None listed
Conditions
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.
Interventions
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
Sponsors
Mrs Adele Cave
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to 85 Years
Healthy volunteers
No
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.
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. 13. A MoCA score of <23 and/or impairments on gold standard neuropsychological measures such as the RAVLT. Impairments will be defined as 2 SDs below the normative mean and/or 2 SDs below expected levels of premorbid function as measured by the TOPF. 14. Study neuropsychologist discretion regarding cognitive status based on neuropsychometric performance (RAVLT, MoCA etc). 15. Clinically significant abnormalities as per laboratory blood test results as determined by the study clinician. 16. Study clinician discretion regarding medical status, appropriateness of participation or concern about intervention adherence. 17. Commencement of the trial supplement must not occur within two weeks of receiving an immunisation so that it is possible to dissociate the effects of the supplement and the effect of the immunisations.
Outcome results
None listed