Alzheimer's Disease THErapy With NEuroaid II (NCT07191028) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Alzheimer's Disease THErapy With NEuroaid II
Singapore350 participantsStarted 2025-12
Plain-language summary
ATHENE II is a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial designed to evaluate the efficacy and safety of MLC901 in subjects with mild to moderate Alzheimer's disease, as well as its effects on plasma biomarkers compared to placebo.
Who can participate
Age range50 Years
SexALL
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Inclusion Criteria:
* Male or female subjects aged ≥ 50 years at the time of providing informed consent.
* Diagnosis of AD based on the National Institute on Ageing and the Alzheimer's Association criteria, supported by the presence of a Core 1 AD biomarker, specifically elevated plasma ptau217.
* MMSE score between 10 and 26, inclusive, at baseline, corresponding to mild to moderate AD.
* Subjects may be either treatment-naïve or currently receiving stable symptomatic treatment for AD for at least the 2 months prior to screening, including AChEIs, memantine, or a combination of both.
* Subjects must have a designated study partner who provides ongoing support during the study and interacts with the subject for a minimum of 8 hours per week, and will accompany the subject to study visits or be available by telephone at designated times. A second study partner may serve as backup. If the original study partner withdraws from participation, a replacement study partner may be permitted at the investigator's discretion. The replacement study partner must provide informed consent prior to their first study visit with the subject.
* Both the subject (or their legally authorized representative) and the study partner(s) must be capable of providing informed consent.
* Subjects must have adequate literacy, vision, and hearing, in the opinion of the investigator at the time of screening, to allow for valid administration of the clinical outcome assessments.
Exclusion Criteria:
* Pre…