BnH-015B Clinical Trial in Moderate Alzheimer's Disease
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * \[Part I\] 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 * \[Part II\] Indi