NCT06535308
BnH-015B Clinical Trial in Moderate Alzheimer's Disease
Recruiting · Phase 1 · BnH Research · registry updated 2025-01-07
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- \[Part I\] Young adults: Healthy Korean or Caucasian male volunteers aged between 19 and 45 at the time of screening
- \[Part II\] Individuals aged between 55 and 85 years at the time of informed consent
- \[Part II\] The subject must be diagnosed with probable AD dementia according to the National Institute of Aging and Alzheimer Association (NIA-AA) diagnostic guidelines and must meet all of the following clinical criteria: MMSE score: 10-19, CDR-Global Score: 2
- \[Part II\] Patients who are positive for P-tau181 and osteopontin in serum at the time of screening and are confirmed as amyloid positive via amyloid PET
- \[Part II\] Patients diagnosed within the last 5 years prior to screening
- \[Part II\] The subject (or the subject's legal representative) and caregiver must sign the consent for participation in the study, and the same caregiver must assist the subject throughout the entire study period and be continuously available for contact
Exclusion
- \[Part II\] Patients with a history of unstable angina, myocardial infarction, progressive chronic heart failure (New York Heart Association class III or IV), or clinically significant electrocardiographic abnormalities within the year prior to screening
- \[Part II\] Patients with a history of vascular dementia
- \[Part II\] Patients diagnosed with dementia or cognitive impairment not related to Alzheimer's disease, including but not limited to significant head trauma, alcohol abuse, frontotemporal dementia, Huntington's disease, Parkinsonian syndromes (e.g., Parkinson's disease, Lewy body dementia), significant cerebrovascular disease, and/or significant seizure disorders
- \[Part II\] Patients with psychotic symptoms primarily due to conditions other than Alzheimer's disease causing dementia (e.g., schizophrenia, schizoaffective disorder, delusional disorder, or mood disorders with psychotic symptoms)
- \[Part II\] Patients who must take contraindicated medications throughout the entire study period
- \[Part II\] Patients who have used cognitive-impairing, long-term permissible concomitant medications (e.g., antidepressants, anticonvulsants, atypical and typical antipsychotics, benzodiazepines) in unstable doses for at least 8 weeks prior to screening visit and during the screening period