-986446 Dose A; BMS-986446 Dose B

Placebo OTHER

Specified dose on specified days

Placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (176)

Local Institution - 0068

Chandler, Arizona, 85226-3732, United States

Location

Local Institution - 0102

Gilbert, Arizona, 85297-0441, United States

Location

Local Institution - 0019

Phoenix, Arizona, 85004, United States

Location

Local Institution - 0018

Scottsdale, Arizona, 85253, United States

Location

Local Institution - 0026

Scottsdale, Arizona, 85258-4595, United States

Location

Local Institution - 0077

Tucson, Arizona, 85718-6522, United States

Location

Local Institution - 0038

Tucson, Arizona, 85718-6632, United States

Location

Local Institution - 0164

Encino, California, 91316-1511, United States

Location

Local Institution - 0139

Fullerton, California, 92835-1040, United States

Location

Local Institution - 0191

Irvine, California, 92614-9403, United States

Location

Local Institution - 0234

Long Beach, California, 90804-2128, United States

Location

Local Institution - 0142

Los Alamitos, California, 90720-3589, United States

Location

Local Institution - 0037

Napa, California, 94558-2415, United States

Location

Local Institution - 0209

Sacramento, California, 95816, United States

Location

Local Institution - 0052

San Francisco, California, 94143-2350, United States

Location

Local Institution - 0137

Santa Ana, California, 92705-8675, United States

Location

Local Institution - 0046

Sherman Oaks, California, 91403-2131, United States

Location

Local Institution - 0106

Danbury, Connecticut, 06810-4088, United States

Location

Local Institution - 0148

New Haven, Connecticut, 06510, United States

Location

Local Institution - 0056

New Haven, Connecticut, 06511-5249, United States

Location

Local Institution - 0153

Stamford, Connecticut, 06905-1206, United States

Location

Local Institution - 0022

Altamonte Springs, Florida, 32714-2436, United States

Location

Local Institution - 0048

Atlantis, Florida, 33462-6631, United States

Location

Local Institution - 0228

Boca Raton, Florida, 33428-2236, United States

Location

Local Institution - 0250

Boca Raton, Florida, 33487-3626, United States

Location

Local Institution - 0224

Bradenton, Florida, 34205, United States

Location

Local Institution - 0020

Clermont, Florida, 34711-5933, United States

Location

Local Institution - 0009

Daytona Beach, Florida, 32117-5532, United States

Location

Local Institution - 0213

Fort Myers, Florida, 33912-4302, United States

Location

Local Institution - 0059

Greenacres City, Florida, 33467, United States

Location

Local Institution - 0207

Hialeah, Florida, 33012-4170, United States

Location

Local Institution - 0212

Hialeah, Florida, 33015-5110, United States

Location

Local Institution - 0198

Hialeah, Florida, 33016-1814, United States

Location

Local Institution - 0151

Lady Lake, Florida, 32159, United States

Location

Local Institution - 0146

Lakeland, Florida, 33805-2208, United States

Location

Local Institution - 0192

Maitland, Florida, 32751-3320, United States

Location

Local Institution - 0143

Maitland, Florida, 32751, United States

Location

Local Institution - 0027

Merritt Island, Florida, 32952-3616, United States

Location

Local Institution - 0203

Miami, Florida, 33032, United States

Location

Local Institution - 0058

Miami, Florida, 33122-1335, United States

Location

Local Institution - 0034

Miami, Florida, 33125-4719, United States

Location

Local Institution - 0211

Miami, Florida, 33126, United States

Location

Local Institution - 0195

Miami, Florida, 33133-4231, United States

Location

Local Institution - 0014

Miami, Florida, 33135-2957, United States

Location

Local Institution - 0005

Miami, Florida, 33135-2968, United States

Location

Local Institution - 0208

Miami, Florida, 33135-4759, United States

Location

Local Institution - 0013

Miami, Florida, 33135, United States

Location

Local Institution - 0008

Miami, Florida, 33137-2706, United States

Location

Local Institution - 0199

Miami, Florida, 33144, United States

Location

Local Institution - 0206

Miami, Florida, 33155-4630, United States

Location

Local Institution - 0176

Miami, Florida, 33155-6540, United States

Location

Local Institution - 0071

Miami, Florida, 33166-2710, United States

Location

Local Institution - 0156

Miami, Florida, 33175-3598, United States

Location

Local Institution - 0249

Miami, Florida, 33176-2151, United States

Location

Local Institution - 0039

Miami, Florida, 33176-7947, United States

Location

Local Institution - 0225

Miami, Florida, 33176, United States

Location

Local Institution - 0197

Miami Springs, Florida, 33166-7225, United States

Location

Local Institution - 0217

