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BMS-986446

Phase 2

Alzheimer Disease, Early Onset | Small molecule | Neurology |Bristol-Myers Squibb Company|Last Updated: Aug 21, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment310

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986446 · 4 trials · 4 indications

Phase 2 1Phase 1 3
NCT06268886Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's DiseaseAlzheimer Disease, Early Onset
ACTIVE NOT_RECRUITING310 Analytics
PHASE2ACTIVE NOT_RECRUITING
Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease
Alzheimer Disease, Early Onset
NCT06268886310
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Study Endpoints

Primary Endpoints

Change from baseline in brain tau deposition as measured by tau positron emission tomography (PET)
At week 76
Absolute bioavailability estimated from geometric mean ratio (GMR) of area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986446 after subcutaneous (SC) infusion
Up to approximately 5 months
Absolute bioavailability estimated from GMR of AUC(INF) of BMS-986446 after intravenous (IV) infusion
Up to approximately 5 months
Maximum observed concentration (Cmax)
Up to approximately 5 months
Time of maximum observed concentration (Tmax)
Up to approximately 5 months
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Up to approximately 5 months
Area under the serum concentration-time curve from time zero to 672 hours (AUC(0-672))
Up to approximately 5 months
AUC(INF)
Up to approximately 5 months
Half-life (T-HALF)
Up to approximately 5 months
Apparent total body clearance in SC administration (CLT/F)
Up to approximately 5 months
Total body clearance in IV infusion (CLT)
Up to approximately 5 months
Apparent volume of distribution of terminal phase in SC administration (Vz/F)
Up to approximately 5 months
Volume of distribution of terminal phase (VZ)
Up to approximately 5 months
Geometric Mean Ratio (GMR) of Maximum Observed Serum Concentration (Cmax) of BMS-986446 Administered IV versus SC
Up to approximately Day 85
GMR of Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of BMS-986446 Administered IV versus SC
Up to approximately Day 85
GMR of Area Under the Serum Concentration-time Curve From Time Zero to 672 Hours (AUC(0-672)) of BMS-986446 Administered IV versus SC
Up to approximately Day 85
Absolute Bioavailability (F) Estimated From GMR of AUC(INF) of BMS-986446 Administered as SC versus IV Infusion
Up to approximately Day 85
Incidence of adverse events (AEs)
Up to Day 85
Number of participants with vital sign abnormalities
Up to Day 85
Number of participants with electrocardiogram (ECG) abnormalities
Up to Day 85
Number of participants with physical examination abnormalities
Up to Day 85
Number of participants with body weight abnormalities
Up to Day 85
Number of participants with clinical laboratory abnormalities
Up to Day 85

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
BMS-986446 Dose AEXPERIMENTAL -
BMS-986446 Dose BEXPERIMENTAL -
Panel A1: BMS986446EXPERIMENTAL -
Panel A2: BMS986446EXPERIMENTAL -
Panel A3: BMS986446EXPERIMENTAL -
Panel B1: BMS986446EXPERIMENTAL -
Panel B2: BMS986446EXPERIMENTAL -
Panel C1: BMS986446EXPERIMENTAL -
Arm AEXPERIMENTAL -
Arm BEXPERIMENTAL -
BMS-986446EXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986446DRUGSpecified dose on specified days
PlaceboOTHERSpecified dose on specified days
BMS-986446 IVDRUGSpecified dose on specified days was administered intravenously (IV).
BMS-986446 SCDRUGSpecified dose on specified days was administered subcutaneously (SC).
AcetaminophenDRUGSpecified dose on specified days
LoratadineDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range50 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites176

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 ...

Countries:United StatesAustraliaBelgiumCanadaJapanSingaporeSouth KoreaSpainSwedenUnited Kingdom
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Recent Changes (Last 90 Days)

LOWAug 21, 2026NCT07780383NEW_TRIAL: changed
LOWAug 21, 2026NCT07780383NEW_TRIAL: changed

Frequently asked questions about BMS-986446

What is BMS-986446 used for?

BMS-986446 is an investigational small molecule being developed for Alzheimer's disease. It is being studied in early Alzheimer's disease, including early onset cases, and in healthy participants for safety and drug level evaluations. The drug is currently in Phase 2 clinical development for the Alzheimer's indication.

What does BMS-986446 target?

BMS-986446 is an anti-MTBR tau monoclonal antibody, meaning it targets the microtubule-binding region (MTBR) of tau protein. By binding to this region, the drug is designed to interfere with tau pathology, which is a hallmark of Alzheimer's disease. This mechanism is being evaluated in early Alzheimer's disease patients.

Who makes BMS-986446?

BMS-986446 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety, tolerability, and efficacy in healthy participants and in individuals with early Alzheimer's disease.

What phase is BMS-986446 in?

BMS-986446 is in Phase 2 clinical development for early Alzheimer's disease. The Phase 2 trial, NCT06268886, is active but not recruiting participants. The drug is also being studied in earlier Phase 1 trials, some of which have been completed, to assess safety and drug levels in healthy volunteers.

What clinical trials is BMS-986446 in?

BMS-986446 has been studied in several clinical trials. NCT06084598 and NCT06955741 are completed Phase 1 trials in healthy participants. NCT06268886 is an active Phase 2 trial in early Alzheimer's disease. NCT07780383 is a not yet recruiting Phase 1 trial in healthy adults and early Alzheimer's patients.

Is BMS-986446 the same as an anti-MTBR tau antibody?

Yes, BMS-986446 is described as an anti-MTBR tau monoclonal antibody. This means it is designed to bind to the microtubule-binding region of the tau protein. The drug is being evaluated for its potential to modify disease progression in early Alzheimer's disease.