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The Protective Effect of Omega-3 Fatty Acid on Cognitive Function Among Patients With Mild Dementia

NCT04972643 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2021-07-26

No results posted yet for this study

Summary

Background： Dementia is a progressive, devastating, and fatal neurodegenerative disorder. Alzheimer's disease (AD) is the most common cause of dementia, accounting for more than 50% of patients with dementia. Docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), the major bioactive components of n-3 polyunsaturated fatty acids (n-3 PUFAs) , might connect to the etiology of several neuropsychiatric diseases. To our knowledge, it has never been studied to look at the different effects of DHA, EPA and their combination on associated symptoms of AD.

Objectives To examine the effects of DHA, EPA and their combination on associated symptoms of AD, including cognitive function, depressive symptoms, and functional ability.

Method This is a randomized, double-blind, placebo-controlled, 24-month follow-up study, enrolling 200-400 patients with mild AD (Mini-Mental Status Examination (MMSE) 19-26 or Clinical Dementia Rating (CDR) 0.5-1). Cognitive ability is assessed by the Alzheimer Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) and the MMSE. Mood status is assessed by Geriatric Depression Scale (GDS). Functional ability is assessed by the Alzheimer Disease Cooperative Study activities of daily living (ADCS-ADL) and global function by the CDR, quality of life scale (QOL-AD). Brain function is assessed by resting state brain magnetic resonance imaging (MRI).

Conditions

  • Alzheimer Disease
  • Dementia Disorder

Interventions

DIETARY_SUPPLEMENT

EPA

EPA 2000mg Soft capsules

DIETARY_SUPPLEMENT

DHA

DHA 2000mg Soft capsules

DIETARY_SUPPLEMENT

Placebo

Placebo Soft capsules

Sponsors & Collaborators

  • Taichung Veterans General Hospital

    lead OTHER

Principal Investigators

  • Tsuo-Hung Lan, MD, PhD. · National Yang Ming Chiao Tung University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
105 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-23
Primary Completion
2018-05-12
Completion
2018-09-23

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04972643 on ClinicalTrials.gov