NCT04972643

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 23, 2012

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2018

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

5.6 years

First QC Date

February 8, 2018

Last Update Submit

July 22, 2021

Conditions

Alzheimer DiseaseDementia Disorder

Keywords

Dementia Alzheimer

Outcome Measures

Primary Outcomes (56)

  • Aspartate Aminotransferase (AST)

    Day 0

  • Aspartate Aminotransferase (AST)

    Day 24 month

  • Alanine Aminotransferase (ALT)

    Day 0

  • Alanine Aminotransferase (ALT)

    Day 24 month

  • Albumin level

    Day 0

  • Albumin level

    Day 24 month

  • Fasting blood glucose

    Day 0

  • Fasting blood glucose

    Day 24 month

  • Blood Urea Nitrogen (BUN)

    Day 0

  • Blood Urea Nitrogen (BUN)

    Day 24 month

  • Creatinine level

    Day 0

  • Creatinine level

    Day 24 month

  • Sodium (Na)

    Day 0

  • Sodium (Na)

    Day 24 month

  • Potassium (K)

    Day 0

  • Potassium (K)

    Day 24 month

  • Calcium (Ca)

    Day 0

  • Calcium (Ca)

    Day 24 month

  • Magnesium (Mg)

    Day 0

  • Magnesium (Mg)

    Day 24 month

  • Triiodothyronine (T3)

    Day 0

  • Triiodothyronine (T3)

    Day 24 month

  • Free tetraiodothyronine (free T4)

    Day 0

  • Free tetraiodothyronine (free T4)

    Day 24 month

  • Thyroxin stimulating hormone (TSH)

    Day 0

  • Thyroxin stimulating hormone (TSH)

    Day 24 month

  • Triglycerides

    Day 0

  • Triglycerides

    Day 24 month

  • Total cholesterol

    Day 0

  • Total cholesterol

    Day 24 month

  • High density lipoprotein cholesterol (HDL)

    Day 0

  • High density lipoprotein cholesterol (HDL)

    Day 24 month

  • Low density lipoprotein cholesterol (LDL)

    Day 0

  • Low density lipoprotein cholesterol (LDL)

    Day 24 month

  • Vitamine B12 level

    Day 0

  • Vitamine B12 level

    Day 24 month

  • Folic acid

    Day 0

  • Folic acid

    Day 24 month

  • Rapid plasma reagin for Syphilis test (RPR)

    Day 0

  • Rapid plasma reagin for Syphilis test (RPR)

    Day 24 month

  • Mini Mental Status Evaluation (MMSE) total score

    Minimu:0, Maximum: 30, Higher scores mean a better outcome.

    Day 0

  • Mini Mental Status Evaluation (MMSE) total score

    Minimu:0, Maximum: 30, Higher scores mean a better outcome.

    Day 24 month

  • Clinical Dementia Rating Scale (CDR) total score

    Minimu:0, Maximum: 3, Higher scores mean a worse outcome.

    Day 0

  • Clinical Dementia Rating Scale (CDR) total score

    Minimu:0, Maximum: 3, Higher scores mean a worse outcome.

    Day 24 month

  • Hachinski ischemic score total score

    Minimu:0, Maximum: 18, Higher scores mean a worse vascular outcome.

    Day 0

  • Hachinski ischemic score total score

    Minimu:0, Maximum: 18, Higher scores mean a worse vascular outcome.

    Day 24 month

  • Alzheimer's Disease Assessment Scale-cognitive section (ADAS-Cog) total score

    Minimu:0, Maximum: 70, Higher scores mean a worse outcome.

    Day 0

  • Alzheimer's Disease Assessment Scale-cognitive section (ADAS-Cog) total score

    Minimu:0, Maximum: 70, Higher scores mean a worse outcome.

    Day 24 month

  • Alzheimer's Disease Assessment Scale-activities of daily living section (ADCS-ADL) total score

    Minimu:0, Maximum: 54, Higher scores mean a better outcome.

    Day 0

  • Alzheimer's Disease Assessment Scale-activities of daily living section (ADCS-ADL) total score

    Minimu:0, Maximum: 54, Higher scores mean a better outcome.

    Day 24 month

  • Geriatric Depression Scale (GDS) total score

    Minimu:0, Maximum: 15, Higher scores mean a worse outcome.

    Day 0

  • Geriatric Depression Scale (GDS) total score

    Minimu:0, Maximum: 15, Higher scores mean a worse outcome.

    Day 24 month

  • Quality of Life- Alzheimer Dementia (QOL-AD) total score

    Minimu:13, Maximum: 52, Higher scores mean a better outcome.

