Changes in brain function among individuals with a mild memory impairment

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment (MCI); Mental and Behavioural Disorders

• Registration Number: ISRCTN10431469
• Lead Sponsor: Waterford Institute of Technology Macular Pigment Research Group

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32466168/ Participants with MCI (added 10/06/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34999335/ Cognitively healthy participants (added 10/01/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-21
• Study Completion: 2019-12-30
• Last Update Posted: 10 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Cognitive function will be measured at baseline, 12 and 24 months using the following methods:<br> 1. Montreal Cognitive Assessment (MoCA)<br> 2. Alzheimer’s Questionnaire (AQ)<br> 3. Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)<br> 4. Bristol Activities of Daily Living Scale (BADLS)<br> 5. An electroencephalogram or EEG system (BP LiveAmp System, Brain Vision UK)<br> 6. Tests of attention, memory, executive function and decision making from the Cambridge Neuropsychological Test Automated Battery (CANTAB, Cambridge Cognition, UK)<br><br> As of 18/02/2016, the following outcome measure will no longer be measured:<br> 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<br>