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 — Phase 2, Active not recruiting, 310 participants, Bristol-Myers Squibb
ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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)

RegistryNCT06268886, acronym TargetTau-1
StatusActive not recruiting
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment310 (Estimated)
SponsorBristol-Myers Squibb (Industry)
ConditionsAlzheimer Disease, Early Onset
InterventionsBMS-986446, Placebo (Drug, other)
Datesstart 2024-03-20, primary completion 2027-03-18 (estimated), completion 2027-03-18 (estimated), first posted 2024-02-20, last updated 2025-07-24
Locations176 sites in United States, Australia, Belgium, Canada, Japan, Singapore, South Korea, Spain and 2 more countries

Related Papers Related Patents Related Grants Related Experts
All trials for Alzheimer Disease, Early Onset All trials of BMS-986446 All trials of Placebo

-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.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
PlaceboPlacebo comparatorOther: Placebo
BMS-986446 Dose AExperimentalDrug: BMS-986446
BMS-986446 Dose BExperimentalDrug: BMS-986446
  • BMS-986446 (Drug): Specified dose on specified days
  • Placebo (Other): Specified dose on specified days

+Outcome measures

Primary outcomes

  • Change from baseline in brain tau deposition as measured by tau positron emission tomography (PET) [At week 76]

Secondary outcomes

  • 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]

+Eligibility

Sex: All, ages: 50 Years to 80 Years

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.

+Locations (176)

FacilityCityCountryStatus
Local Institution - 0068Chandler, ArizonaUnited States
Local Institution - 0102Gilbert, ArizonaUnited States
Local Institution - 0019Phoenix, ArizonaUnited States
Local Institution - 0018Scottsdale, ArizonaUnited States
Local Institution - 0026Scottsdale, ArizonaUnited States
Local Institution - 0077Tucson, ArizonaUnited States
Local Institution - 0038Tucson, ArizonaUnited States
Local Institution - 0164Encino, CaliforniaUnited States
Local Institution - 0139Fullerton, CaliforniaUnited States
Local Institution - 0191Irvine, CaliforniaUnited States
Local Institution - 0234Long Beach, CaliforniaUnited States
Local Institution - 0142Los Alamitos, CaliforniaUnited States
Local Institution - 0037Napa, CaliforniaUnited States
Local Institution - 0209Sacramento, CaliforniaUnited States
Local Institution - 0052San Francisco, CaliforniaUnited States
Local Institution - 0137Santa Ana, CaliforniaUnited States
Local Institution - 0046Sherman Oaks, CaliforniaUnited States
Local Institution - 0106Danbury, ConnecticutUnited States
Local Institution - 0148New Haven, ConnecticutUnited States
Local Institution - 0056New Haven, ConnecticutUnited States
Local Institution - 0153Stamford, ConnecticutUnited States
Local Institution - 0022Altamonte Springs, FloridaUnited States
Local Institution - 0048Atlantis, FloridaUnited States
Local Institution - 0228Boca Raton, FloridaUnited States
Local Institution - 0250Boca Raton, FloridaUnited States
Local Institution - 0224Bradenton, FloridaUnited States
Local Institution - 0020Clermont, FloridaUnited States
Local Institution - 0009Daytona Beach, FloridaUnited States
Local Institution - 0213Fort Myers, FloridaUnited States
Local Institution - 0059Greenacres City, FloridaUnited States
Local Institution - 0207Hialeah, FloridaUnited States
Local Institution - 0212Hialeah, FloridaUnited States
Local Institution - 0198Hialeah, FloridaUnited States
Local Institution - 0151Lady Lake, FloridaUnited States
Local Institution - 0146Lakeland, FloridaUnited States
Local Institution - 0192Maitland, FloridaUnited States
Local Institution - 0143Maitland, FloridaUnited States
Local Institution - 0027Merritt Island, FloridaUnited States
Local Institution - 0203Miami, FloridaUnited States
Local Institution - 0058Miami, FloridaUnited States
Local Institution - 0034Miami, FloridaUnited States
Local Institution - 0211Miami, FloridaUnited States
Local Institution - 0195Miami, FloridaUnited States
Local Institution - 0014Miami, FloridaUnited States
Local Institution - 0005Miami, FloridaUnited States
Local Institution - 0208Miami, FloridaUnited States
Local Institution - 0013Miami, FloridaUnited States
Local Institution - 0008Miami, FloridaUnited States
Local Institution - 0199Miami, FloridaUnited States
Local Institution - 0206Miami, FloridaUnited States
Local Institution - 0176Miami, FloridaUnited States
Local Institution - 0071Miami, FloridaUnited States
Local Institution - 0156Miami, FloridaUnited States
Local Institution - 0249Miami, FloridaUnited States
Local Institution - 0039Miami, FloridaUnited States
Local Institution - 0225Miami, FloridaUnited States
Local Institution - 0197Miami Springs, FloridaUnited States
Local Institution - 0217Naples, FloridaUnited States
Local Institution - 0017New Port Richey, FloridaUnited States
Local Institution - 0144Ocala, FloridaUnited States
Local Institution - 0202Orlando, FloridaUnited States
Local Institution - 0219Orlando, FloridaUnited States
Local Institution - 0035Orlando, FloridaUnited States
Local Institution - 0238Orlando, FloridaUnited States
Local Institution - 0210Port Orange, FloridaUnited States
Local Institution - 0204Sarasota, FloridaUnited States
Local Institution - 0012Stuart, FloridaUnited States
Local Institution - 0136Stuart, FloridaUnited States
Local Institution - 0200Tampa, FloridaUnited States
Local Institution - 0080Tampa, FloridaUnited States
Local Institution - 0087Tampa, FloridaUnited States
Local Institution - 0042Tampa, FloridaUnited States
Local Institution - 0194Viera, FloridaUnited States
Local Institution - 0011Wellington, FloridaUnited States
Local Institution - 0223West Palm Beach, FloridaUnited States
Local Institution - 0149West Palm Beach, FloridaUnited States
Local Institution - 0029Windermere, FloridaUnited States
Local Institution - 0101Winter Park, FloridaUnited States
Local Institution - 0154Winter Park, FloridaUnited States
Local Institution - 0105Columbus, GeorgiaUnited States
Local Institution - 0236Chicago, IllinoisUnited States
Local Institution - 0021Chicago, IllinoisUnited States
Local Institution - 0161Elk Grove Village, IllinoisUnited States
Local Institution - 0003Gurnee, IllinoisUnited States
Local Institution - 0145Park Ridge, IllinoisUnited States
Local Institution - 0081Springfield, IllinoisUnited States
Local Institution - 0235Boston, MassachusettsUnited States
Local Institution - 0025Boston, MassachusettsUnited States
Local Institution - 0015Braintree, MassachusettsUnited States
Local Institution - 0174Foxborough, MassachusettsUnited States
Local Institution - 0118Methuen, MassachusettsUnited States
Local Institution - 0040Newton, MassachusettsUnited States
Local Institution - 0120Plymouth, MassachusettsUnited States
Local Institution - 0045Watertown, MassachusettsUnited States
Local Institution - 0119Portsmouth, New HampshireUnited States
Local Institution - 0031Princeton, New JerseyUnited States
Local Institution - 0062Toms River, New JerseyUnited States
Local Institution - 0060Albany, New YorkUnited States
Local Institution - 0157Amherst, New YorkUnited States
Local Institution - 0061Manhasset, New YorkUnited States

76 more sites not listed.

+Investigators

  • Bristol-Myers Squibb, Study director, Bristol-Myers Squibb

+Funding

NIH grants: 2023