DOI: 10.26183/hxwn-pv57
title: SCI CogSupport: Effectiveness of a Herbal and Nutritional Supplement on Cognitive Function in Older Adults with Subjective Cognitive Impairment

description: Background: Due to Australia’s ageing population, there has been an increase in older adults with subjective cognitive impairment (SCI); a self-reported decline in cognitive function associated with an increased risk of mild cognitive impairment (MCI) and dementia.  There is no current recommended treatment for SCI, therefore, the effectiveness of a supplement approved by the Therapeutic Goods Association (TGA) that has the potential to enhance cognitive function in an at-risk cohort should be tested.   

Aims and Expected Outcomes: The primary aim of the proposed research is to determine the efficacy of 6 months 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 to 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 and fatigue.  It is expected that improvements across the study timepoints in the co-primary outcomes in the active treatment group (compared to placebo) will be evident.   

Materials and Methods: Seventy-four 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 (CogState®), mood (DASS-42, SHAI), and fatigue (FACIT-F) tests at baseline (0 months), midpoint (3 months), and endpoint (6 months), that will be evaluated between timepoints (baseline vs. midpoint, midpoint vs. endpoint, and baseline vs. endpoint).  Adverse effects will be documented over the 6-month trial period.   

Summary: 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. 

This dataset contains the following four Excel spreadsheets: 

Deidentified_Master Data Spreadsheet 300823: This Excel spreadsheet contains the dataset for analysis. 

Deidentified_Medication Count 180125: This Excel spreadsheet contains the compliance information. 

Deidentified_PRISMA, Withdrawals, AEs 310723: This Excel spreadsheet contains information regarding the PRISMA details, withdrawals, severe adverse event tallies, adverse event tallies, and the information used to determine and define adverse events 

Identifiable_Participant Enrolment IDs 110723: This Excel spreadsheet contains identifiable information regarding participant ID allocation, as well as sex breakdown. 

This data cannot be shared publicly due to ethics approval conditions. To discuss this data, please contact the NICM Health Research Institute nicm@westernsydney.edu.au.