∙ Participants must meet all the following criteria to be eligible for this study:

• Age between 60 and 85 years (inclusive, based on the date of signing the informed consent), applicable to all genders.

• Must meet the 2024 Alzheimer's Association (AA) Workgroup revised criteria for diagnosing MCI due to AD or mild AD dementia.

• CDR score: At screening and baseline, the CDR global score must be 0.5 or 1.0, and the CDR memory score must be 0.5 or higher.

• MMSE score: At screening, the MMSE score must be 22 or higher.

• Body mass index (BMI): At screening, BMI must be greater than 17 and less than 35 (inclusive).

• History of memory decline: A history of at least 6 months of gradual and progressive memory decline prior to signing ICF must be reported and confirmed by an informant.

• Blood p-tau 217: positive (For participants with evidence suggesting Aβ-PET positivity, absence blood p-tau 217 determination is not considered a protocol deviation.).

• Aβ- PET scan: Visual read of Aβ-PET scan must be positive.

• Study partner: Must have a designated study partner who can support the participants and spend at least 8 h per week with them during the study. The partner must provide a separate written informed consent and be willing and able to provide follow-up information about the participant. They should regularly spend enough time with the participants to reliably meet study requirements. The study partner does not need to live with the participant but should be easily reachable during the study. If the partner is unable to continue supporting due to health or other reasons, it is allowed to replace with another eligible partner. The replacement partner must provide a separate written informed consent and be willing and able to provide follow-up information about the participant.

⁃ Concomitant medication: Participants who are receiving cholinesterase inhibitors and/or memantine for AD can be enrolled into the study, but must be on a stable dose for at least 12 weeks prior to baseline. For all other (i.e., non-AD-related) allowed concomitant medications, participants must receive a stable dose (not for topical, as needed \[PRN\], or discontinued medications) for at least 4 weeks prior to baseline unless otherwise stated.

⁃ Contraception:

⁃ a.Male participants i.Male participants, regardless of childbearing potential, if their non-pregnant female partner is a female of childbearing potential, must agree to maintain abstinence (if this is their preferred and usual lifestyle) or to use a barrier method and another highly effective (failure rate less than 1%) method of contraception (see Section 17.5 for details) until 90 days after the last dose of IP.

⁃ ii.Male participants with pregnant partners should use condoms during intercourse for the duration of the study and until the end of the estimated relevant potential exposure for women of childbearing potential (WOCBP; expected to be 90 days after the last dose of IP).

⁃ iii.Male participants should refrain from sperm donation for the duration of the study and until 90 days following the last dose of IP.

⁃ b.Female participants i.WOCBP must use, or be willing to use, two forms of effective contraception (a barrier method and one other highly effective method of contraception, as detailed in Section 17.5) during participation in the trial and for 90 days after the last dose of the IP.

⁃ ii.WOCBP potential is defined as those who are:

⁃ ① Following menarche

⁃ ② From the time of menarche until becoming postmenopausal unless permanently sterile (see below) A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.

‣ In the absence of 12 months of amenorrhea, confirmation with more than one follicle-stimulating hormone (FSH) measurement is required.

‣ Individuals receiving hormone replacement therapy (HRT) whose menopausal status is in doubt will be required to use a non-estrogenic, highly effective contraceptive method if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment.

⁃ Permanent sterilization methods and gender-affirming procedures (for the purpose of this study) include:

‣ Documented hysterectomy

‣ Documented bilateral salpingectomy

‣ Documented bilateral oophorectomy

‣ For individuals with permanent infertility due to an alternate medical cause other than the above, (e.g., Mullerian agenesis, androgen insensitivity, gonadal dysgenesis), investigator discretion should be applied to determining study entry.

⁃ iii.All WOCBP must be negative at Visit 1 based on a serum pregnancy test.

⁃ Informed consent: Must obtain a voluntary signed ICF, approved by an Ethics Committee, from the participants or their legal representative before any study procedure.

⁃ Language proficiency: Must be fluent in the language used at the study site.

⁃ Protocol compliance: Must be willing and able to comply with all aspects of the protocol.