Naples, Florida, 34105, United States

Location

Local Institution - 0017

New Port Richey, Florida, 34652-4020, United States

Location

Local Institution - 0144

Ocala, Florida, 34471, United States

Location

Local Institution - 0202

Orlando, Florida, 32806-8521, United States

Location

Local Institution - 0219

Orlando, Florida, 32807, United States

Location

Local Institution - 0035

Orlando, Florida, 32819-8031, United States

Location

Local Institution - 0238

Orlando, Florida, 32832, United States

Location

Local Institution - 0210

Port Orange, Florida, 32127-5170, United States

Location

Local Institution - 0204

Sarasota, Florida, 34239-3228, United States

Location

Local Institution - 0012

Stuart, Florida, 34997-5765, United States

Location

Local Institution - 0136

Stuart, Florida, 34997-6405, United States

Location

Local Institution - 0200

Tampa, Florida, 33607-6210, United States

Location

Local Institution - 0080

Tampa, Florida, 33607-6616, United States

Location

Local Institution - 0087

Tampa, Florida, 33609-4049, United States

Location

Local Institution - 0042

Tampa, Florida, 33613-4808, United States

Location

Local Institution - 0194

Viera, Florida, 32940-7948, United States

Location

Local Institution - 0011

Wellington, Florida, 33414-9320, United States

Location

Local Institution - 0223

West Palm Beach, Florida, 33407-3234, United States

Location

Local Institution - 0149

West Palm Beach, Florida, 33409-6611, United States

Location

Local Institution - 0029

Windermere, Florida, 34786-8919, United States

Location

Local Institution - 0101

Winter Park, Florida, 32789-1848, United States

Location

Local Institution - 0154

Winter Park, Florida, 32792, United States

Location

Local Institution - 0105

Columbus, Georgia, 31909-1692, United States

Location

Local Institution - 0236

Chicago, Illinois, 60611-2818, United States

Location

Local Institution - 0021

Chicago, Illinois, 60640-2831, United States

Location

Local Institution - 0161

Elk Grove Village, Illinois, 60007-3362, United States

Location

Local Institution - 0003

Gurnee, Illinois, 60031, United States

Location

Local Institution - 0145

Park Ridge, Illinois, 60068, United States

Location

Local Institution - 0081

Springfield, Illinois, 62702-4968, United States

Location

Local Institution - 0235

Boston, Massachusetts, 02116, United States

Location

Local Institution - 0025

Boston, Massachusetts, 02131-2515, United States

Location

Local Institution - 0015

Braintree, Massachusetts, 02184, United States

Location

Local Institution - 0174

Foxborough, Massachusetts, 02035-1309, United States

Location

Local Institution - 0118

Methuen, Massachusetts, 01844-5864, United States

Location

Local Institution - 0040

Newton, Massachusetts, 02459-3328, United States

Location

Local Institution - 0120

Plymouth, Massachusetts, 02360-7223, United States

Location

Local Institution - 0045

Watertown, Massachusetts, 02472-4153, United States

Location

Local Institution - 0119

Portsmouth, New Hampshire, 03801-6822, United States

Location

Local Institution - 0031

Princeton, New Jersey, 08540-2859, United States

Location

Local Institution - 0062

Toms River, New Jersey, 08755-5043, United States

Location

Local Institution - 0060

Albany, New York, 12208-3464, United States

Location

Local Institution - 0157

Amherst, New York, 14226-1727, United States

Location

Local Institution - 0061

Manhasset, New York, 11030-3816, United States

Location

Local Institution - 0205

New York, New York, 10029-5611, United States

Location

Local Institution - 0214

New York, New York, 10029-5611, United States

Location

Local Institution - 0104

New York, New York, 10029-6504, United States

Location

Local Institution - 0133

New York, New York, 10032-3726, United States

Location

Local Institution - 0043

Matthews, North Carolina, 28105-8336, United States

Location

Local Institution - 0215

Dayton, Ohio, 45459-4296, United States

Location

Local Institution - 0155

Independence, Ohio, 44131, United States

Location

Local Institution - 0023

Plymouth Meeting, Pennsylvania, 19462-7401, United States

Location

Local Institution - 0024

East Providence, Rhode Island, 02914, United States

Location

Local Institution - 0163

Providence, Rhode Island, 02906-4800, United States

Location

Local Institution - 0132

Cordova, Tennessee, 38018-4254, United States

Location

Local Institution - 0140

Franklin, Tennessee, 37067-5922, United States

Location

Local Institution - 0222

Nashville, Tennessee, 37212, United States

Location

Local Institution - 0069

Austin, Texas, 78757-8046, United States

Location

Local Institution - 0033

Beaumont, Texas, 77702, United States

Location

Local Institution - 0051

