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Alzheimer Disease, Early OnsetPhase 2TargetTau-1NCT06268886

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

A Phase 2 study testing BMS-986446 in people with Alzheimer Disease, Early Onset, run by Bristol-Myers Squibb at 176 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Alzheimer Disease, Early Onset
What is being tested?
BMS-986446
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
310 participants
Where
176 sitesin 10 countries
Study dates
20 Mar 2024to 17 Apr 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

176 sites in 10 countries.

176 sites in 10 countries

United States119 sites

  • Local Institution - 0060

    Albany, New York, 12208-3464

  • Local Institution - 0022

    Altamonte Springs, Florida, 32714-2436

  • Local Institution - 0157

    Amherst, New York, 14226-1727

  • Local Institution - 0048

    Atlantis, Florida, 33462-6631

  • Local Institution - 0069

    Austin, Texas, 78757-8046

  • Local Institution - 0033

    Beaumont, Texas, 77702

  • Local Institution - 0228

    Boca Raton, Florida, 33428-2236

  • Local Institution - 0250

    Boca Raton, Florida, 33487-3626

  • Local Institution - 0235

    Boston, Massachusetts, 02116

  • Local Institution - 0025

    Boston, Massachusetts, 02131-2515

  • Local Institution - 0224

    Bradenton, Florida, 34205

  • Local Institution - 0015

    Braintree, Massachusetts, 02184

  • Local Institution - 0068

    Chandler, Arizona, 85226-3732

  • Local Institution - 0236

    Chicago, Illinois, 60611-2818

  • Local Institution - 0021

    Chicago, Illinois, 60640-2831

  • Local Institution - 0020

    Clermont, Florida, 34711-5933

  • Local Institution - 0105

    Columbus, Georgia, 31909-1692

  • Local Institution - 0132

    Cordova, Tennessee, 38018-4254

  • Local Institution - 0051

    Dallas, Texas, 75231-4316

  • Local Institution - 0106

    Danbury, Connecticut, 06810-4088

  • Local Institution - 0215

    Dayton, Ohio, 45459-4296

  • Local Institution - 0009

    Daytona Beach, Florida, 32117-5532

  • Local Institution - 0024

    East Providence, Rhode Island, 02914

  • Local Institution - 0161

    Elk Grove Village, Illinois, 60007-3362

  • Local Institution - 0164

    Encino, California, 91316-1511

  • Local Institution - 0196

    Fairfax, Virginia, 22031-5216

  • Local Institution - 0213

    Fort Myers, Florida, 33912-4302

  • Local Institution - 0174

    Foxborough, Massachusetts, 02035-1309

  • Local Institution - 0140

    Franklin, Tennessee, 37067-5922

  • Local Institution - 0139

    Fullerton, California, 92835-1040

  • Local Institution - 0102

    Gilbert, Arizona, 85297-0441

  • Local Institution - 0059

    Greenacres City, Florida, 33467

  • Local Institution - 0003

    Gurnee, Illinois, 60031

  • Local Institution - 0207

    Hialeah, Florida, 33012-4170

  • Local Institution - 0212

    Hialeah, Florida, 33015-5110

  • Local Institution - 0198

    Hialeah, Florida, 33016-1814

  • Local Institution - 0016

    Houston, Texas, 77074-1812

  • Local Institution - 0155

    Independence, Ohio, 44131

  • Local Institution - 0191

    Irvine, California, 92614-9403

  • Local Institution - 0151

    Lady Lake, Florida, 32159

  • Local Institution - 0146

    Lakeland, Florida, 33805-2208

  • Local Institution - 0234

    Long Beach, California, 90804-2128

  • Local Institution - 0142

    Los Alamitos, California, 90720-3589

  • Local Institution - 0192

    Maitland, Florida, 32751-3320

  • Local Institution - 0143

    Maitland, Florida, 32751

  • Local Institution - 0061

