Effect of a single dose of BMS-986446 in healthy adults and after multiple doses in people with early Alzheimer's

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase study investigates the pharmacokinetics, absolute bioavailability, safety, tolerability, and immunogenicity of BMS-986446. Part A and B enroll healthy adults to receive a single dose, while Part C enrolls individuals with mild cognitive impairment or mild Alzheimer’s disease to receive multiple doses. The study includes comprehensive screening, safety assessments, and biomarker criteria such as MMSE and plasma pTau217, to evaluate whether the drug can be studied further in this population. Participants must meet specific BMI ranges and have no significant comorbid conditions, with Part C requiring cognitive impairment criteria per NIA-AA guidelines. Overall, the trial aims to characterize drug exposure, safety, and potential disease interactions in a controlled, early-stage setting.

Why it matters

Who can join: the full rules

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 meet diagnostic criteria for MCI or mild AD dementia, consistent with the National Institute on Aging and the Alzheimer's Association (NIA-AA) diagnostic criteria.
* For Part C: Participants must have an Mini Mental State Examination (MMSE) score of ≥ 20 to 28 (inclusive).
* For Part C: Participants must have evidence of positive plasma pTau217.

Exclusion Criteria

* For Parts A and B: Participants must not have a general history of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, immune-mediated disorder, hematological, ongoing allergic disorder requiring treatment, metabolic disorder, cancer, or cirrhosis.
* 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 a neurological condition that in the opinion of the investigator may be contributing to cognitive impairment aside from the AD diagnosis, including but not limited to: Parkinson's disease, vascular dementia, dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, long COVID, or baseline intellectual disability.
* 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.

Where it's running

• CenExel ACT (Formerly Anaheim Clinical Trials; LLC)
  Anaheim, California, United States Recruiting
• Local Institution - 0003
  Bradenton, Florida, United States Not yet recruiting
• Local Institution - 0005
  Daytona Beach, Florida, United States Not yet recruiting
• Local Institution - 0007
  Naples, Florida, United States Not yet recruiting
• Local Institution - 0006
  The Villages, Florida, United States Not yet recruiting
• Local Institution - 0004
  Decatur, Georgia, United States Not yet recruiting

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.