Dallas, Texas, 75231-4316, United States

Location

Local Institution - 0016

Houston, Texas, 77074-1812, United States

Location

Local Institution - 0196

Fairfax, Virginia, 22031-5216, United States

Location

Local Institution - 0168

Richmond, Virginia, 23294, United States

Location

Local Institution - 0111

East Gosford, New South Wales, 2250, Australia

Location

Local Institution - 0170

Macquarie Park, New South Wales, 2113, Australia

Location

Local Institution - 0116

Griffith University, Queensland, 4222, Australia

Location

Local Institution - 0115

Carlton North, Victoria, 3053, Australia

Location

Local Institution - 0093

Ivanhoe, Victoria, 3081, Australia

Location

Local Institution - 0001

Malvern, Victoria, 3144, Australia

Location

Local Institution - 0125

Melbourne, Victoria, 03181, Australia

Location

Local Institution - 0147

Parkville, Victoria, 3050, Australia

Location

Local Institution - 0094

Nedlands, Western Australia, 6009, Australia

Location

Local Institution - 0122

Anderlecht, Brussels Capital, 1070, Belgium

Location

Local Institution - 0175

Antwerpen, Brussels Capital, 2018, Belgium

Location

Local Institution - 0082

Kortrijk, VWV, 8500, Belgium

Location

Local Institution - 0097

Brussels, 1200, Belgium

Location

Local Institution - 0076

Leuven, 3000, Belgium

Location

Local Institution - 0112

Ottawa, Ontario, K1Z 8R7, Canada

Location

Local Institution - 0047

Toronto, Ontario, M3B 2S7, Canada

Location

Local Institution - 0044

Toronto, Ontario, M5T 2S8, Canada

Location

Local Institution - 0109

Toronto, Ontario, M6A 2E1, Canada

Location

Local Institution - 0113

Greenfield Park, Quebec, J4V 2J2, Canada

Location

Local Institution - 0248

Montreal, Quebec, H4A 3T2, Canada

Location

Local Institution - 0053

Québec, G3K 2P8, Canada

Location

Local Institution - 0181

Nagoya, Aichi-ken, 4570818, Japan

Location

Local Institution - 0227

Toride-Shi, Ibaraki, 302-0004, Japan

Location

Local Institution - 0186

Kurashiki-Shi, Okayama-ken, 710-0813, Japan

Location

Local Institution - 0242

Hirakata-Shi, Osaka, 573-1121, Japan

Location

Local Institution - 0253

Osaka, Osaka, 556-0015, Japan

Location

Local Institution - 0185

Bunkyo-Ku, Tokyo, 1130034, Japan

Location

Local Institution - 0218

Hachioji-Shi, Tokyo, 192-0071, Japan

Location

Local Institution - 0184

Setagaya-Ku, Tokyo, 1588531, Japan

Location

Local Institution - 0226

Chūōku, 104-0031, Japan

Location

Local Institution - 0190

Himeji-shi, 670-8560, Japan

Location

Local Institution - 0188

Kasukabe-Shi, 344-0036, Japan

Location

Local Institution - 0179

Kodaira-Shi, 187-8551, Japan

Location

Local Institution - 0221

Musashimurayama-Shi, 208-0022, Japan

Location

Local Institution - 0220

Musashino-shi, 180-8610, Japan

Location

Local Institution - 0180

Nagoya, 451-0052, Japan

Location

Local Institution - 0178

Osaka, 545-8586, Japan

Location

Local Institution - 0232

Ōbu, 474-8511, Japan

Location

Local Institution - 0240

Tachikawa-Shi, 190-0022, Japan

Location

Local Institution - 0239

Takatsuki-Shi, 569-1192, Japan

Location

Local Institution - 0189

Toyonaka-Shi, 560-0004, Japan

Location

Local Institution - 0091

Singapore, 119228, Singapore

Location

Local Institution - 0117

Songpa-gu, Seoul, 138-736, South Korea

Location

Local Institution - 0110

Gwangjingu, 143-729, South Korea

Location

Local Institution - 0050

Incheon, 21565, South Korea

Location

Local Institution - 0114

Junggu, 22332, South Korea

Location

Local Institution - 0158

Barcelona, B, 08036, Spain

Location

Local Institution - 0054

Sant Cugat del Vallès, CT, 08195, Spain

Location

Local Institution - 0231

Lleida, L, 25006, Spain

Location

Local Institution - 0096

Barcelona, 08003, Spain

Location

Local Institution - 0171

Barcelona, 08035, Spain

Location

Local Institution - 0172

Barcelona, 08041, Spain

Location

Local Institution - 0167

Malmo, M, 212 24, Sweden

Location

Local Institution - 0121

Enfield, LND, EN3 4GS, United Kingdom

Location

Local Institution - 0252

London, LND, EC2Y 8EA, United Kingdom

Location

Local Institution - 0247

Bath, SOM, BA1 3NG, United Kingdom

Location

Local Institution - 0089

Chertsey, Surrey, KT16 9AU, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Alzheimer Disease; Neurodegenerative Diseases; Dementia; Brain Diseases

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurocognitive Disorders; Mental Disorders

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 20, 2024
• Study Start: March 20, 2024
• Primary Completion (Estimated): March 18, 2027
• Study Completion (Estimated): March 18, 2027
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

CA (7); KR (4); US (119); SG (1); JP (20); ES (6); GB (4); AU (9); BE (5); SE (1)