Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
BeyondBio Inc.
Age
55–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male and female adults at the age of ≥ 55 to ≤ 85 at the time of informed consent
Patients diagnosed according to the NIA-AA 2024 Criteria for Diagnosis with Mild Cognitive Impairment (MCI) or diagnosed with mild Alzheimer's disease
CDR-GS 0.5-1.0 at Screening
MMSE ≥ 20 at Screening
Amyloid-positive at amyloid PET scan
Patients who are capable of understanding information provided and can voluntarily sign written informed consent form
Patients who completed the 26-week visit in the Main Study
Patients who provided written consent to participate in the Extension Study
You may not be if
Subjects diagnosed with cognitive impairment due to causes other than substrate causes such as brain lesions, psychiatric disorders, or Alzheimer's disease (e.g., stroke, Parkinson's disease, Lewy body disease, vascular dementia)
Subjects with any of the following cardiovascular diseases at Screening
\* Cerebrovascular disease within the past 6 months (cerebral infarction, cerebral hemorrhage, transient ischemic attack, etc.)
* Myocardial infarction or unstable angina pectoris within the past 6 months
* New York Heart Association (NYHA) Class II congestive heart failure
* QTcF ≥450 msec or clinically significant electrocardiogram (ECG) abnormalities
Patients with malignant tumors
Patients with medical conditions that can affect cognitive decline such as hypothyroidism, vitamin B12 or folate deficiency, niacin deficiency, etc.
Patients with a history of alcohol related disorders within the past 6 months
Patients with a positive HIV antibody test result at Screening
Patients with a positive HBs antigen or HCV antibody test at Screening
Patients with active bacterial infections who have received antibiotics within 7 days prior to Screening.
Patients with a history of hypersensitivities to any of the components of investigational product
Patients who have been hospitalized or treated for suicidal behavior within 5 years prior to Screening or whose C-SSRS results at Screening indicate serious suicidal ideation or behavior
Patients who have received treatment for Alzheimer's disease (e.g., Lecanemab) within 6 months prior to Screening
Patients expected to require the administration of a long-acting benzodiazepine (BDZ) for the treatment of sleep disorders at Screening
Any of the following laboratory test values at Screening:
* Serum Creatinine \>1.5×ULN or eGFR (MDRD) \<40 mL/min/1.73 m2
* Any of the following: AST, ALT \>3×ULN, or Total bilirubin \>2xULN
Women who test positive for pregnancy at Screening, or women and men of childbearing potential who are planning to become pregnant, or who do not agree to use adequate contraception\* during the study and for 4 weeks after the end of study drug administration
\*Adequate contraception: complete abstinence, hormonal contraceptives with no known drug interactions \[Levonorgestrel intrauterine system (IUS) (Mirena), Medroxyprogesterone\], surgical sterilization (including vasectomy, bilateral salpingectomy and ligation). However, intermittent abstinence (e.g., using ovulation timing, symptothermal method, or post-ovulation) or external ejaculation are not considered adequate contraception.
Pregnant or lactating women or women who are tested positive for pregnancy at Screening
Patients treated with other IP within 4 weeks prior to screening
Patients who are considered ineligible for study participation for other reasons based on the judgment of the investigator
\[Extension Study\]
Subjects who have dropped out of the Main Study
Patients who, in the investigator's judgement, are not suitable for participation in Extension Study
Any of the following laboratory test values at Baseline:
* Serum Creatinine \>1.5×ULN or eGFR (MDRD) \<40 mL/min/1.73 m2
* Any of the following: AST, ALT \>3×ULN, or Total bilirubin \>2xULN
