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Clinical Trials/ISRCTN10431469
ISRCTN10431469
Completed
未知

Cognitive impAiRmEnt Study: Supplementation with the macular carotenoids, vitamin E and fish oil

Waterford Institute of Technology Macular Pigment Research Group0 sites120 target enrollmentDecember 21, 2015
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ConditionsMild Cognitive Impairment (MCI)Mental and Behavioural Disorders

Overview

Phase
未知
Intervention
Not specified
Conditions
Mild Cognitive Impairment (MCI)
Sponsor
Waterford Institute of Technology Macular Pigment Research Group
Enrollment
120
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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)

Registry
who.int
Start Date
December 21, 2015
End Date
December 30, 2019
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Waterford Institute of Technology Macular Pigment Research Group

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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