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

January 26, 2017 updated by: National University Hospital, Singapore

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 118 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, age ≥50 years
  • Diagnosed with probable AD according to NINCDS-ADRDA criteria,
  • MMSE score of 10 to 24,
  • Receiving the same AChEI or Memantine for the past 6 months prior to screening and on a stable dose for the past 4 months (stable dose is defined as 5 to 10mg/day for Donepezil, 3, 4.5 or 6 mg twice daily for rivastigmine capsules, 4.6 or 9.5 mg for rivastigmine transdermal patch once daily, 8 or 12 mg twice daily for galantamine tablets, 16 to 24 mg once daily for galantamine capsules XL, 10 mg OD or 10 mg BD for Memantine)
  • Patient or legal representative is able to provide informed consent

Exclusion Criteria:

  • Patients receiving any investigational product within 60 days or 5 half-lives prior to screening
  • Any serious medical or psychiatric condition which in the investigator's judgement may jeopardize the patient by his/her participation in this study or may hamper his/her ability to perform and complete procedures required in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MLC901

NeuroAid II MLC901 is a derivative product of NeuroAid MLC601. It is a simplified formula based on the 9 Herbal ingredients that are present in NeuroAid MLC 601. Neuroaid II has been approved for sale as a Chinese Proprietary Medicine in Singapore by the HSA since March 2010. 24 weeks intervention. Dosage: 2 capsules 3 times a a day

Upon completion of 24 weeks, subject will be given an option to continue an open-label extension for another 24 weeks.
Drug: MLC901
24 weeks intervention with orally MLC901. 2 capsules 3 times a day
Other Names:
  • Neuroaid II (MLC901)
Placebo Comparator: Placebo

24 weeks intervention with orally placebo. 2 capsules 3 times a day.

Upon completion of 24 weeks, subject will be given an option to continue an open-label extension for another 24 weeks.
Drug: Placebo
24 weeks intervention with orally placebo. 2 capsules 3 times a day
Other Names:
  • MLC901 matched Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluating the safety of MLC901 when it is given in combination with the standard treatment.The safety will be evaluated by adverse events, vital signs, ECG and laboratory tests, physical and neurological examinations at 6 months.
Time Frame: week 24
week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effect of MLC901 as add on therapy to standard treatments for 6 months on cognitive function in patients with mild to moderate AD using Alzheimer's Disease Assessment Scale- cognitive subscale (ADAS- Cog).
Time Frame: week 24
week 24
Evaluate the effect of MLC901 as add on therapy to standard treatments for 6 months on cognitive function in patients with mild to moderate AD using Mini Mental State Examination (MMSE).
Time Frame: week 24
week 24
Evaluate the long term safety of MLC901 as add-on treatment to standard treatments for up to 1 year in an open extension study with adverse events, vital signs, ECG and laboratory tests, physical and neurological examination at 1 year.
Time Frame: week 48
week 48
Evaluate the long term effect on disease progression of MLC901 as add-on treatment to standard treatments for up to 1 year in an open extension study by assessing Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (ADCS- CGIC).
Time Frame: week 48
Using all of the other results (ADCS- ADL23, NPI, ADAS-Cog and MMSE) together would provide an accurate assessment of the disease progression.
week 48
Evaluate the long term effect on disease progression of MLC901 as add-on treatment to standard treatments for up to 1 year in an open extension study by assessing Alzheimer's Disease Cooperative Study- Activities of Daily Living Inventory (ADCS- ADL23)
Time Frame: week 48
Using all of the other results (ADCS-CGIC, NPI, ADAS-Cog and MMSE) together would provide an accurate assessment of the disease progression.
week 48
Evaluate the long term effect on disease progression of MLC901 as add-on treatment to standard treatments for up to 1 year in an open extension study by assessing Neuropsychiatric Inventory (NPI).
Time Frame: week 48
Using all of the other results (ADCS-CGIC, ADCS-ADL23, ADAS-Cog and MMSE) together would provide an accurate assessment of the disease progression.
week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

November 1, 2016

First Submitted That Met QC Criteria

January 26, 2017

First Posted (Estimate)

January 31, 2017

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 26, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MLC901-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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