Mild Cognitive Impairment (MCI) Mental and Behavioural Disorders Mild Cognitive Impairment (MCI)
Conditions
Interventions
MCI subjects (n=60) will be randomised in a 50:50 masked fashion to either active supplement or placebo. Control subjects with no cognitive impairment (n=60) will be randomised in a 50:50 masked fashi
Sponsors
Waterford Institute of Technology Macular Pigment Research Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: MCI participants: 1. Males and females aged 65 years and over 2. Self or family member reported memory loss 3. Functionally independent in activities of daily living (as per BADLS) 4. Fulfils criteria for minimal cognitive impairment (as per RBANS) 5. Consensus panel agreement on the diagnosis of MCI (where applicable) Non-MCI participants: 1. Males and females aged 65 years and over 2. Functionally independent in activities of daily living (as per BADLS) 3. Confirms absence of any cognitive impairment (as per RBANS)
Exclusion criteria
Exclusion criteria: 1. Active depression (under active review) 2. Established diagnosis of early dementia (on cognitive enhancement therapy) 3. Current psychiatric illness (under active review of psychotropic medications) 4. Stroke disease (clinical stroke or stroke on CT) 5. Rapidly progressive or fluctuating symptoms of memory loss 6. Already consuming carotenoid supplements (e.g. Macushield) or fish oil supplements (e.g. Souvenaid) 7. Already on cholinesterase inhibitors or NMDA receptor antagonists 8. Fish allergy 9. Acute angle glaucoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive function will be measured at baseline, 12 and 24 months using the following methods: 1. Montreal Cognitive Assessment (MoCA) 2. Alzheimer’s Questionnaire (AQ) 3. Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) 4. Bristol Activities of Daily Living Scale (BADLS) 5. An electroencephalogram or EEG system (BP LiveAmp System, Brain Vision UK) 6. Tests of attention, memory, executive function and decision making from the Cambridge Neuropsychological Test Automated Battery (CANTAB, Cambridge Cognition, UK) As of 18/02/2016, the following outcome measure will no longer be measured: Phonemic fluency (the FAS test) which involves naming as many words as possible within a 1 minute time limit, starting with each letter of the alphabet | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Macular pigment will be measured by dual-wavelength autoflourescence using the Spectralis HRA + OCT Multicolour at baseline, 12 and 24 months 2. Visual function will be assessed using both best-corrected visual acuity and letter contrast sensitivity at 5 spatial frequencies at baseline, 12 and 24 months 3. Serum carotenoid (lutein, zeaxanthin, meso-zeaxanthin) and vitamin E concentrations will be measured from a blood sample using a reverse-phase High Performance Liquid Chromatography (HPLC) method at baseline, 12 and 24 months 4. Serum lipid concentrations will be measured from a blood sample using mass spectrometry at baseline, 12 and 24 months 5. Red cell DHA and EPA will be measured from a blood sample using gas chromatography at baseline, 12 and 24 months 6. Development of Alzheimer's disease will be determined based on consensus panel assessment at baseline, 12 and 24 months, and using the 4 Mountains test at baseline Original secondary outcome measure point 1: 1. Macular pigment will be measured by dual-wavelength autoflourescence using the Spectralis HRA + OCT Multicolour and using customised heterochromatic flicker photometry (cHFP) at baseline, 12 and 24 months | — |
Countries
Ireland
Contacts
Public ContactRebecca Power
Outcome results
None listed