None listed
Conditions
Brief summary
This study will investigate a novel treatment for Mild Cognitive Impairment in older adults. We will explore if the dietary supplement creatine (Cr) is able to enhance the effects of computer-based cognitive training. The study will randomly allocate 50 eligible participants into one of two groups: cognitive training and Cr, or cognitive training and placebo (Maltodextrin). All participants will take part in a 12-week cognitive training program involving twice- weekly sessions, while Cr/placebo will be taken at home on a daily basis. Cognitive training incorporates games and tasks that target various cognitive domains such as memory and attention, allowing for graded and progressive increases in difficulty. Creatine (Cr) has been successfully evaluated across a range of neurological, neuromuscular and medical conditions. It is a naturally occurring compound that is acquired from high protein foods such as meat, and can also be taken as a dietary supplement. Cr is thought to aid effective brain functioning through its impact on a particular neurotransmitter, glutamate. Both cognitive training and Cr have shown positive effects on cognitive functioning in prior research, however to-date they have never been combined as a therapeutic bundle. In this trial, participants and all clinicians involved will not know whether the participant is taking Cr or placebo, in order to keep the results objective and unbiased. We hypothesize that combining cognitive training and Cr will be more effective at improving cognitive functioning and other relevant outcomes than cognitive training and placebo. We will assess for improvements via standardized neuropsychological tests, self-report measures and non-invasive at-home sleep measurement which will be conducted before and after the intervention.
Interventions
The intervention comprises daily oral creatine supplementation as an adjunctive treatment to a 12-week, twice-weekly cognitive training program. In this trial, all participants will complete the same cognitive training program; however the experimental condition refers to whether the adjunctive dietary supplement is active (i.e. creatine) or inactive (i.e. placebo). This will be randomly allocated. In terms of the dietary supplements, participants will self-administer one daily oral dose, administered in 5g sachets. Participants will be instructed to dissolve the supplement in warm water and take one-hour before or after meals in order to maximise absorption. In both the active and inactive arms, an initial dose of 10g (5g twice daily) will be administered for 3 days to assess for tolerance. If the supplements are well tolerated, then a loading dose of 20g (10g twice daily) will be administered for the following 4 days. Subsequently, a maintenance dose of 10g (5g twice daily) will continue for a further 11 weeks, i.e. over the duration of the cognitive training period. Participants will be given written instructions for administration of all supplements. Participants will be asked to return any unused medication for adherence checks and safety on a fortnightly basis, in line with the dispensing schedule. At each dispensation, the trial clinician will do a compliance check as well as check for side effects or any adverse events the participants might have experienced. Participants will also receive a medication tracking calendar to aid compliance and recording of any side effects. The cognitive training program used in this trial is the computer-based Captains Log MindPower Builder software package, which targets multiple cognitive domains using an array of both auditory and visual exercises requiring responses via keyboard and mouse clicks. All participants will complete the same program of tasks; however graded difficulty is automatically adapted for each individual by the software program, with difficulty increasing as the participant improves their performance on each task. Each training session will last for 1 hour. The training will take place in a purpose-built cognitive training computer laboratory at the Brain and Mind Centre, Camperdown, Sydney. Each participant will work at their own computer and at their own pace; however multiple participants may attend the same training session simultaneously (based on availability). The training sessions will be run by trained facilitators comprising both Clinical Neuropsychologists, postdoctoral researchers and PhD students all of whom have received specialised training in these techniques and whom are experienced in facilitating cognitive training in over 400 older adults.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Aged 60 years or older; 2. Ability to read, write and communicate in English; 3. Ability to attend two sessions per week for 12 weeks at the training centre; 4. Sufficient physical abilities (motor, eyesight, hearing) to use a computer; 5. Cognitive impairment in memory or other cognitive domain (i.e., 1.5 SD below their expected level of performance based on normative data), measured within the last 6 months; 6. MCI diagnosis: this will be determined by consensus of three independent clinician raters and will follow Winblad’s criteria.
Exclusion criteria
1. Bayler-ADL > 3.0 2. MMSE < 24 3. Geriatric Depression Scale > 7 4. Intellectual disability 5. Current diagnosis of: - Dementia, - Major Depressive Episode (within the last 6 months), - Neurological illness (e.g. epilepsy, Parkinson’s Disease), - Non-affective psychiatric illness (e.g. schizophrenia), - Loss of consciousness >30-minutes in the past 12 months, - Stroke, - Diabetes and/or insulin resistance, - Renal impairment (defined by serum creatinine-estimated Glomerular Filtration Rate <60mL/min) - Gastrointestinal disease or food allergies (e.g. coeliac disease, corn starch allergy and/or irritable bowel syndrome). 6. Electroconvulsive Therapy 7. Current/past alcohol or substance dependence (other than nicotine) 8. Use of cholinesterase inhibitors or other cognitive enhancing drugs 9. Current treatment with diuretics, NSAIDS, Probenecid, Cimetidine, aminoglycoside antibiotics and/or lansopraxolem 10. Clinical history of hepatic disease or chronic or acute renal impairment or failure 11. Presence of abnormal Liver Function Test results: abnormality defined on ANY of the following as per local laboratory thresholds: albumin, alanine transaminase ALT, aspartate transaminase AST, alkaline phosphatase ALP, bilirubin, gamma glutamyl transpeptidase GGT).