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

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  1   2 , Alan Bensoussan  1 , Elana R Andrews-Marney  1 , Mahmoud A Al-Dabbas  1 , Adele E Cave  1 , Christine L Chiu  3 , Katerina Christofides  1 , Frances M De Blasio  1 , Lauren S Dewsbury  1 , Naomi L Fagan  1 , Jack S Fogarty  4 , Lena C Hattom  1 , Mark I Hohenberg  5 , Deyyan Jafar  1   3 , Diana Karamacoska  1   2 , Chai K Lim  3 , Jianxun Liu  6 , Najwa-Joelle Metri  1 , D Vincent Oxenham  7   8 , Holly Ratajec  1 , Nikita Roy  1 , Danielle G Shipton  1 , David Varjabedian  1   5 , Dennis H Chang  1
Affiliations

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 et al. Alzheimers Dement (N Y). .

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.

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Conflict of interest statement

As a medical research institute, NICM Health Research Institute 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 declared. Author disclosures are available in the supporting information.

Figures

FIGURE 1
FIGURE 1
Schematic of participant flow including number of participants at each stage of the trial. AE, adverse event; SLT, SaiLuoTong.
FIGURE 2
FIGURE 2
Statistically significant outcomes from the mean difference data shown in Table 2 are visualized here using line charts showing the separate means and standard errors for each group (SaiLuoTong [SLT] = blue; placebo = orange) and timepoint (baseline and endpoint). Outcome measures include: Wechsler Memory Scale Fourth Edition Logical Memory delayed recall score (A), Delis–Kaplan Executive Function System Trail Making Test condition 4 switching (B) and contrast (C) scaled scores, Rey Auditory Verbal Learning Test delayed recall score (D), and Functional Activities Questionnaire (FAQ; E) scores. * Denotes P < 0.05 for FAQ scores at baseline.
See this image and copyright information in PMC

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