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BMS-986446 for Alzheimer's Disease

Recruiting at 6 trial locations
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Overseen ByFirst line of the email MUST contain NCT # and Site #.
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Bristol-Myers Squibb
Disqualifiers: Neurological conditions, Psychiatric diagnosis, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate the drug levels, absolute bioavailability, safety, tolerability, and immunogenicity of single-Dose of BMS-986446 in healthy adults after single-dose administration, and participants with early Alzheimer's Disease after multiple dose administration

Who Is on the Research Team?

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for healthy adults who can receive a single dose of the study drug, and people with early Alzheimer's disease who can take multiple doses. Participants must generally be in good health or have early-stage Alzheimer's, as appropriate.

Inclusion Criteria

Participants must have a BMI of 18.0 to 35.0 kg/m2
For Parts A and B: Participants must be healthy as determined by medical history, Physical Examination (PE), neurological examination, vital signs, 12-lead ECG, Columbia Suicide-Severity Rating Scale (C-SSRS), and clinical laboratory evaluations
For Part C: Participants must have an Mini Mental State Examination (MMSE) score of ≥ 20 to 28 (inclusive)
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Exclusion Criteria

For Parts A and B: Participants must not have donated or lost 500 mL blood or more within 60 days prior to study intervention administration
For Part C: Participants must not have any current primary psychiatric diagnosis (eg, major depression, schizoaffective disorder or bipolar disorder) other than AD or symptoms (eg, hallucination or delusions)
Other protocol-defined Inclusion/Exclusion criteria apply
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single-dose administration of BMS-986446 in healthy adults and multiple doses in participants with early Alzheimer's Disease

Up to approximately 5 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • BMS-986446

Trial Overview

The study is testing a new drug called BMS-986446 to see how it behaves in the body, its safety, and if it causes immune reactions. Healthy adults get one dose; people with early Alzheimer's get several doses.

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Group I: Panel C1: BMS986446Experimental Treatment1 Intervention
Group II: Panel B2: BMS986446Experimental Treatment1 Intervention
Group III: Panel B1: BMS986446Experimental Treatment1 Intervention
Group IV: Panel A3: BMS986446Experimental Treatment1 Intervention
Group V: Panel A2: BMS986446Experimental Treatment1 Intervention
Group VI: Panel A1: BMS986446Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

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