ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000371392

Ethics application status

Approved

Date submitted

8/03/2017

Date registered

10/03/2017

Date last updated

11/08/2023

Date data sharing statement initially provided

26/03/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Sailuotong (SLT): A standardised herbal medicine formula for cognitive function in people with mild cognitive impairment

Scientific title

A randomised, double-blind, placebo-controlled 12 week trial of Sailuotong (SLT) for cognitive function in people with mild cognitive impairment

Secondary ID [1]

NIL

Universal Trial Number (UTN)

U1111-1193-7674

Trial acronym

MCISLT

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Mild cognitive impairment

Condition category

Condition code

Neurological

Other neurological disorders

Alternative and Complementary Medicine

Herbal remedies

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

12 weeks 180 mg/day (2 x 45 mg oral capsules each morning and night) SLT formula (81.84 mg ginsenosides, 81.84 mg total ginkgo flavone-glycosides, 16.36 mg crocins).

Each SLT capsule contains a 45 mg standardised mixture of 20.46 mg ginsenosides extracted from Panax ginseng, 20.46 mg total ginkgo flavone-glycosides extracted from Ginkgo biloba, and 4.09 mg crocins extracted from Crocus sativa.

Adherence will be assessed via medication diaries, and collecting any unused tablets and midpoint and endpoint.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

12 weeks 180 mg/day (2 x 45 mg oral capsules each morning and night) starch placebo containing inert substances matched for the colour, taste, and smell of SLT.

Control group

Placebo

Outcomes

Primary outcome [1]

Change in Logical Memory Story A - Delayed Recall score

Timepoint [1]

Assessed at baseline (week 0) and endpoint (week 12)

Primary outcome [2]

Change in D-KEFS Trail Making Test Condition 4 score

Timepoint [2]

Assessed at baseline (week 0) and endpoint (week 12)

Primary outcome [3]

Change in Digit Symbol Coding score

Timepoint [3]

Assessed at baseline (week 0) and endpoint (week 12)

Secondary outcome [1]

Change in Block Design score

Timepoint [1]

Assessed at baseline (week 0) and endpoint (week 12)

Secondary outcome [2]

Change in Digit Span score

Timepoint [2]

Assessed at baseline (week 0) and endpoint (week 12)

Secondary outcome [3]

Change in D-KEFS Trail Making Test Condition 2 score

Timepoint [3]

Assessed at baseline (week 0) and endpoint (week 12)

Secondary outcome [4]

Change in Rey Auditory Verbal Learning Test (RAVLT) score

Timepoint [4]

Assessed at baseline (week 0) and endpoint (week 12)

Secondary outcome [5]

Change in Rey Complex Figure Test score

Timepoint [5]

Assessed at baseline (week 0) and endpoint (week 12)

Secondary outcome [6]

Change in Benton Visual Retention Test score

Timepoint [6]

Assessed at baseline (week 0) and endpoint (week 12)

Secondary outcome [7]

Change in 15-item Boston Naming Test score

Timepoint [7]

Assessed at baseline (week 0) and endpoint (week 12)

Secondary outcome [8]

Change in Semantic Fluency test score

Timepoint [8]

Assessed at baseline (week 0) and endpoint (week 12)

Secondary outcome [9]

Change in Controlled Oral Word Association Test score

Timepoint [9]

Assessed at baseline (week 0) and endpoint (week 12)

Secondary outcome [10]

Mechanisms of action of SLT will be assessed using electroencephalograph (EEG) at rest and in response to audio/visual stimuli to index changes in neurophysiological processes

Timepoint [10]

Assessed at baseline (week 0) and endpoint (week 12)

Secondary outcome [11]

Mechanisms of action of SLT will be assessed using autonomic measures of skin conductance and electrocardiograph (ECG) at rest and in response to audio/visual stimuli to index changes in psychophysiological processes

Timepoint [11]

Assessed at baseline (week 0) and endpoint (week 12)

Secondary outcome [12]

Mechanisms of action of SLT will be assessed via change in serum inflammatory marker concentrations including IL-6, IL-1beta, and TNF-alpha.

