The Alzheimer's Disease THErapy With NEuroaid (ATHENE) Study
NCT ID: NCT03038035
Last Updated: 2017-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
150 participants
INTERVENTIONAL
2016-12-31
2019-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
MLC901
24 weeks intervention with orally MLC901. 2 capsules 3 times a day
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.
Placebo
24 weeks intervention with orally placebo. 2 capsules 3 times a day
Interventions
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MLC901
24 weeks intervention with orally MLC901. 2 capsules 3 times a day
Placebo
24 weeks intervention with orally placebo. 2 capsules 3 times a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
120 Years
ALL
No
Sponsors
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National University Hospital, Singapore
OTHER
Responsible Party
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Locations
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National University Hospital
Singapore, Singapore, Singapore
Countries
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Central Contacts
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Facility Contacts
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Casuarine Low, Bsc (Hons)
Role: primary
References
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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.
Other Identifiers
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MLC901-2
Identifier Type: -
Identifier Source: org_study_id