NCT06268886Active, not recruitingPhase 2
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)
Bristol-Myers Squibb176 sites in 1 country310 target enrollmentStarted: March 20, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 310
- Locations
- 176
- Primary Endpoint
- Change from baseline in brain tau deposition as measured by tau positron emission tomography (PET)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
Placebo Comparator
Intervention: Placebo (Other)
BMS-986446 Dose A
Experimental
Intervention: BMS-986446 (Drug)
BMS-986446 Dose B
Experimental
Intervention: BMS-986446 (Drug)
Outcomes
Primary Outcomes
Change from baseline in brain tau deposition as measured by tau positron emission tomography (PET)
Time Frame: 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)
Investigators
Study Sites (176)
Loading locations...
Similar Trials
Completed
Phase 2
A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic DermatitisDermatitis, AtopicNCT05014438Bristol-Myers Squibb17
Completed
Phase 1
A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986446 in Healthy Participants and Healthy Participants of Japanese EthnicityHealthy ParticipantsNCT06084598Bristol-Myers Squibb24
Active, not recruiting
Phase 3
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisNCT06003426Bristol-Myers Squibb1,255
Active, not recruiting
Phase 3
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary FibrosisProgressive Pulmonary FibrosisNCT06025578Bristol-Myers Squibb1,057
Completed
Phase 1
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986263 in Healthy ParticipantsFibrosisNCT03142165Bristol-Myers Squibb33