    Manhasset, New York, 11030-3816

  • Local Institution - 0043

    Matthews, North Carolina, 28105-8336

  • Local Institution - 0027

    Merritt Island, Florida, 32952-3616

  • Local Institution - 0118

    Methuen, Massachusetts, 01844-5864

  • Local Institution - 0203

    Miami, Florida, 33032

  • Local Institution - 0058

    Miami, Florida, 33122-1335

  • Local Institution - 0034

    Miami, Florida, 33125-4719

  • Local Institution - 0211

    Miami, Florida, 33126

  • Local Institution - 0195

    Miami, Florida, 33133-4231

  • Local Institution - 0014

    Miami, Florida, 33135-2957

  • Local Institution - 0005

    Miami, Florida, 33135-2968

  • Local Institution - 0208

    Miami, Florida, 33135-4759

  • Local Institution - 0013

    Miami, Florida, 33135

  • Local Institution - 0008

    Miami, Florida, 33137-2706

  • Local Institution - 0199

    Miami, Florida, 33144

  • Local Institution - 0206

    Miami, Florida, 33155-4630

  • Local Institution - 0176

    Miami, Florida, 33155-6540

  • Local Institution - 0071

    Miami, Florida, 33166-2710

  • Local Institution - 0156

    Miami, Florida, 33175-3598

  • Local Institution - 0249

    Miami, Florida, 33176-2151

  • Local Institution - 0039

    Miami, Florida, 33176-7947

  • Local Institution - 0225

    Miami, Florida, 33176

  • Local Institution - 0197

    Miami Springs, Florida, 33166-7225

  • Local Institution - 0037

    Napa, California, 94558-2415

  • Local Institution - 0217

    Naples, Florida, 34105

  • Local Institution - 0222

    Nashville, Tennessee, 37212

  • Local Institution - 0148

    New Haven, Connecticut, 06510

  • Local Institution - 0056

    New Haven, Connecticut, 06511-5249

  • Local Institution - 0017

    New Port Richey, Florida, 34652-4020

  • Local Institution - 0205

    New York, New York, 10029-5611

  • Local Institution - 0214

    New York, New York, 10029-5611

  • Local Institution - 0104

    New York, New York, 10029-6504

  • Local Institution - 0133

    New York, New York, 10032-3726

  • Local Institution - 0040

    Newton, Massachusetts, 02459-3328

  • Local Institution - 0144

    Ocala, Florida, 34471

  • Local Institution - 0202

    Orlando, Florida, 32806-8521

  • Local Institution - 0219

    Orlando, Florida, 32807

  • Local Institution - 0035

    Orlando, Florida, 32819-8031

  • Local Institution - 0238

    Orlando, Florida, 32832

  • Local Institution - 0145

    Park Ridge, Illinois, 60068

  • Local Institution - 0019

    Phoenix, Arizona, 85004

  • Local Institution - 0120

    Plymouth, Massachusetts, 02360-7223

  • Local Institution - 0023

    Plymouth Meeting, Pennsylvania, 19462-7401

  • Local Institution - 0210

    Port Orange, Florida, 32127-5170

  • Local Institution - 0119

    Portsmouth, New Hampshire, 03801-6822

  • Local Institution - 0031

    Princeton, New Jersey, 08540-2859

  • Local Institution - 0163

    Providence, Rhode Island, 02906-4800

  • Local Institution - 0168

    Richmond, Virginia, 23294

  • Local Institution - 0209

    Sacramento, California, 95816

  • Local Institution - 0052

    San Francisco, California, 94143-2350

  • Local Institution - 0137

    Santa Ana, California, 92705-8675

  • Local Institution - 0204

    Sarasota, Florida, 34239-3228

  • Local Institution - 0018

    Scottsdale, Arizona, 85253

  • Local Institution - 0026

    Scottsdale, Arizona, 85258-4595

  • Local Institution - 0046

    Sherman Oaks, California, 91403-2131

  • Local Institution - 0081

    Springfield, Illinois, 62702-4968

  • Local Institution - 0153

    Stamford, Connecticut, 06905-1206

