Study to Evaluate the Efficacy, Safety, and Tolerability... | NCT06268886

Studies
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

Sponsor

Bristol-Myers Squibb

Status

Active, not recruiting

Last Update Posted

Jul 24, 2025Actual

Enrollment

310Estimated

Phase

Phase 2

Conditions

Alzheimer Disease, Early Onset

Interventions

BMS-986446
Placebo

Countries

United States
Australia
Belgium
Canada
Japan
Singapore
South Korea
Spain
Sweden
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2023-504840-32	Other Identifier	EU CTR
U1111-1290-3539	Registry Identifier	WHO

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2024Actual

Primary Completion Date

Mar 18, 2027Estimated

Completion Date

Mar 18, 2027Estimated

First Submitted Date

Feb 13, 2024

First Submission Date that Met QC Criteria

Feb 13, 2024

First Posted Date

Feb 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2025

Last Update Posted Date

Jul 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

310Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Placebo	Placebo Comparator	Other: Placebo
BMS-986446 Dose A	Experimental	Drug: BMS-986446
BMS-986446 Dose B	Experimental	Drug: BMS-986446

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BMS-986446	Drug	Specified dose on specified days	BMS-986446 Dose A BMS-986446 Dose B

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0068		Chandler	Arizona	85226-3732	United States
Local Institution - 0102

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

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

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

See Plan Description

Access Criteria

See Plan Description

URL

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

ID	Term
D000544	Alzheimer Disease
D019636	Neurodegenerative Diseases
D003704	Dementia
D001927	Brain Diseases

ID	Term
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies
D019965	Neurocognitive Disorders
D001523	Mental Disorders