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

NCT03038035 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2017-01-31

No results posted yet for this study

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

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

Sponsors & Collaborators

  • National University Hospital, Singapore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2018-06-30
Completion
2019-06-30

Countries

  • Singapore

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03038035 on ClinicalTrials.gov