  • Local Institution - 0012

    Stuart, Florida, 34997-5765

  • Local Institution - 0136

    Stuart, Florida, 34997-6405

  • Local Institution - 0200

    Tampa, Florida, 33607-6210

  • Local Institution - 0080

    Tampa, Florida, 33607-6616

  • Local Institution - 0087

    Tampa, Florida, 33609-4049

  • Local Institution - 0042

    Tampa, Florida, 33613-4808

  • Local Institution - 0062

    Toms River, New Jersey, 08755-5043

  • Local Institution - 0077

    Tucson, Arizona, 85718-6522

  • Local Institution - 0038

    Tucson, Arizona, 85718-6632

  • Local Institution - 0194

    Viera, Florida, 32940-7948

  • Local Institution - 0045

    Watertown, Massachusetts, 02472-4153

  • Local Institution - 0011

    Wellington, Florida, 33414-9320

  • Local Institution - 0223

    West Palm Beach, Florida, 33407-3234

  • Local Institution - 0149

    West Palm Beach, Florida, 33409-6611

  • Local Institution - 0029

    Windermere, Florida, 34786-8919

  • Local Institution - 0101

    Winter Park, Florida, 32789-1848

  • Local Institution - 0154

    Winter Park, Florida, 32792

Other trials in United States

Japan20 sites

  • Local Institution - 0185

    Bunkyo-Ku, Tokyo, 1130034

  • Local Institution - 0226

    Chūōku, 104-0031

  • Local Institution - 0218

    Hachioji-Shi, Tokyo, 192-0071

  • Local Institution - 0190

    Himeji-shi, 670-8560

  • Local Institution - 0242

    Hirakata-Shi, Osaka, 573-1121

  • Local Institution - 0188

    Kasukabe-Shi, 344-0036

  • Local Institution - 0179

    Kodaira-Shi, 187-8551

  • Local Institution - 0186

    Kurashiki-Shi, Okayama-ken, 710-0813

  • Local Institution - 0221

    Musashimurayama-Shi, 208-0022

  • Local Institution - 0220

    Musashino-shi, 180-8610

  • Local Institution - 0181

    Nagoya, Aichi-ken, 4570818

  • Local Institution - 0180

    Nagoya, 451-0052

  • Local Institution - 0232

    Ōbu, 474-8511

  • Local Institution - 0253

    Osaka, Osaka, 556-0015

  • Local Institution - 0178

    Osaka, 545-8586

  • Local Institution - 0184

    Setagaya-Ku, Tokyo, 1588531

  • Local Institution - 0240

    Tachikawa-Shi, 190-0022

  • Local Institution - 0239

    Takatsuki-Shi, 569-1192

  • Local Institution - 0227

    Toride-Shi, Ibaraki, 302-0004

  • Local Institution - 0189

    Toyonaka-Shi, 560-0004

Other trials in Japan

Australia9 sites

  • Local Institution - 0115

    Carlton North, Victoria, 3053

  • Local Institution - 0111

    East Gosford, New South Wales, 2250

  • Local Institution - 0116

    Griffith University, Queensland, 4222

  • Local Institution - 0093

    Ivanhoe, Victoria, 3081

  • Local Institution - 0170

    Macquarie Park, New South Wales, 2113

  • Local Institution - 0001

    Malvern, Victoria, 3144

  • Local Institution - 0125

    Melbourne, Victoria, 03181

  • Local Institution - 0094

    Nedlands, Western Australia, 6009

  • Local Institution - 0147

    Parkville, Victoria, 3050

Other trials in Australia

Canada7 sites

  • Local Institution - 0113

    Greenfield Park, Quebec, J4V 2J2

  • Local Institution - 0248

    Montreal, Quebec, H4A 3T2

  • Local Institution - 0112

    Ottawa, Ontario, K1Z 8R7

  • Local Institution - 0053

    Québec, G3K 2P8

  • Local Institution - 0047

    Toronto, Ontario, M3B 2S7

  • Local Institution - 0044

    Toronto, Ontario, M5T 2S8

  • Local Institution - 0109

    Toronto, Ontario, M6A 2E1

Other trials in Canada

Spain6 sites

  • Local Institution - 0158

    Barcelona, B, 08036

  • Local Institution - 0096

    Barcelona, 08003

  • Local Institution - 0171

    Barcelona, 08035

  • Local Institution - 0172

