NCT03038035

The Alzheimer's Disease THErapy With NEuroaid (ATHENE) Study

The Alzheimer's Disease THErapy With NEuroaid (ATHENE) Study : Assessing the Safety and Efficacy of Neuroaid II (MLC901) in Patients With Mild to Moderate Alzheimer's Disease Stable on Cholinesterase Inhibitors or Memantine: A Randomized, Double Blind, Placebo Controlled Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 50 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

MLC601 (Neuroaid) is a Traditional Chinese Medicine (TCM) having neuroprotective and neuroproliferative properties in cellular and animal models of brain injury. It contains 9 herbal and 5 non-herbal components. MLC901 (Neuroaid II), a simplified formula of MLC601, containing only the 9 herbal components yet showing the same efficacy has become available. This study is carried out to find out if NEUROAID II (MLC901) is safe to be taken together with other established medicines for Alzheimer's disease and whether NEUROAID II (MLC901) helps in slowing down the Alzheimer's disease progression. This study will be a 6-month randomized, double-blind, placebo-controlled trial, followed by an open extension study in which all subjects who completed the main 6 month trial (irrespective of treatment allocation) will be offered open-labelled MLC901 for another 6 months.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	MLC901	24 weeks intervention with orally MLC901. 2 capsules 3 times a day
DRUG	Placebo	24 weeks intervention with orally placebo. 2 capsules 3 times a day

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-06-01
• Completion: 2019-06-01
• First posted: 2017-01-31
• Last updated: 2017-01-31

Locations

1 site across 1 country: Singapore