A Study 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
About this study
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
- Condition
- Alzheimer's Disease, Healthy Participants
- Tested
- BMS-986446
- Sponsor
- Bristol-Myers Squibb
Who can join
- Age
- 18 to 80 years
- Sex
- All sexes
- Healthy volunteers
- Accepted
Inclusion 8
- Minimum age: 18 years
- Maximum age: 80 years
- Study condition: Alzheimer's Disease, Healthy Participants
- 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 5
- 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
6 sites, 6 recruiting
CenExel ACT (Formerly Anaheim Clinical Trials; LLC)
Anaheim, California, United States
Local Institution - 0003
Bradenton, Florida, United States
Local Institution - 0005
Daytona Beach, Florida, United States
Local Institution - 0004
Decatur, Georgia, United States
Local Institution - 0007
Naples, Florida, United States
Local Institution - 0006
The Villages, Florida, United States
Contact
-
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286 Clinical.Trials@bms.com
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First line of the email MUST contain NCT # and Site #.
Potential match only. Final eligibility is determined by the study team.