    Barcelona, 08041

  • Local Institution - 0231

    Lleida, L, 25006

  • Local Institution - 0054

    Sant Cugat del Vallès, CT, 08195

Other trials in Spain

Belgium5 sites

  • Local Institution - 0122

    Anderlecht, Brussels Capital, 1070

  • Local Institution - 0175

    Antwerpen, Brussels Capital, 2018

  • Local Institution - 0097

    Brussels, 1200

  • Local Institution - 0082

    Kortrijk, VWV, 8500

  • Local Institution - 0076

    Leuven, 3000

Other trials in Belgium

South Korea4 sites

  • Local Institution - 0110

    Gwangjingu, 143-729

  • Local Institution - 0050

    Incheon, 21565

  • Local Institution - 0114

    Junggu, 22332

  • Local Institution - 0117

    Songpa-gu, Seoul, 138-736

Other trials in South Korea

United Kingdom4 sites

  • Local Institution - 0247

    Bath, SOM, BA1 3NG

  • Local Institution - 0089

    Chertsey, Surrey, KT16 9AU

  • Local Institution - 0121

    Enfield, LND, EN3 4GS

  • Local Institution - 0252

    London, LND, EC2Y 8EA

Other trials in United Kingdom

Singapore1 site

  • Local Institution - 0091

    Singapore, 119228

Other trials in Singapore

Sweden1 site

  • Local Institution - 0167

    Malmö, M, 212 24

Other trials in Sweden

About this study

Official title: 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.

Being tested
BMS-986446, Placebo
Keywords
Alzheimer Disease, BMS-986446, Neurodegenerative disease, Dementia, Brain Diseases, Anti-MTBR tau monoclonal antibody, TargetTau-1, Anti-tau therapy
Medical subject headings
Alzheimer Disease, Neurodegenerative Diseases, Dementia, Brain Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986446Drug

    Specified dose on specified days

  • PlaceboOther

    Specified dose on specified days

Study groups in NCT06268886
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo
BMS-986446 Dose AExperimentalNot described
Receives: Drug: BMS-986446
BMS-986446 Dose BExperimentalNot described
Receives: Drug: BMS-986446

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: At week 76

Secondary outcomes (5)

  1. Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score

    Measured: At week 76

  2. Change from baseline in Mini Mental State Examination (MMSE) score

    Measured: At week 76

  3. Change from baseline in integrated Alzheimer's Disease Rating Scale (iADRS) score

    Measured: At week 76

  4. Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADASCog14) score

    Measured: At week 76

  5. Change from baseline in Alzheimer's Disease Cooperative Study-instrumental Activities of Daily Living scale (ADCS-iADL) score

    Measured: At week 76

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2024
  2. Study start20 Mar 2024
  3. Primary completion17 Dec 2026 (estimated)
  4. Study completion17 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
310 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06268886
Sponsor's protocol ID
CN008-0003
Other IDs
2023-504840-32, U1111-1290-3539, 2023
Acronym
TargetTau-1
Status last verified
Oct 2026
First submitted
13 Feb 2024
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMS-986446 in people with Alzheimer Disease, Early Onset, run by Bristol-Myers Squibb at 176 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 176 sites in United States, Japan, Australia, Canada, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in brain tau deposition as measured by tau positron emission tomography (PET) (time frame: At week 76). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06268886.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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