NCT07191028

Alzheimer's Disease THErapy With NEuroaid II

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parellel-group Study to Assess the Efficacy and Safety of MLC901 (NeuroAiD™II) in Subjects With Mild to Moderate Alzheimer's Disease (AD).

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Moleac Pte Ltd. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Alzheimer's disease (AD) is a progressive neurodegenerative disorder with limited treatments that slow progression. Current symptomatic therapies provide modest benefit, while anti-amyloid agents target a single pathway and have uncertain long-term outcomes. Multitarget approaches may provide broader and more durable benefit. MLC901 (NeuroAiD™II), a Traditional Chinese Medicine derived formulation, has shown neuroprotective and neuroproliferative properties in preclinical studies through multimodal mechanisms, including modulation of amyloid beta and tau phosphorylation, reduction of oxidative stress and inflammation, and promotion of neurogenesis and synaptogenesis. Clinical studies, including the ATHENE trial, suggest MLC901 may slow cognitive decline and is well tolerated. ATHENE II is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study enrolling approximately 350 patients with mild to moderate AD across Southeast Asia. Participants will receive MLC901 or placebo for 12 months. The primary objective is to determine whether MLC901 is superior to placebo in slowing cognitive decline as measured by ADAS-Cog14. Secondary and exploratory objectives include global cognition, function, behavior, safety, and plasma biomarkers of AD (p-tau217, NfL and GFAP).

Conditions

• Alzheimer's Disease Dementia

Interventions

Type	Name	Description
DRUG	MLC 901	Oral capsule, 2 capsules 3 times a day for 12 months
DRUG	Placebo	Oral capsule, 2 capsules 3 times a day for 12 months

Timeline

• Start date: 2025-12-01
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2025-09-24
• Last updated: 2025-09-24

Locations

1 site across 1 country: Singapore