Does Creatine Enhance the Effects of Cognitive Training in Older Adults with Mild Cognitive Impairment?

Not Applicable

Recruiting

• Conditions: Mild cognitive impairment; Neurological - Neurodegenerative diseases; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12616000501448
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is learning and memory, assessed using the Rey Auditory Verbal<br>Learning Test (RAVLT; see Lezak, 1995). This test was chosen for its sensitivity to improvements following cognitive training and has also been used in our previous clinical trials of cognitive training in Mild Cognitive Impairment. [This will be conducted at baseline and at post-intervention follow-up, which will be completed within four weeks of cessation of training. Alternate forms of this test will be administered at baseline and follow-up (counterbalanced) to ensure minimization of practice effects.]