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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
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Type
Article
Citation
Steiner‐Lim, G. Z., Bensoussan, A., Andrews‐Marney, E. R., Mahmoud A. Al-Dabbas, Cave, A. E., Chiu, C. L., Christofides, K., De Blasio, F. M., Dewsbury, L. S., Fagan, N. L., Fogarty, J. S., Hattom, L. C., Hohenberg, M. I., Jafar, D., Karamacoska, D., Lim, C. K., Liu, J., Metri, N.-J., Oxenham, D. V., … Chang, D. H. (2023). 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. Alzheimer’s & Dementia: Translational Research & Clinical Interventions, 9(4), Article e12420. https://doi.org/10.1002/trc2.12420
Author
Steiner-Lim, Genevieve Z.
•
Bensoussan, Alan
•
Andrews-Marney, Elana R.
•
Mahmoud A. Al-Dabbas
•
Cave, Adele E.
•
Chiu, Christine L.
•
Christofides, Katerina
•
De Blasio, Frances M.
•
Dewsbury, Lauren S.
•
Fagan, Naomi L.
•
•
Hattom, Lena C.
•
Hohenberg, Mark I.
•
Jafar, D.
•
Karamacoska, Diana
•
Lim, Chai K.
•
Liu, Jianxun
•
Metri, Najwa-Joelle
•
Oxenham, D. Vincent
•
Ratajec, Holly
•
Roy, Nikita
•
Shipton, Danielle G.
•
Varjabedian, David
•
Chang, Dennis H.
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.
Date Issued
2023
Publisher
Wiley
Journal
Alzheimer’s & Dementia: Translational Research & Clinical Interventions
Grant ID
APP1102532
APP1195709
Funding Agency
National Health and Medical Research Council
NHMRC
Investigator
(NHMRC)
Investigator
(NHMRC)
Australian Research Council (ARC)
Dementia Research Development Fellowship
Dementia Research Development Fellowship