Please use this identifier to cite or link to this item: https://doi.org/10.1016/j.trci.2018.12.001
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dc.titleThe Alzheimer's disease THErapy with NEuroaid (ATHENE) study protocol: 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
dc.contributor.authorChen, C.L.H.
dc.contributor.authorSharma, P.R.
dc.contributor.authorTan, B.Y.
dc.contributor.authorLow, C.
dc.contributor.authorVenketasubramanian, N.
dc.date.accessioned2021-12-29T04:38:42Z
dc.date.available2021-12-29T04:38:42Z
dc.date.issued2019
dc.identifier.citationChen, C.L.H., Sharma, P.R., Tan, B.Y., Low, C., Venketasubramanian, N. (2019). The Alzheimer's disease THErapy with NEuroaid (ATHENE) study protocol: 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. Alzheimer's and Dementia: Translational Research and Clinical Interventions 5 : 38-45. ScholarBank@NUS Repository. https://doi.org/10.1016/j.trci.2018.12.001
dc.identifier.issn23528737
dc.identifier.urihttps://scholarbank.nus.edu.sg/handle/10635/212354
dc.description.abstractBackground: Dementia is a large and growing health care burden globally, and its major cause is Alzheimer's disease (AD). MLC901 (Neuroaid II) is a simplified form of MLC601 (Neuroaid), a Traditional Chinese Medicine with neuroprotective and neuroproliferative properties in cellular and animal models of brain injury. MLC601 has been shown to modulate amyloid precursor protein (APP) processing in human neuroblastoma cell cultures and increase the levels of soluble APP?. In addition, MLC901 has been shown to reduce tau phosphorylation in vitro. Hence, MLC901 may have possible multimodal actions and a disease-modifying effect in AD. In previous clinical studies, MLC601 has shown promising effects in AD. Objective: To investigate the safety and efficacy of MLC901 add-on therapy to standard treatment in mild-to-moderate probable AD patients stable on standard treatment and to evaluate if MLC901 has a disease-modifying effect in AD. Methods: This is a 6-month randomized, double-blind, placebo-controlled trial in mild-to-moderate probable AD where MLC901 will be given as an add-on therapy to standard AD treatment, followed by an extension study for another 6 months, where all subjects will be treated with open-label MLC901 in addition to standard treatment. The primary outcome is safety as measured by adverse events, vital signs, electrocardiogram, laboratory tests, and physical and neurological examinations. Secondary outcomes evaluating cognition, behavior, and activities of daily living at various time points include the Alzheimer's Disease Assessment Scale–cognitive subscale, Alzheimer's Disease Cooperative Study–Clinical Global Impression of Change, Alzheimer's Disease Cooperative Study–Activities of Daily Living Inventory, Neuropsychiatric Inventory, and Mini–Mental State Examination. Conclusion: MLC901 has the potential to improve cognition in AD patients. It may also have a role in delaying disease progression. This study will be the first to provide safety and efficacy data for MLC901 in mild-to-moderate probable AD patients already receiving standard therapy. © 2018 [Author/Employing Institution]
dc.publisherElsevier Inc
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0/
dc.sourceScopus OA2019
dc.subjectAlzheimer's disease
dc.subjectClinical trial
dc.subjectDisease progression
dc.subjectMLC901
dc.subjectNeuroaid II
dc.typeArticle
dc.contributor.departmentDEPT OF PHARMACOLOGY
dc.description.doi10.1016/j.trci.2018.12.001
dc.description.sourcetitleAlzheimer's and Dementia: Translational Research and Clinical Interventions
dc.description.volume5
dc.description.page38-45
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