Timepoint [12]

Assessed at baseline (week 0) and endpoint (week 12)

Secondary outcome [13]

Mechanisms of action of SLT will be assessed via change in cerebral blood flow measured by common carotid artery ultrasound

Timepoint [13]

Assessed at baseline (week 0) and endpoint (week 12)

Secondary outcome [14]

Montreal Cognitive Assessment (MoCA)

Timepoint [14]

Assessed at baseline (week 0) and endpoint (week 12)

Secondary outcome [15]

Logical Memory Story A - Immediate Recall

Timepoint [15]

Assessed at baseline (week 0) and endpoint (week 12)

Secondary outcome [16]

Functional Activities Questionnaire (FAQ)

Timepoint [16]

Assessed at baseline (week 0) and endpoint (week 12)

Secondary outcome [17]

Quality of Life in Alzheimer's Disease scale (QoL-AD)

Timepoint [17]

Assessed at baseline (week 0) and endpoint (week 12)

Secondary outcome [18]

21-item Depression, Anxiety, Stress Scale (DASS-21)

Timepoint [18]

Assessed at baseline (week 0) and endpoint (week 12)

Eligibility

Key inclusion criteria

Greater than or equal to 60 years of age
No diagnosis of dementia
Confirmed diagnosis of MCI due to Alzheimer’s disease core clinical criteria according to the National Institute on Aging-Alzheimer’s Association (NIA-AA) working group guidelines (Albert et al., 2011)
No severe depression by scoring less than or equal to 19 on the Geriatric Depression Scale (GDS)
Agreement to take part in the study as evidenced by a personally signed and dated informed consent document

Albert, M.S., et al., The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement, 2011. 7(3): p. 270-9.

Minimum age

60 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

Less than 60 years of age
Diagnosis of psychiatric disorder(s) including: dissociative disorder, obsessive-compulsive disorder, personality disorder, schizophrenia, bipolar disorder
History of drug and alcohol dependence or substance-related disorders
History of seizures
Head trauma with loss of consciousness
Left-handedness measured by scoring less than 0 on the Edinburgh Handedness Inventory
Allergy to at least 1 ingredient of SLT (Ginkgo biloba, Panax ginseng, or Crocus sativus)
Current use of supplements containing Ginkgo biloba, Panax ginseng, or Crocus sativus (8 week washout period required)
History of several renal and hepatic disorders

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation will be concealed using batch numbers generated using a unique random number generator in Microsoft Excel by a University staff member external to the research team. A series of 8 batches numbers will be used (4 for each arm), and sent directly to the drug manufacturer. After eligibility is confirmed, participants will then be allocated to the next numbered box of product by a member of the research team.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computerised random sequence allocation conducted using a unique random number generator in Microsoft Excel by a University staff member external to the research team. A permuted block randomisation strategy will be used with an allocation ratio of 1:1.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 2

Type of endpoint/s

Efficacy

Statistical methods / analysis

There are no similar studies using SLT for the proposed study duration (12 weeks) in an MCI cohort. Thus, we selected a well-designed study that used the same primary outcome measure and a similar cohort with a 16 week intervention. That study also provided effect sizes at midpoint (8 weeks; Craft et al., 2012) and demonstrated significantly improved delayed story recall on the Logical Memory Story-A subtest of the WMS-IV following 8 weeks of 20 IU insulin: a treatment group × time interaction, p = .02, Cohen’s f = .36.

We utilised this effect size to conduct a simple a priori sample size calculation based on the Logical Memory Story-A subtest of the WMS-IV. To detect an effect size of Cohen’s f = .36, at a = .05 and 80 % power, 63 participants across 2 groups are required. Allowing for a 20% drop out, this means 76 participants (38 per group) are required. This was rounded-up to 80 (40 per arm) to facilitate the permuted block randomisation strategy. This study is also a pilot efficacy study, so a larger sample size to reach a higher degree of statistical power is not required.

