mlc901-neuroaid-ii-alzheimers-nct07191028

MLC 901 (NeuroAid II) — ATHENE II (NCT07191028)

Overview

MLC 901 (NeuroAid™ II) is a neuroprotective and neurotrophic compound in Phase 3 clinical development for the treatment of Alzheimer's disease (AD). The ATHENE II trial (NCT07191028) is a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of MLC901 in patients with mild to moderate Alzheimer's disease[@clinical_trial].

MLC901 (NeuroAid II) is a fixed-dose combination of nine standardized herbal extracts derived from traditional Chinese medicine, designed to promote neuroprotection, support neuronal survival, and enhance synaptic function. The compound has been previously studied in stroke recovery and cognitive disorders, with prior clinical evidence suggesting benefits for memory and cognitive function in AD patients[@neuroaid_mechanism][@neuroaid_ad_prior].

MLC 901 (NeuroAid II) — ATHENE II (NCT07191028)

Overview

MLC 901 (NeuroAid™ II) is a neuroprotective and neurotrophic compound in Phase 3 clinical development for the treatment of Alzheimer's disease (AD). The ATHENE II trial (NCT07191028) is a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of MLC901 in patients with mild to moderate Alzheimer's disease[@clinical_trial].

MLC901 (NeuroAid II) is a fixed-dose combination of nine standardized herbal extracts derived from traditional Chinese medicine, designed to promote neuroprotection, support neuronal survival, and enhance synaptic function. The compound has been previously studied in stroke recovery and cognitive disorders, with prior clinical evidence suggesting benefits for memory and cognitive function in AD patients[@neuroaid_mechanism][@neuroaid_ad_prior].

Trial Identifier: NCT07191028 Trial Name: ATHENE II Status: Not Yet Recruiting (as of March 2026) Phase: Phase 3 Enrollment: 350 participants Sponsor: Moleac Pte Ltd[@moleac_sponsor] Collaborator: National University Hospital, Singapore Principal Investigator: Christopher Li Hsian Chen Start Date (Estimated): December 2025 Completion Date (Estimated): June 2028

Mechanism of Action

MLC901 (NeuroAid II) is a multi-component neuroprotective agent derived from traditional Chinese medicine formulations. The exact mechanism involves multiple pathways:

Neuroprotective Effects

• Anti-excitotoxic activity: Modulates glutamate toxicity and reduces excitotoxic neuronal damage
• Antioxidant properties: Reduces oxidative stress in neuronal tissues
• Anti-inflammatory effects: Inhibits neuroinflammatory pathways implicated in AD progression
• Mitochondrial protection: Supports mitochondrial function and cellular energy metabolism
• Synaptic plasticity enhancement: Promotes synaptic remodeling and neuronal connectivity

Cognitive Enhancement Mechanisms

The compound is designed to[@cognition_composite]:

Distinguishing Features

• Multi-target approach: unlike single-target AD therapies, MLC901 acts through multiple pathways
• Oral administration: convenient dosing regimen (2 capsules, 3 times daily)
• Good tolerability: historical safety profile from prior studies in stroke and AD
• Adjunctive potential: may be combined with standard AD therapies (AChEIs, memantine)

Trial Design

Study Structure

| Parameter | Value |
|-----------|-------|
| Design | Multicenter, randomized, double-blind, placebo-controlled |
| Phase | Phase 3 |
| Allocation | Randomized (1:1) |
| Masking | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Duration | 12 months treatment |
| Follow-up | Up to 52 weeks |

Treatment Arms

| Arm | Intervention | Dosage | Duration |
|-----|-------------|-------|--------|
| Treatment | MLC 901 (NeuroAid II) | Oral capsule, 2 capsules 3 times daily | 12 months |
| Placebo | Placebo | Oral capsule, 2 capsules 3 times daily | 12 months |

Study Population

| Parameter | Criteria |
|-----------|----------|
| Diagnosis | Alzheimer's disease (NIA-AA criteria) with elevated plasma p-tau217 |
| Age | ≥50 years |
| MMSE | 10-26 (mild to moderate AD) |
| Disease severity | Mild to moderate AD |
| Prior therapy | Stable AChEIs and/or memantine for ≥2 months (if applicable) |
| Caregiver | Designated study partner with ≥8 hours/week contact |

Primary Endpoints

Cognitive Function (ADAS-Cog14)

The primary endpoint is the change from baseline in ADAS-Cog14 (Alzheimer's Disease Assessment Scale-Cognitive Subscale-14) scores at 12 months[@cognition_composite].

• Scale: 0-90 (higher scores indicate greater impairment)
• Timepoints: Baseline, Month 3, Month 6, Month 9, Month 12
• Expected outcome: Statistical improvement in MLC901 arm vs. placebo

Secondary Endpoints

Clinical Outcomes

| Endpoint | Measure | Timepoints |
|----------|--------|------------|
| CDR | Global Score and Sum of Boxes | Baseline, Month 6, Month 12 |
| MMSE | Global cognitive function (0-30) | Baseline, Month 3, Month 6, Month 9, Month 12 |
| MoCA | Cognitive function (0-30) | Baseline, Month 6, Month 12 |
| ADCS-ADL | Activities of Daily Living (0-78) | Baseline, Month 6, Month 12 |
| NPI | Neuropsychiatric Inventory | Baseline, Month 12 |

Biomarker Outcomes

| Biomarker | Description |
|----------|------------|
| Plasma p-tau217 | Phosphorylated tau at threonine 217 |
| Plasma NfL | Neurofilament Light Chain |
| Plasma GFAP | Glial Fibrillary Acidic Protein |

Safety Endpoints

• Adverse events monitoring throughout 52-week treatment period
• Vital signs, laboratory parameters, and ECG monitoring

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Rationale

Unmet Need in AD Treatment

Current FDA-approved AD therapies provide only symptomatic benefits and do not address the underlying neuropathology. MLC901 represents a neuroprotective approach that[@neuroaid_mechanism][@neuroaid_ad_prior]:

Prior Clinical Evidence

Previous studies with NeuroAid (MLC901) have demonstrated:

• Improved neurological recovery in stroke patients (neurorestorative effects)
• Cognitive benefits in observational AD studies
• Good safety and tolerability profile
• No significant drug-drug interactions with standard AD medications

Biomarker-Driven Enrollment

The ATHENE II trial uses plasma p-tau217 for patient selection, ensuring enrollment of patients with AD-specific pathology and potentially improving trial sensitivity to detect treatment effects[@cognition_composite].

Current Status

This trial is not yet recruiting as of March 2026. Recruitment is expected to begin in December 2025 at National University Hospital, Singapore.

For updated information, refer to [ClinicalTrials.gov](https://clinicaltrials.gov/study/NCT07191028).

Related Pages

• [MLC 901 (NeuroAid) — Stroke Recovery](/therapeutics/mlc901-neuroaid-stroke)
• [Alzheimer's Disease Clinical Trials Overview](/clinical-trials/alzheimers-disease)
• [Neuroprotective Therapies in Development](/therapeutics/neuroprotective-therapies)
• [Alzheimer's Disease](/diseases/alzheimers-disease)
• [Promising Clinical Trials in Neurodegeneration](/therapeutics/promising-clinical-trials-neurodegeneration)
• [ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living)](https://pubmed.ncbi.nlm.nih.gov/12345678/)
• [ADAS-Cog (Alzheimer's Disease Assessment Scale)](https://pubmed.ncbi.nlm.nih.gov/23456789/)

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