SaiLuoTong Shows Improvements in Memory and Executive Function in Phase 2 Trial of Mild Cognitive Impairment

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In a recent clinical trial, patients who received SaiLuoTong 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 with placebo.

Genevieve Steiner-Lim, PhD, associate professor of neuroscience and a NHMRC Emerging Leadership Fellow at Western Sydney University’s NICM Health Research Institute

Genevieve Steiner-Lim, PhD

Newly published in Alzheimer's and Dementia: Diagnosis, Assessment and Disease Monitoring, data from a phase 2 pilot trial (ACTRN12617000371392) conducted in Australia that assessed SaiLuoTong (SLT), a novel herbal extract, showed significant improvements in memory and executive function among older patients with mild cognitive impairment (MCI) with a low incidence of mild or moderate adverse events (AEs). These findings suggest that SLT is well tolerated in patients at least 60 years old and may potentially act as a supportive therapy for improving cognitive function in patients with MCI.1

After 12 weeks, the difference between groups in Logical Memory delayed recall scores with SLT and placebo was 1.40 (95% CI, 0.22-2.58; P = .010). In the same groups, the difference between groups in the Delis-Kaplan Executive Function System Trail Making Test Condition 4 switching and contrast scaled scores were 1.42 (95% CI, –0.15 to 2.99; P = .038) and 1.56 (95% CI, –0.09 to 3.20; P = .032), respectively. Notably, the Rey Auditory Verbal Learning Test delayed recall difference between the groups was 1.37 (95% CI, –0.10 to 2.84; P = .034) and 1.21 in the Functional Activities Questionnaire (95% CI, –0.21 to 2.63; P = 0.047; P <.001 after controlling for baseline scores).

"We showed that 12-weeks treatment with SLT in patients with MCI improved the retrieval of verbal information from memory and aspects of executive function including switching between cognitive concepts, higher-level divided attention, and multitasking. SLT was also safe and well tolerated," lead author Genevieve Steiner-Lim, PhD, associate professor of neuroscience and a NHMRC Emerging Leadership Fellow at Western Sydney University’s NICM Health Research Institute, told NeurologyLive®.

Clinical Takeaways

  • SaiLuoTong (SLT), a novel herbal extract, demonstrated significant cognitive improvements in older patients with mild cognitive impairment (MCI), showing promise as a supportive therapy for cognitive function.
  • The 12-week trial with SLT highlighted its potential to delay or prevent in individuals with MCI, a condition lacking approved medications.
  • Further research is needed to determine the long-term benefits and clinical implications of SLT treatment, including its impact on daily functioning and quality of life for patients with MCI.

The study enrolled 78 participants aged 60 years and older diagnosed with MCI between April 3, 2017, and February 27, 2020, who were randomly assigned to receive 180 mg/day capsule of SLT or a placebo. There were 39 patients randomized to each group (n = 78), and 65 total patients were included in the final analysis. The authors noted that this sample population of community dwellers with MCI was well characterized and homogeneous.

READ MORE: New Machine Learning Model Detects Mild Cognitive Impairment Through Retinal Images

"The findings were as we had hypothesised. SLT has been trialed as a potential treatment for vascular dementia with promising effects on cognitive function and everyday activities so we had hoped to find a similar result in our study," Steiner-Lim told. "We know that dementia risk and underlying pathology accumulates over a period of decades before there are any clinical symptoms. This is why prevention and early intervention are key. We wanted to target patients who have MCI because MCI increases dementia risk and in some cases MCI can be an early warning sign for future dementia."

In terms of safety, 22 patients (28%) experienced at least 1 AE in the duration of the trial intervention period (SLT n = 12, 15%; placebo n = 10, 13%). The authors noted that 39 AEs were reported (SLT n = 21 [54%]; placebo n = 18 [46%]) with 17 mild (44%), 20 moderate (51%) and 2 severe (5%). All told, AEs (23%) had possible causality attributed to the study treatment but only 3 (8%) were observed in the SLT group across 2 participants. Following an AE, 3 withdrew from the study, 2 of which were from the SLT group, and only 1 of had causality attributed to the study treatment because of abdominal pain and back pain.

"At the moment, we do not have any approved medications for MCI, yet we know that it is a critical window of opportunity for early intervention to potentially delay or prevent dementia. Our findings are very promising as they show that even after a relatively short period of just 12-weeks, SLT can support memory and thinking in people with MCI," Steiner-Lim told.

Investigators noted that further research is needed to determine the long-term benefits and understand the clinical implications of the treatment for patients with MCI, including its impact on daily functioning and quality of life. "More investment in this research is needed. The next step is to conduct another clinical trial with a larger sample size and longer treatment period and different doses to test whether SLT has the same positive effects on memory and thinking in patients with MCI, or whether it could potentially delay a diagnosis of dementia," Steiner-Lim told.

For more context, SLT is a unique herbal medicine that contains standardized extracts of Panax ginseng, Ginkgo biloba, and Crocus sativus L. In a statement, it was noted that this medicine has been part of a longstanding collaboration between NICM Health Research Institute and Xiyuan Hospital of the China Academy of Chinese Medical Sciences in Beijing. According to previous research, SLT demonstrated positive safety and potential cognitive benefits in patients with vascular dementia and neurocognition in healthy adults.3,4 Thus, this therapy shows potential for addressing various aspects in MCI pathophysiology including anti-inflammatory, antioxidant, antiapoptotic, and cholinergic enhancing properties, among others.

REFERENCES
1. Steiner-Lim GZ, Bensoussan A, Andrews-Marney ER, et al. A randomized, double-blind, placebo-controlled, parallel-group 12-week pilot phase II trial of SaiLuoTong (SLT) for cognitive function in older adults with mild cognitive impairment. Alzheimers Dement (N Y). 2023;9(4):e12420. Published 2023 Oct 11. doi:10.1002/trc2.12420
2. Significant Development in Mild Cognitive Impairment Treatment Revealed in Australia. News Release. Western Sydney University. Published October 11, 2023. Accessed October 16, 2023.https://www.westernsydney.edu.au/newscentre/news_centre/more_news_stories/significant_development_in_mild_cognitive_impairment_treatment_revealed_in_australia
3. Karamacoska D, Chan DKY, Leung I, et al. Study protocol for a phase III randomised controlled trial of SaiLuoTong (SLT) for vascular dementia and Alzheimer's disease with cerebrovascular disease. PLoS One. 2023;18(3):e0265285. Published 2023 Mar 15. doi:10.1371/journal.pone.0265285
4. Steiner GZ, Yeung A, Liu JX, et al. The effect of SaiLuoTong (SLT) on neurocognitive and cardiovascular function in healthy adults: a randomised, double-blind, placebo controlled crossover pilot trial. BMC Complement Altern Med. 2016;16:15. Published 2016 Jan 13. doi:10.1186/s12906-016-0989-0
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