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Trial registered on ANZCTR


Registration number
ACTRN12617000945325
Ethics application status
Approved
Date submitted
17/06/2017
Date registered
30/06/2017
Date last updated
9/03/2020
Date data sharing statement initially provided
9/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of a Herbal and Nutritional Supplement on Cognitive Function in Older Adults with Subjective Cognitive Impairment
Scientific title
A 6 month clinical trial of the efficacy and safety of Cognition Support Formulation (BioCeuticals) on cognitive function in older adults with subjective cognitive impairment.
Secondary ID [1] 291871 0
None
Universal Trial Number (UTN)
U1111-1196-9548
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subjective Cognitive Impairment (SCI) 303275 0
Condition category
Condition code
Mental Health 302968 302968 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Double-blind, randomised placebo controlled trial.
Participants will be randomised into either the placebo or active treatment groups and complete a battery of neuropsychological and psychophysiological tasks over a 6 month period.
Active treatment is 1 tablet taken twice daily of Cognition Support Formula (Bioceuticals).
Each active tablet contains: Bacopa monnieri (bacopa whole plant) 4g, Ginkgo biloba (ginkgo leaf) 3g, Panax ginseng (Korean ginseng root) 212mg, R, S alpha-lipoic acid 300mg

Intervention code [1] 298274 0
Treatment: Other
Comparator / control treatment
Placebo tablet (1 taken twice daily) is matched on colour, taste, smell and size to that of the active tablet.
Control group
Placebo

Outcomes
Primary outcome [1] 302356 0
To determine the efficacy of 6 months treatment with Cognition Support Formula to improve cognition in older adults with Subjective Cognitive Impairment as measured by the CogState Pre-Clinical Alzheimer's battery.
Timepoint [1] 302356 0
Baseline (0 months), midpoint (3 months) and endpoint (6 months).
Secondary outcome [1] 335702 0
To assess the safety and adverse effects of Cognition Support Formula compared to placebo at baseline (0 months), midpoint (3 months) and endpoint (6 months).
Separately, minor adverse effects have been reported for brahmi, ginseng and Alpha-lipoic acid including: minor gastrointestinal upset and insomnia, compared to placebo. Participants will complete a diary and will document any adverse effects throughout the course of the study. Adverse effects will be discussed with participants at each midpoint, endpoint and 4 weeks after endpoint sessions.
Timepoint [1] 335702 0
Baseline (0 months), midpoint (3 months) and endpoint (6 months).
Secondary outcome [2] 335703 0
To assess the efficacy of 6-months treatment (at 3 different time-points: baseline, midpoint and endpoint) of Cognition Support Formula compared to placebo on mood, as measured by the Depression, Anxiety, Stress Scale (DASS-42).
Timepoint [2] 335703 0
Baseline (0 months), midpoint (3 months) and endpoint (6 months).
Secondary outcome [3] 335704 0
To assess the efficacy of a 6-month treatment of Cognition Support Formula on neurocognition compared to placebo by utilising psychophysiological measures (EEG) at baseline and endpoint. EEG will provide objective information pertaining to the mechanisms of action of Cognition Support Formula and the neuronal substrates of cognition in older adults with SCI. EEG participants (30 in total) will be matched on sex and age. Half will be derived from the active group, and half from the placebo group. Participants will be recruited for all procedures including EEG until the quota for the EEG component has been reached.
Timepoint [3] 335704 0
Baseline (0 months) and endpoint (6 months).
Secondary outcome [4] 336331 0
To assess the efficacy of 6-months treatment of Cognition Support Formula compared to placebo on mood, as measured by the Short Health Anxiety Inventory (SHAI).
Timepoint [4] 336331 0
Baseline (0 months), midpoint (3 months) and endpoint (6 months).
Secondary outcome [5] 336332 0
To assess the efficacy of 6-months treatment of Cognition Support Formula compared to placebo on fatigue and energy levels, as measured by the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F).
Timepoint [5] 336332 0
Baseline (0 months), midpoint (3 months) and endpoint (6 months).