Craft, S., et al., Intranasal Insulin Therapy for Alzheimer Disease and Amnestic Mild Cognitive Impairment. Archives of Neurology, 2012. 69(1): p. 29-38.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

3/04/2017

Actual

3/04/2017

Date of last participant enrolment

Anticipated

30/08/2019

Actual

25/02/2020

Date of last data collection

Anticipated

30/11/2019

Actual

8/05/2020

Sample size

Target

80

Accrual to date

Final

79

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC-ARC Dementia Research Development Fellowship (GNT1102532)

Address [1]

GHD Building Level 1
16 Marcus Clarke St
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

Western Sydney University

Address

Locked Bag 1797
Penrith NSW 2751

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Sydney University Human Research Ethics Committee

Ethics committee address [1]

Locked Bag 1797
Penrith NSW 2751

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/09/2016

Approval date [1]

30/11/2016

Ethics approval number [1]

H11878

Summary

Brief summary

Mild cognitive impairment (MCI) causes a slight but noticeable decline in cognitive abilities, and is conceptualised as a transitional prodromal stage between healthy ageing and dementia.  It is estimated that up to 35 % of Australians aged 70 and older have MCI, and 15 % of those individuals will go on to develop dementia within a year.  Currently, there are no treatment options for MCI, and anti-dementia pharmaceuticals are largely ineffective as they act on a single therapeutic target, which does not address the multifaceted pathophysiology of MCI.  

The project aims to evaluate the mechanisms of action and test the efficacy and safety of a novel multi-target treatment for MCI due to Alzheimer's disease: Sailuotong (SLT), a standardised herbal medicine formula.  SLT capitalises on the multi-system approach of Chinese herbal medicine, containing multiple standardised active components including Panax ginseng, Ginkgo biloba, and Crocus sativus (saffron), and has already shown promise as a potential treatment for vascular dementia. 

This project will involve a 12 week randomised, double-blind, placebo-controlled trial of 180 mg/day SLT for cognitive function in people with MCI due to Alzheimer's disease.  The co-primary outcome measures are episodic memory as measured by Logical Memory Story A - Delayed Recall, perceptual processing speed as measured by Digit Symbol Coding, and executive function as measured by the D-KEFS (Delis-Kaplan Executive Function System) Trail Making Test Condition 4 and the Rey Complex Figure Test (RCFT).

Secondary outcome measures include: the Montreal Cognitive Assessment (MoCA), Block Design, Digit Span, Logical Memory Story A - Immediate Recall, D-KEFS Trail Making Test Condition 2, Rey Auditory Verbal Learning Test (RAVLT), Benton Visual Retention Test, 15-item Boston Naming Test, Semantic Fluency, the Controlled Oral Word Association Test, the Functional Activities Questionnaire (FAQ), Quality of Life in Alzheimer's Disease scale (QoL-AD), and the 21-item Depression, Anxiety, Stress Scale (DASS-21).

We will also examine the mechanisms of action of SLT in people with MCI by assessing brain activity via electroencephalograph (EEG), autonomic activity via skin conductance and electrocardiograph (ECG), cerebral blood flow via carotid artery ultrasound, and serum inflammatory markers including IL-6, IL-1beta, and TNF-alpha.

Trial website

http://nicm.edu.au/research/clinical_trials/mci_slt_trial_study

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/372483-H11878 - Human Ethics Approval - Nov 2016.pdf (Ethics approval)

Contacts

Principal investigator

Name

A/Prof Genevieve Steiner

Address

NICM, Western Sydney University
Locked Bag 1797
Penrith NSW 2751

Country

Australia

Phone

+61 2 9685 4761

Fax

+61 2 9685 4760

Email

g.steiner@westernsydney.edu.au

Contact person for public queries

Name

Genevieve Steiner

Address

NICM, Western Sydney University
Locked Bag 1797
Penrith NSW 2751

Country

Australia

Phone

+61 2 9685 4761

Fax

+61 2 9685 4760

Email

g.steiner@westernsydney.edu.au

Contact person for scientific queries

Name

Genevieve Steiner

Address

NICM, Western Sydney University
Locked Bag 1797
Penrith NSW 2751

Country

Australia

Phone

+61 2 9685 4761

Fax

+61 2 9685 4760

Email

g.steiner@westernsydney.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No

No/undecided IPD sharing reason/comment

The ethics approval for this study involved the presentation and reporting of aggregated de-identified participant data only.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1735	Study protocol					372483-(Uploaded-26-03-2019-12-25-25)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Study protocol for a randomised, double-blind, placebo-controlled 12-week pilot phase II trial of Sailuotong (SLT) for cognitive function in older adults with mild cognitive impairment.	2018	https://dx.doi.org/10.1186/s13063-018-2912-0
Embase	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.	2023	https://dx.doi.org/10.1002/trc2.12420

N.B. These documents automatically identified may not have been verified by the study sponsor.