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

NCT03038035 | Unknown Phase 2 DMC

• 1 other identifier: MLC901-2
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  week 24

Secondary Outcomes (6)

• 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).

  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).

  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.

  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).

  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)

  week 48

Study Arms (2)

MLC901

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

MLC901 DRUG

24 weeks intervention with orally MLC901. 2 capsules 3 times a day

Also known as: Neuroaid II (MLC901)

MLC901

Placebo DRUG

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

Also known as: MLC901 matched Placebo

Placebo

Eligibility Criteria

• Age: 50 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore, 119074, Singapore

RECRUITING

Related Publications (1)

• Chen CLH, Lu Q, Moorakonda RB, Kandiah N, Tan BY, Villaraza SG, Cano J, Venketasubramanian N. Alzheimer's Disease THErapy With NEuroaid (ATHENE): A Randomized Double-Blind Delayed-Start Trial. J Am Med Dir Assoc. 2022 Mar;23(3):379-386.e3. doi: 10.1016/j.jamda.2021.10.018. Epub 2021 Nov 29.

  PMID: 34856171 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Neuroaid

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Casuarine Low, BSc

CONTACT

66015666; casuarine_low@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: January 31, 2017
• Study Start: December 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2019
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

SG (1)