Recruiting PHASE1 Alzheimer Disease

New treatment option for Alzheimer Disease

Official title BnH-015B Clinical Trial in Moderate Alzheimer's Disease

ClinicalTrials.gov ID: NCT06535308

What this study is testing

What is BnH-015B 5 mg?

BnH-015B 5 mg is an investigational medicine, being studied as a potential treatment for alzheimer disease.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing: 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.

Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 19 to 45. Healthy volunteers may be eligible.

You may be able to join if

[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)...
[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...
[Part II] Patients diagnosed within the last 5 years prior to screening

You likely can't join if

[Part II] Patients with a history of unstable angina, myocardial infarction, progressive chronic heart failure (New York Heart Association class III...
[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...
[Part II] Patients with psychotic symptoms primarily due to conditions other than Alzheimer's disease causing dementia (e.g., schizophrenia...
[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...

See the full eligibility criteria

Who can join

[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...
[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...
[Part II] Individuals who possess sufficient vision, hearing, language ability, motor function, and comprehension to follow the test procedures in the investigator's judgment
[Part I\&II] Individuals who weigh between 55.0 kg and 90.0 kg and have a body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2 at the time of the screening
[Part I\&II] Individuals who have received a full explanation about this clinical trial, completely understand it, and voluntarily decide to participate and agree in writing to follow the instructions (however, for Part...
[Part I\&II] Individuals deemed suitable as people for this study by the investigator based on physical examinations, clinical laboratory tests, and medical history evaluations

What rules you out

[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...
[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...
[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...
[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...
[Part II] Patients who have been vaccinated (including COVID-19 vaccines and booster shots) within 5 days prior to the administration of the investigational product
[Part I\&II] Individuals with clinically significant diseases or medical history in systems such as hepatobiliary, renal, neurological, immune, respiratory, gastrointestinal, endocrine, hematologic/oncologic...
[Part I\&II] Individuals with gastrointestinal diseases (such as Crohn's disease, ulcers, gastritis, gastric spasms, and gastroesophageal reflux disease) or a history of surgery (except for simple appendectomies or...
[Part I\&II] Individuals who have hypersensitivity reactions or have a clinically significant history of hypersensitivity reactions to drugs that contain the ingredient of the investigational product (BnH-015B) and...
[Part I\&II] Individuals with positive results in serum tests (hepatitis B, hepatitis C, human immunodeficiency virus (HIV), syphilis)
[Part I\&II] Individuals with a history of alcohol or drug abuse, or positive results for abused drugs in a urine drug screening test
[Part I\&II] Individuals who exhibit significant abnormalities in neurological examinations conducted at the time of screening
[Part I\&II] Individuals who show the following vital sign values when measured in a seated position after at least 3 minutes of rest: Systolic blood pressure \ 139 mmHg, Diastolic blood pressure \ 89 mmHg
[Part I\&II] Individuals who exhibit a QT/QTc interval \> 450 msec or clinically significant abnormal rhythm findings on an electrocardiogram during screening
[Part I\&II] Individuals who show one or more of the following results in clinical laboratory tests during screening including additional tests: Blood levels of AST (SGOT), ALT (SGPT) \> 1.5 times the upper limit of the...
[Part I\&II] Individuals who have taken any prescription drugs or herbal medicine within 2 weeks prior to the planned administration date of the investigational product, or any over-the-counter (OTC) drugs, dietary...
[Part I\&II] Individuals who have taken enzyme-inducing drugs like barbiturates or enzyme-inhibiting drugs like clarithromycin within 1 month prior to the planned administration date of the investigational product
[Part I\&II] Individuals who have participated in another clinical trial (including bioequivalence studies) and received an investigational product within 6 months prior to the planned administration date of the...
[Part I\&II] Individuals who have donated whole blood within 2 months or components of blood within 1 month or received a blood transfusion within 2 months prior to the planned administration date of the investigational...
[Part I\&II] Current smokers (however, those who quit smoking at least 3 months prior to the planned administration date of the investigational product can be enrolled as people) or individuals who cannot abstain from...
[Part I\&II] Individuals who regularly consume alcohol (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or cannot abstain from alcohol from 3 days prior to the first expected administration date until the end of...
[Part I\&II] Individuals who have regularly consumed excessive caffeine (exceeding 5 units/day) or cannot abstain from consuming caffeine-containing foods and beverages (such as coffee, tea (black, green, etc.)...
[Part I\&II] Individuals who have consumed grapefruit, grapefruit juice, or grapefruit-containing foods from 3 days prior to the planned administration date of the investigational product until the end of the study, or...
[Part I\&II] Individuals with unusual dietary habits (e.g., drinking more than 1 liter of grapefruit juice per day) or who cannot consume the standardized diet provided by the clinical trial center during the...
[Part I\&II] Individuals who, or whose spouses (or partners), are unable or unwilling to use medically acceptable contraceptive methods during the entire study period and for at least 3 months after the last...
[Part I\&II] Individuals with dysphagia or who are unable to swallow multiple pills
[Part I\&II] Individuals deemed unsuitable for participation by the investigator for any other reason not specified above

The study team makes the final eligibility decision.

Where it's taking place

Seoul, Jongno-gu, South Korea

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 19 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Seoul, Jongno-gu, South Korea. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.