World-first clinical trial offers new hope in the treatment of mild cognitive impairment among older people

Western Sydney University's NICM Health Research Institute has led a world-first clinical trial in Australia that offers new hope in the treatment of mild cognitive impairment (MCI) among older people. The trial's results, published in Alzheimer's and Dementia: Diagnosis, Assessment and Disease Monitoring, a journal of the Alzheimer's Association, signal the efficacy and safety of Sailuotong (SLT), a novel herbal extract, as a potential treatment for MCI.

Trial participants taking SLT showed improvements in aspects of memory and executive function including delayed episodic memory retrieval, switching between cognitive concepts, higher-level divided attention, and multitasking compared to those taking the placebo.

The study was led by Associate Professor Genevieve Steiner-Lim, a NHMRC Emerging Leadership Fellow at NICM Health Research Institute, who is optimistic about SLT's potential.

"People with mild cognitive impairment have an increased risk of dementia – over fivefold in some cases – and at the moment we do not have any approved medications for mild cognitive impairment.

"Our findings are very promising as they show that even after a relatively short treatment period of just 12-weeks, SLT can support important aspects of memory and thinking in people with mild cognitive impairment. It is also well-tolerated.

"Early intervention is critical in order to delay or prevent a dementia diagnosis," said Associate Professor Steiner-Lim.

MCI, characterized by cognitive decline, including memory and thinking difficulties, is often considered a precursor to dementia, particularly Alzheimer's disease. Currently, there are no approved pharmaceutical interventions for MCI, and existing Alzheimer's disease treatments are not considered safe or effective.

SLT is a unique herbal preparation containing standardized extracts of Panax ginseng, Ginkgo biloba, and Crocus sativus L. The herbal medicine has been developed as part of a long-standing collaboration between NICM Health Research Institute and Xiyuan Hospital, China Academy of Chinese Medical Sciences in Beijing. SLT shows promise in addressing various aspects of MCI pathophysiology, such as its anti-inflammatory, antioxidant, antiapoptotic, and cholinergic-enhancing properties, among others. Prior studies have demonstrated SLT's safety and potential cognitive benefits in vascular dementia and neurocognition in healthy adults.

The 12-week randomized, double-blind, placebo-controlled pilot phase II trial included 78 participants aged 60 years and older diagnosed with MCI. The participants were randomly assigned to receive 180 mg/day capsule of SLT or a placebo.

The results bring fresh optimism, offering a glimpse of potential treatment for the 17 per cent of people aged 60 and above worldwide who are living with MCI.

Key findings:

• Memory Improvement: After 12-weeks, participants receiving SLT demonstrated a statistically significant improvement in Logical Memory delayed recall scores compared to the placebo group.
• Enhanced Executive Function: SLT treatment improved performance in executive function tasks.
• Safety and Tolerability: SLT was well-tolerated, with a low incidence of a mild or moderate adverse events.

These findings suggest that SLT may serve as a supportive therapy for memory and executive function in people with MCI. However, further research is essential to determine the long-term benefits and understand the clinical implications, including their impact on daily functioning and quality of life.

More investment in this research is needed. The next step is to conduct another trial with a larger sample size and longer treatment period to test whether SLT can be used to treat mild cognitive impairment and potentially delay a diagnosis of dementia."

Associate Professor Genevieve Steiner-Lim, NHMRC Emerging Leadership Fellow at NICM Health Research Institute

The trial (ACTRN12617000371392) received support from funding awarded to Associate Professor Steiner-Lim from a National Health and Medical Research Council (NHMRC)-Australian Research Council (ARC) Dementia Research Development Fellowship (APP1102532) and NHMRC Investigator Grant (APP1195709). Medication and placebo were provided in-kind by Shineway Pharmaceuticals Group.