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

Genevieve Z Steiner-Lim; Alan Bensoussan; Elana R Andrews-Marney; Mahmoud A Al-Dabbas; Adele E Cave; Christine L Chiu; Katerina Christofides; Frances M De Blasio; Lauren S Dewsbury; Naomi L Fagan; Jack S Fogarty; Lena C Hattom; Mark I Hohenberg; Deyyan Jafar; Diana Karamacoska; Chai K Lim; Jianxun Liu; Najwa-Joelle Metri; D Vincent Oxenham; Holly Ratajec; Nikita Roy; Danielle G Shipton; David Varjabedian; Dennis H Chang

doi:10.1002/trc2.12420

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 Oct 11;9(4):e12420. doi: 10.1002/trc2.12420. eCollection 2023 Oct-Dec.

Authors

Genevieve Z Steiner-Lim^{1

2}, Alan Bensoussan¹, Elana R Andrews-Marney¹, Mahmoud A Al-Dabbas¹, Adele E Cave¹, Christine L Chiu³, Katerina Christofides¹, Frances M De Blasio¹, Lauren S Dewsbury¹, Naomi L Fagan¹, Jack S Fogarty⁴, Lena C Hattom¹, Mark I Hohenberg⁵, Deyyan Jafar^{1

3}, Diana Karamacoska^{1

2}, Chai K Lim³, Jianxun Liu⁶, Najwa-Joelle Metri¹, D Vincent Oxenham^{7

8}, Holly Ratajec¹, Nikita Roy¹, Danielle G Shipton¹, David Varjabedian^{1

5}, Dennis H Chang¹

Affiliations

¹ NICM Health Research Institute Western Sydney University Penrith New South Wales Australia.
² Translational Health Research Institute (THRI) Western Sydney University Penrith New South Wales Australia.
³ Macquarie Medical School Macquarie University Macquarie Park New South Wales Australia.
⁴ Science of Learning in Education Centre National Institute of Education Nanyang Technological University Singapore.
⁵ School of Medicine Western Sydney University Penrith New South Wales Australia.
⁶ Xiyuan Hospital China Academy of Chinese Medical Sciences Beijing PR China.
⁷ Neuropsychology Department Royal North Shore Hospital St. Leonards New South Wales Australia.
⁸ School of Psychological Sciences, Faculty of Medicine, Health and Human Sciences Macquarie University Macquarie Park New South Wales Australia.

Abstract

Introduction: This study primarily aimed to evaluate the efficacy and safety of SaiLuoTong (SLT) on cognition in mild cognitive impairment (MCI).

Methods: Community-dwelling people with MCI aged ≥60 years were randomly assigned to 180 mg/day SLT or placebo for 12 weeks.

Results: Thirty-nine participants were randomized to each group (N = 78); 65 were included in the final analysis. After 12 weeks, the between-groups difference in Logical Memory delayed recall scores was 1.40 (95% confidence interval [CI]: 0.22 to 2.58; P = 0.010); 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 = 0.038) and 1.56 (95% CI: -0.09 to 3.20; P = 0.032), respectively; Rey Auditory Verbal Learning Test delayed recall was 1.37 (95% CI: -0.10 to 2.84; P = 0.034); and Functional Activities Questionnaire was 1.21 (95% CI: -0.21 to 2.63; P = 0.047; P < 0.001 after controlling for baseline scores).

Discussion: SLT is well tolerated and may be useful in supporting aspects of memory retrieval and executive function in people with MCI.

Highlights: SaiLuoTong (SLT) improves delayed memory retrieval and executive function in people with mild cognitive impairment (MCI).SLT is well tolerated in people ≥ 60 years.The sample of community dwellers with MCI was well characterized and homogeneous.

Keywords: Alzheimer's disease; SaiLuoTong; clinical trial; cognitive function; mild cognitive impairment.