Ignite Creation Date:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2025-12-31 @ 8:15 PM
Study NCT ID:
NCT07191028
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alzheimer's Disease THErapy With NEuroaid II
Sponsor:
Moleac Pte Ltd.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATHENE II
Brief 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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: