Actively Recruiting
BnH-015B Clinical Trial in Moderate Alzheimer's Disease
Led by BnH Research · Updated on 2025-01-07
92
Participants Needed
1
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
BnH-015B is a small molecule compound that targets the GluN2B binding site on NMDA receptors and positively modulates. BnH-015B has shown, through nonclinical trials, to improve symptoms of cognitive decline by regulating the BDNF/TRKβ and microglia-mediated IL-33/OPN signaling pathways; therefore, it is expected to be a promising new drug that can significantly improve symptoms associated with Alzheimer's disease, including memory loss.
CONDITIONS
Official Title
BnH-015B Clinical Trial in Moderate Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Part I: Healthy Korean or Caucasian male volunteers aged 19 to 45 at screening
- Part II: Individuals aged 55 to 85 years at informed consent
- Part II: Probable Alzheimer's disease dementia diagnosis per NIA-AA guidelines with MMSE 10-19 and CDR-Global Score 2
- Part II: Positive for P-tau181 and osteopontin in serum and amyloid positive by amyloid PET
- Part II: Diagnosed with Alzheimer's within 5 years prior to screening
- Part II: Consent signed by participant or legal representative; caregiver available throughout study
- Part II: Sufficient vision, hearing, language, motor function, and understanding to follow procedures
- Parts I & II: Weight between 55.0 kg and 90.0 kg and BMI of 18.0 to 30.0 kg/m2 at screening
- Parts I & II: Fully informed and voluntarily agree to participate
- Parts I & II: Suitable for study as determined by physical exams, lab tests, and medical history
You will not qualify if you...
- Part II: History of unstable angina, myocardial infarction, advanced chronic heart failure, or significant ECG abnormalities within 1 year
- Part II: History of vascular dementia
- Part II: Dementia or cognitive impairment from causes other than Alzheimer's disease
- Part II: Psychotic symptoms primarily from non-Alzheimer's conditions
- Part II: Use of contraindicated medications during entire study
- Part II: Use of unstable-dose cognitive-impairing medications within 8 weeks prior to screening
- Part II: Vaccinated within 5 days before investigational product administration
- Parts I & II: Clinically significant diseases affecting major organ systems, except mild conditions in elderly with medication discontinuation possible
- Parts I & II: Gastrointestinal diseases or surgeries affecting study safety or pharmacokinetics
- Parts I & II: Hypersensitivity to investigational product or related drugs
- Parts I & II: Positive serum tests for hepatitis B, C, HIV, or syphilis
- Parts I & II: History of alcohol or drug abuse or positive urine drug screen
- Parts I & II: Significant neurological exam abnormalities at screening
- Parts I & II: Abnormal vital signs outside defined blood pressure ranges
- Parts I & II: QT/QTc interval > 450 msec or significant ECG rhythm abnormalities
- Parts I & II: Abnormal lab test results including elevated liver enzymes or low kidney function
- Parts I & II: Use of prescription, herbal, OTC drugs, or supplements within specified windows prior to dosing
- Parts I & II: Use of enzyme-inducing or inhibiting drugs within 1 month prior to dosing
- Parts I & II: Participation in another clinical trial within 6 months
- Parts I & II: Recent blood donation or transfusion within specified timeframes
- Parts I & II: Current smokers or unable to abstain from smoking during study
- Parts I & II: Regular excessive alcohol or caffeine consumption or inability to abstain during study
- Parts I & II: Consumption of grapefruit or related foods during study
- Parts I & II: Unusual dietary habits or inability to follow standardized diet during hospitalization
- Parts I & II: Inability or unwillingness to use contraceptives or refrain from donating sperm/eggs during and after study
- Parts I & II: Dysphagia or inability to swallow multiple pills
- Parts I & II: Other reasons deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, Jongno-gu, South Korea, 03080
Actively Recruiting
Research Team
W
Woosik Kim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
12
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