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

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 RatajecNikita Roy, Danielle G. Shipton, David Varjabedian, Dennis H. Chang

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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.

Original language	English
Article number	e12420
Pages (from-to)	1-11
Number of pages	11
Journal	Alzheimer's and Dementia: Translational Research and Clinical Interventions
Volume	9
Issue number	4
DOIs	https://doi.org/10.1002/trc2.12420
Publication status	Published - 11 Oct 2023

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Copyright the Author(s) 2023. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Keywords

Alzheimer's disease
clinical trial
cognitive function
mild cognitive impairment
SaiLuoTong

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Steiner-Lim, G. Z., Bensoussan, A., Andrews-Marney, E. R., Al-Dabbas, M. A., 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 and Dementia: Translational Research and Clinical Interventions, 9(4), 1-11. Article e12420. https://doi.org/10.1002/trc2.12420

Steiner-Lim, Genevieve Z. ; Bensoussan, Alan ; Andrews-Marney, Elana R. 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. In: Alzheimer's and Dementia: Translational Research and Clinical Interventions. 2023 ; Vol. 9, No. 4. pp. 1-11.

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title = "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",

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.",

keywords = "Alzheimer's disease, clinical trial, cognitive function, mild cognitive impairment, SaiLuoTong",

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

note = "Copyright the Author(s) 2023. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.",

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doi = "10.1002/trc2.12420",

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Steiner-Lim, GZ, Bensoussan, A, Andrews-Marney, ER, Al-Dabbas, MA, Cave, AE, Chiu, CL, Christofides, K, De Blasio, FM, Dewsbury, LS, Fagan, NL, Fogarty, JS, Hattom, LC, Hohenberg, MI, Jafar, D, Karamacoska, D, Lim, CK, Liu, J, Metri, N-J, Oxenham, DV, Ratajec, H, Roy, N, Shipton, DG, Varjabedian, D & Chang, DH 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 and Dementia: Translational Research and Clinical Interventions, vol. 9, no. 4, e12420, pp. 1-11. https://doi.org/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. / Steiner-Lim, Genevieve Z.; Bensoussan, Alan; Andrews-Marney, Elana R. et al.
In: Alzheimer's and Dementia: Translational Research and Clinical Interventions, Vol. 9, No. 4, e12420, 11.10.2023, p. 1-11.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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

AU - Steiner-Lim, Genevieve Z.

AU - Bensoussan, Alan

AU - Andrews-Marney, Elana R.

AU - Al-Dabbas, Mahmoud A.

AU - Cave, Adele E.

AU - Chiu, Christine L.

AU - Christofides, Katerina

AU - De Blasio, Frances M.

AU - Dewsbury, Lauren S.

AU - Fagan, Naomi L

AU - Fogarty, Jack S.

AU - Hattom, Lena C.

AU - Hohenberg, Mark I.

AU - Jafar, Deyyan

AU - Karamacoska, Diana

AU - Lim, Chai K.

AU - Liu, Jianxun

AU - Metri, Najwa-Joelle

AU - Oxenham, D. Vincent

AU - Ratajec, Holly

AU - Roy, Nikita

AU - Shipton, Danielle G.

AU - Varjabedian, David

AU - Chang, Dennis H.

N1 - Copyright the Author(s) 2023. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

PY - 2023/10/11

Y1 - 2023/10/11

N2 - 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.

AB - 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.

KW - Alzheimer's disease

KW - clinical trial

KW - cognitive function

KW - mild cognitive impairment

KW - SaiLuoTong

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U2 - 10.1002/trc2.12420

DO - 10.1002/trc2.12420

M3 - Article

C2 - 37830013

SN - 2352-8737

VL - 9

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JO - Alzheimer's and Dementia: Translational Research and Clinical Interventions

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ER -

Steiner-Lim GZ, Bensoussan A, Andrews-Marney ER, Al-Dabbas MA, Cave AE, Chiu CL 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. Alzheimer's and Dementia: Translational Research and Clinical Interventions. 2023 Oct 11;9(4):1-11. e12420. 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

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