Eligibility
Key inclusion criteria
1. No diagnosis of dementia or Mild Cognitive Impairment (MCI).
2. Evidence of SCI as measured by:
Answering ‘yes’ to any of the following questions:
-Do you feel your memory and thinking is getting worse?
-Do you feel your memory and thinking has become worse over the past 2-3 years?
-Are you concerned about your decline in memory and thinking?
3. Scoring (greater than or equal to) 23 on the Montreal Cognitive Assessment (MoCA).
4. Normal vision or corrected to normal.
5. Normal hearing or aided.
6. Provide informed consent.
Minimum age
60 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Depression, as measured by the 30-item Geriatric Depression Scale (GDS); Participants scoring (greater than or equal to) 19 will be excluded.
2. Use of antidepressants/anxiolytics (if participants have been taking these, a 16-week washout is required, but only if this was the intended course of action from their usual care)
3. Use of psychoactive medications, alcohol intake (maximum of 14 standard drinks per week) as recommended by the Australian Department of Health.
4. No caffeine 2 hours prior to testing, and non-smokers.
5. No history of seizures or head injury (with loss of consciousness).
6. Allergy to study drug ingredients: ginseng, ginkgo, brahmi, or alpha-lipoic acid.
7. Participants taking the following ingredients: Bacopa monnieri (brahmi), Ginkgo biloba, Panax ginseng or alpha-lipoic acid (either separately or as a component of a supplement), are excluded from participation unless they have discontinued using these ingredients 8 weeks prior to testing.
8. Left-handedness, only for EEG testing.
9. Type 2 diabetics with a high fasting glucose level at baseline (>8 mmol/L, according to Diabetes Australia) or diabetics experiencing complications associated with their diabetes.
10. Diagnosed psychiatric disorders including: bipolar disorder, schizophrenia, personality disorders, drug and alcohol dependence or substance abuse disorders.
11. Presence or history of severe renal and hepatic disorders.
12. High dependence on medical care (including medications) due to past or current medical conditions (chronic illness), for example; cancer. Participants using Cyclophosphamide and Levothyroxine will be excluded.

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)
An external staff member to the research team will send the random sequence directly to the trial drug manufacturer, with participant IDs and unique batch codes that will be used to conceal the sequence. This is a double-blind trial, so both participants and the research team will be blinded to allocation until study completion.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated at a 1:1 ratio to either the treatment or placebo group using a permuted block allocation strategy. Computerised randomisation and allocation will be conducted using a unique random number generator in Microsoft Excel by a University staff member external to the research team. After eligibility is confirmed, participants will then be allocated to the next participant ID/numbered box of product by a member of the research team.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The study will employ a mixed-model design with a between-subjects factor of group: (treatment vs. placebo), and within-subjects factor of time (baseline vs. midpoint vs. endpoint). Mixed-model ANOVAs will be conducted to assess differences in continuous outcome measures, with simple planned contrasts conducted in order to assess all time points: baseline vs. midpoint, midpoint vs. endpoint and baseline vs. endpoint. A significant group × time interaction will be required to determine treatment efficacy on the primary outcome measure. Bonferroni corrections for multiple comparisons will be applied to any non-planned contrasts. MANOVAs, Principal Components Analysis (PCA), and Pearson’s correlations will also be utilised for psychophysiological data assessment. The primary outcome measure to be assessed is the change in scores from each of the CogState® tasks, and the secondary outcomes are: the changes in DASS-42, SHAI and FACIT-F scores, and changes neuronal and physiological activity. An alpha level of < .05 will be used to determine statistical significance.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 29604 0
2145 - Westmead
Recruitment postcode(s) [2] 16351 0
2500 - Wollongong
Recruitment postcode(s) [3] 16352 0
2560 - Campbelltown
Recruitment postcode(s) [4] 16354 0
2567 - Narellan
Recruitment postcode(s) [5] 16353 0
2570 - Camden

