Alzheimer's Disease THErapy With NEuroaid (ATHENE): A Randomized Double-Blind Delayed-Start Trial.

Autor:	Chen CLH; Memory Ageing and Cognition Centre, National University Health System, Singapore; Departments of Pharmacology and Psychological Medicine, National University of Singapore, Singapore. Electronic address: phccclh@nus.edu.sg., Lu Q; Singapore Clinical Research Institute, Singapore; Duke-National University of Singapore Medical School, Singapore., Moorakonda RB; Singapore Clinical Research Institute, Singapore., Kandiah N; Duke-National University of Singapore Medical School, Singapore; Department of Neurology, National Neuroscience Institute (TTSH Campus), Singapore; Lee Kong Chian School of Medicine, Singapore., Tan BY; St. Luke's Hospital, Singapore., Villaraza SG; Memory Ageing and Cognition Centre, National University Health System, Singapore., Cano J; Memory Ageing and Cognition Centre, National University Health System, Singapore., Venketasubramanian N; Raffles Neuroscience Centre, Raffles Hospital, Singapore.
Jazyk:	angličtina
Zdroj:	Journal of the American Medical Directors Association [J Am Med Dir Assoc] 2022 Mar; Vol. 23 (3), pp. 379-386.e3. Date of Electronic Publication: 2021 Nov 29.
DOI:	10.1016/j.jamda.2021.10.018
Abstrakt:	Objectives: Preclinical and clinical studies indicate a role for MLC901 (NeuroAiD II) in Alzheimer's disease (AD). The primary aim was to investigate its safety as add-on therapy to standard treatment and the secondary aims its effect on cognition and slowing disease progression. Design: Randomized double-blind placebo-controlled delayed-start study. Setting and Participant: Patients with mild to moderate probable AD by NINCDS-ADRDA criteria, stable on acetylcholinesterase inhibitors or memantine (n = 125), were randomized to receive MLC901 (early starters) or placebo (delayed starters) for 6 months, followed by a further 6 months when all patients received MLC901, in a delayed-start design (clinical trial registration: ClinicalTrials.gov, NCT03038035). Methods: The primary outcome measure was occurrence of serious adverse events (SAEs) at 6 months. Secondary outcomes included the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) and other assessment scales. Results: There was no significant difference in the risk of SAEs between early and delayed starters at month (M) 6 (22.6% vs 27.0%, risk difference -4.4%, 90% CI -16.9% to 8.3%). Similarly, there was no significant difference in the risk of adverse events and the occurrence of stroke or vascular events between early and delayed starters throughout the 12-month study period. Early starters did not differ significantly on ADAS-Cog from delayed starters at M6 [mean difference (MD) -1.0, 95% CI -3.3 to 1.3] and M12 (MD -2.35, 95% CI -5.45 to 0.74) on intention-to-treat analysis. Other cognitive assessment scales did not show significant differences. Conclusions and Implications: This study of 125 persons with dementia found no evidence of a significant increase in adverse events between MLC901 and placebo, thus providing support for further studies on both efficacy and safety. Analyses suggest the potential of MLC901 in slowing down AD progression, but this requires further confirmation in larger and longer studies using biomarkers for AD. (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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