Evidence map›Paper›PMID 31182153›Full record

ArticleTrials2019

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.

Adele E Cave, Dennis H Chang, Gerald W Münch, Genevieve Z Steiner

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.8field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Mild Cognitive Impairment and Mild Dementia: The Role ofPharmaceuticals (Basel, Switzerland) · 2021
    Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

Adele E CaveNICM Health Research Institute, Western Sydney University, Locked Bag 1797, Penrith, NSW, 2751, Australia.
Dennis H ChangNICM Health Research Institute, Western Sydney University, Locked Bag 1797, Penrith, NSW, 2751, Australia.
Gerald W MünchNICM Health Research Institute, Western Sydney University, Locked Bag 1797, Penrith, NSW, 2751, Australia.
Genevieve Z SteinerNICM Health Research Institute, Western Sydney University, Locked Bag 1797, Penrith, NSW, 2751, Australia. G.Steiner@westernsydney.edu.au.ORCID http://orcid.org/0000-0002-8708-6104
Western Sydney University · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDue to an ageing population in Australia there has been an increase in the number of older adults with subjective cognitive impairment (SCI), a self-reported decline in cognitive function associated with an increased risk of mild cognitive impairment and dementia. There is no current, recommended treatment for SCI; therefore, the effectiveness of a supplement approved by the Therapeutic Goods Association that has the potential to enhance cognitive function in an at-risk cohort should be tested. The primary aim of this proposed research is to determine the efficacy of 6 months of treatment with BioCeuticals Cognition Support Formula® (containing Bacopa monniera (brahmi), Ginkgo biloba, Panax ginseng and alpha-lipoic acid) on cognition in older adults with SCI (utilising the CogState® one card learning and identification tests as co-primary outcome measures of visual short-term memory and attention; mean speed (ms), accuracy (%), and total number of hits, misses, and anticipations) compared with placebo. The secondary aims are to assess an improvement in other cognitive domains (executive functioning, processing speed, and working memory), evaluate safety, adverse effects, and determine efficacy on mood, fatigue, and neurocognition. It is expected that improvements across the study timepoints in the co-primary outcomes in the active treatment group (compared with placebo) will be evident.

methodOne-hundred and twenty participants will be recruited for the randomised, double-blind, placebo-controlled study. Participants will be randomly assigned to one of the treatment groups (active or placebo) at a 1:1 ratio, and will be required to complete a series of cognitive (using CogState®), mood (using the Depression, Anxiety, Stress Scale (DASS-42) and Short Health Anxiety Inventory (SHAI)), and fatigue (using the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F)) tasks at baseline (0 months), the midpoint (3 months), and the endpoint (6 months). These tasks will be evaluated between timepoints (baseline vs. midpoint, midpoint vs. endpoint, and baseline vs. endpoint). Neurocognition will be measured by electroencephalography at baseline and at the endpoint in half of the participants. Adverse effects will be documented over the 6-month trial period. DISCUSSION: This is the first study to test the efficacy of Cognition Support Formula® on cognition in older adults with SCI. As people with SCI have an increased risk of dementia, and there are limited treatments options for this population, it is important to assess a supplement that has the potential to enhance cognitive function.

trial registrationUniversal Trial Number (UTN), U1111-1196-9548. Australian New Zealand Clinical Trials Registry, ACTRN12617000945325 . Registered on 30 June 2017.

Indexed as

PhytotherapyRandomized Controlled Trials as TopicBacopaCognitionCognitive DysfunctionDietary SupplementsDouble-Blind MethodElectroencephalographyGinkgo bilobaGinkgo ExtractHumansOutcome Assessment, Health CarePanaxPlant ExtractsThioctic AcidGinkgo biloba extractGinkgo ExtractPlant ExtractsThioctic AcidCognition Support Formula®CogState®EEGHerbal medicineRandomised controlled trialSubjective cognitive impairment (SCI)

Identifiers

PMID31182153
PMCPMC6558749
OpenAlexW2951756798

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.