Abstract
BackgroundMild cognitive impairment (MCI) is a syndrome characterised by a decline in cognition but relatively intact activities of daily living. People with MCI have an increased risk of developing dementia, and MCI is often referred to as a transitional stage between healthy ageing and dementia. Currently, there are no pharmaceutical therapies approved by the US Federal Drug Administration for MCI. Randomised controlled trials on the two major classes of anti-dementia pharmaceuticals, cholinesterase inhibitors and glutamate receptor antagonists, have produced poor results in MCI cohorts. There is a need to test and evaluate new and promising treatments for MCI that target multiple aspects of the syndrome’s multi-faceted pathophysiology. The primary aim of this study is to evaluate the efficacy of 12 weeks of treatment with a standardised herbal formula, Sailuotong (SLT), compared to placebo, on cognition in older adults with MCI. Secondary aims are to assess SLT’s mechanisms of action via electroencephalography (EEG), autonomic function, brain blood flow, and inflammation, as well as its safety in this cohort.Methods/designThe target cohort for this trial is community-dwelling older adults over the age of 60 years who meet the National Institute of Aging-Alzheimer’s Association working group core clinical criteria for MCI due to Alzheimer’s disease. Eighty participants will be recruited and randomly allocated via a permuted block strategy at a 1:1 ratio to either the treatment or placebo group. The co-primary cognitive outcome measures are Logical Memory Story A delayed recall (episodic memory), Letter Number Sequencing (perceptual processing speed), and both the Trail Making Test and Rey Complex Figure Test (executive function). Secondary outcome measures are EEG activity, autonomic function (via electrocardiogram, skin conductance, and peripheral pulse pressure), brain blood flow (via common carotid artery ultrasound), and serum concentrations of inflammatory cytokines. Analyses will be performed blind to group allocation.DiscussionThis study is a 12-week, randomised, double-blind, placebo-controlled trial. Primary and secondary outcome measures will be compared between treatment and placebo groups at baseline and endpoint. Data from this pilot study will inform a larger, more highly powered clinical trial if the findings are positive.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12617000371392 Registered on 10 March 2017.
Highlights
Mild cognitive impairment (MCI) is a syndrome characterised by a decline in cognition but relatively intact activities of daily living
Primary and secondary outcome measures will be compared between treatment and placebo groups at baseline and endpoint
There are no approved treatment options for MCI, and evidence on anti-dementia pharmaceuticals does not support their use in people with MCI [3,4,5]
Summary
SLT has shown efficacy in improving cognition in people with vascular dementia and in enhancing neuronal activity and cerebral perfusion in healthy adults and in seniors with vascular dementia, respectively. Current efforts to address the cognitive deficits in MCI using single-target pharmaceuticals, such as cholinesterase inhibitors, have yielded poor and inconsistent results, highlighting the need for new and innovative strategies This randomised controlled trial focuses on SLT, a potential treatment that has been shown to address MCI’s multi-faceted pathophysiology in preclinical studies and has yielded positive results from pilot clinical trials in healthy adults and people with vascular dementia. The outcomes of this trial will inform the development of future interventional research involving people with MCI, such as a large-scale conversion study.
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