Study protocol for a phase III randomised controlled trial of Sailuotong (SLT) for vascular dementia and Alzheimer's disease with cerebrovascular disease.

Autor: Karamacoska D; NICM Health Research Institute, Western Sydney University, Penrith, NSW, Australia., Chan DKY; NICM Health Research Institute, Western Sydney University, Penrith, NSW, Australia.; South Western Sydney Clinical School, University of New South Wales, Kensington, NSW, Australia., Leung I; NICM Health Research Institute, Western Sydney University, Penrith, NSW, Australia., Liu JX; Research Center, Xiyuan Hospital, China Academy of Traditional Chinese Medicine, Beijing, China., Brodaty H; Centre for Healthy Brain Ageing, School of Psychiatry, University of New South Wales, Kensington, NSW, Australia., Fahey PP; School of Health Sciences, Western Sydney University, Penrith, NSW, Australia., Bensoussan A; NICM Health Research Institute, Western Sydney University, Penrith, NSW, Australia., Chang DH; NICM Health Research Institute, Western Sydney University, Penrith, NSW, Australia.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2023 Mar 15; Vol. 18 (3), pp. e0265285. Date of Electronic Publication: 2023 Mar 15 (Print Publication: 2023).
DOI: 10.1371/journal.pone.0265285
Abstrakt: Vascular dementia (VaD) accounts for 15-20% of all dementia cases. It is a syndrome of acquired cognitive impairment with a complex pathophysiological basis. A novel herbal formulation (Sailuotong; SLT) consisting of Panax ginseng C.A Mey, Ginkgo biloba L and Crocus sativus L extracts was developed to treat VaD. Preclinical animal studies found significant improvements in memory and in pathogenic biochemical parameters. Appropriate safety of SLT was shown in acute and chronic toxicity studies, and early clinical trials of SLT demonstrated enhancements in cognition in VaD patients. A fully powered study with a long intervention period is needed to confirm the efficacy and safety of this novel intervention. A rigorous phase III clinical trial was developed with the aim of recruiting 238 patients diagnosed with mild to moderate probable VaD, or VaD mixed with Alzheimer's disease (where cerebrovascular disease is the clinical dominant contributor to dementia, abbreviated as CVD+AD). Using a permuted block strategy, participants will be randomly allocated to receive SLT (120 mg bd) or placebo capsules for an intervention period of 52 weeks and will be followed-up for an additional 13 weeks. The primary outcome measures are the Vascular Dementia Assessment Scale-cognitive subscale and Alzheimer's Disease Cooperative Study-Activities of Daily Living scale. Secondary outcome measures include the Clinician's Interview Based Impression of Change-Plus, CLOX, EXIT-25, Neuropsychiatric Inventory-Clinician rating scale, and Dementia Quality of Life questionnaire. Safety is assessed through adverse event reports and liver, renal, and coagulation studies. Primary and secondary outcome measures will be compared between treatment and placebo groups, using intention to treat and per protocol analyses. We hypothesise that a 52-week treatment of SLT will be clinically effective and well tolerated in participants with VaD or AD+CVD. This project will provide vital efficacy and safety data for this novel treatment approach to VaD.
Competing Interests: As a medical research institute, NICM receives research grants and donations from foundations, universities, government agencies, individuals, and industry. Sponsors and donors provide untied funding for work to advance the vision and mission of the institute. The project that is the subject of this article was not undertaken as part of a contractual relationship with any organisation other than the funding that was previously declared in the Funding section. The authors declare that they have no competing interests.
(Copyright: © 2023 Karamacoska et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
Databáze: MEDLINE
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