Funding & Sponsors
Funding source category [1] 296373 0
Commercial sector/Industry
Name [1] 296373 0
BioCeuticals pty ltd
Address [1] 296373 0
Unit 1/ Level 1, 85 O'Riordan St
Alexandria 2015
New South Wales Australia
Country [1] 296373 0
Australia
Primary sponsor type
Individual
Name
Mrs Adele Cave
Address
The National Institute of Complementary Medicine
Building 5,  Campbelltown Campus
Western Sydney University
Locked Bag 1797
Penrith  NSW  2751
Australia
Country
Australia
Secondary sponsor category [1] 295772 0
University
Name [1] 295772 0
Western Sydney University (The National Institute of Complementary Medicine)
Address [1] 295772 0
The National Institute of Complementary Medicine
Building 5,  Campbelltown Campus
Western Sydney University
Locked Bag 1797
Penrith  NSW  2751
Australia
Country [1] 295772 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297610 0
Western Sydney University Human Research Ethics Committee (EC00314)
Ethics committee address [1] 297610 0
Western Sydney University
Research Engagement, Development and Innovation (REDI)
Locked Bag 1797
Penrith NSW 2751
Ethics committee country [1] 297610 0
Australia
Date submitted for ethics approval [1] 297610 0
14/11/2016
Approval date [1] 297610 0
02/02/2017
Ethics approval number [1] 297610 0
H11958

Summary
Brief summary
The aim of the proposed study is to test the efficacy of a herbal and nutritional supplement
(BioCeuticals Pty Ltd Cognition Support Formula) in a sample of older adults who report
Subjective Cognitive Impairment (SCI). The proposed study is a 6 month randomised double blind placebo controlled trial which will test the effects of cognition support formula on cognition (CogState), mood, fatigue, electrophysiology and autonomic function in older adults with SCI. Participants will undergo telephone and face to face screening in order to determine if they meet the criteria for participation. During the telephone screening, participants will respond to questions from a cognitive status questionnaire (TICS-M). General health and depression questionnaires will be administered during the face to face screening. At baseline (0 months), midpoint (3 months) and endpoint (6 months) participants will complete a series of mood, fatigue and cognitive tests (both computerised and pen and paper tests).Opportunities will be made available for participants to additionally take part in Electroencephalography (EEG) testing at baseline and endpoint. These measures will enable a greater capacity to determine the efficacy of cognition support formula on cognitive health in older adults with SCI.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74578 0
Mrs Adele Cave
Address 74578 0
The National Institute of Complementary Medicine
Building 5,  Campbelltown Campus
Western Sydney University
Locked Bag 1797
Penrith  NSW  2751
Australia
Country 74578 0
Australia
Phone 74578 0
+61 487 472 273
Fax 74578 0
Email 74578 0
A.Cave@westernsydney.edu.au
Contact person for public queries
Name 74579 0
Mrs Adele Cave
Address 74579 0
The National Institute of Complementary Medicine
Building 5,  Campbelltown Campus
Western Sydney University
Locked Bag 1797
Penrith  NSW  2751
Australia
Country 74579 0
Australia
Phone 74579 0
+61 487 472 273
Fax 74579 0
Email 74579 0
A.Cave@westernsydney.edu.au
Contact person for scientific queries
Name 74580 0
Mrs Adele Cave
Address 74580 0
The National Institute of Complementary Medicine
Building 5,  Campbelltown Campus
Western Sydney University
Locked Bag 1797
Penrith  NSW  2751
Australia
Country 74580 0
Australia
Phone 74580 0
+61 487 472 273
Fax 74580 0
Email 74580 0
A.Cave@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
Data will be de-identified and will not be published as individual outcomes but rather comparisons between groups e.g. Placebo vs. treatment, baseline vs. midpoint vs. endpoint, male vs. female.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 7288 0
Study protocol
Citation [1] 7288 0
Cave, A. E., Chang, D., Muench, G.W., & Steiner, G.Z. (2019). Efficacy of Cognition Support Formula® on cognitive function in older adults with subjective cognitive impairment: a protocol for a 26-week, randomised, double-blind, placebo-controlled trial. Trials, 20(345). doi:10.1186/s13063-019-3431-3
Link [1] 7288 0
Email [1] 7288 0
Other [1] 7288 0
Summary results
No Results