    Day 0

  • Quality of Life- Alzheimer Dementia (QOL-AD) total score

    Minimu:13, Maximum: 52, Higher scores mean a better outcome.

    Day 24 month

  • MRI examination 1

    Total brain volume: MRI examination will be performed on the 1.5 Telsla machine (GE, USA)

    Day 0

  • MRI examination 2

    Total brain volume: MRI examination will be performed on the 1.5 Telsla machine (GE, USA)

    Day 24 months

Study Arms (4)

EPA and DHA intervention

EXPERIMENTAL

EPA 1000mg and DHA 1000mg capsule twice a day, the total exposure to the intervention for each subject is 24 months.

Dietary Supplement: EPADietary Supplement: DHA

EPA intervention

EXPERIMENTAL

EPA 2000mg capsule twice a day, the total exposure to the intervention for each subject is 24 months.

Dietary Supplement: EPA

DHA intervention

EXPERIMENTAL

DHA 2000mg capsule twice a day, the total exposure to the intervention for each subject is 24 months.

Dietary Supplement: DHA

Placebo

PLACEBO COMPARATOR

Placebo 2000mg capsule twice a day, the total exposure to the intervention for each subject is 24 months.

Dietary Supplement: Placebo

Interventions

EPADIETARY_SUPPLEMENT

EPA 2000mg Soft capsules

EPA and DHA interventionEPA intervention
DHADIETARY_SUPPLEMENT

DHA 2000mg Soft capsules

DHA interventionEPA and DHA intervention
PlaceboDIETARY_SUPPLEMENT

Placebo Soft capsules

Placebo

Eligibility Criteria

Age65 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients may be included in the study if they meet the following criteria:
  • Males and females over 65 years of age.
  • Diagnosis of Alzheimer's Dementia disorder.
  • Each individual must have a level of understanding sufficient to perform all tests and examinations required.
  • Individuals must be willing to accept all laboratory examinations and MRI examination.
  • Individuals must be willing to provide a small sample of blood for evaluation.
  • Individuals must be willing to participate in a short 30-60 minute clinical interview.

You may not qualify if:

  • Patients may be excluded from the study for any of the following reasons:
  • Serious unstable illness such that death is anticipated within 1 year or intensive care unit hospitalization for the condition is anticipated within 6 months.
  • Diagnosis of Vascular Dementia disorder.
  • Uncorrected hypothyroidism or hyperthyroidism
  • Participants will be excluded if they had evidence of epilepsy; focal brain lesion; head injury with loss of consciousness or confusion after the injury; DSMIV-TR (text revision) criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, or alcohol or substance abuse; or potential bleeding tendency.
  • History of allergy to fish or omega-3 polyunsaturated fatty acids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, No.450,Sec.1,Dongda Rd.,Xitun Dist., 40764, Taiwan

Location

Related Publications (6)

  • Ferri CP, Prince M, Brayne C, Brodaty H, Fratiglioni L, Ganguli M, Hall K, Hasegawa K, Hendrie H, Huang Y, Jorm A, Mathers C, Menezes PR, Rimmer E, Scazufca M; Alzheimer's Disease International. Global prevalence of dementia: a Delphi consensus study. Lancet. 2005 Dec 17;366(9503):2112-7. doi: 10.1016/S0140-6736(05)67889-0.

    PMID: 16360788BACKGROUND

  • World Alzheimer Report 2010. Alzheimer's Disease International, 2010.

    BACKGROUND

  • Brookmeyer R, Johnson E, Ziegler-Graham K, Arrighi HM. Forecasting the global burden of Alzheimer's disease. Alzheimers Dement. 2007 Jul;3(3):186-91. doi: 10.1016/j.jalz.2007.04.381.

    PMID: 19595937BACKGROUND

  • Daviglus ML, Bell CC, Berrettini W, Bowen PE, Connolly ES Jr, Cox NJ, Dunbar-Jacob JM, Granieri EC, Hunt G, McGarry K, Patel D, Potosky AL, Sanders-Bush E, Silberberg D, Trevisan M. National Institutes of Health State-of-the-Science Conference statement: preventing alzheimer disease and cognitive decline. Ann Intern Med. 2010 Aug 3;153(3):176-81. doi: 10.7326/0003-4819-153-3-201008030-00260. Epub 2010 Jun 14.

    PMID: 20547888BACKGROUND

  • Barnes DE, Yaffe K. The projected effect of risk factor reduction on Alzheimer's disease prevalence. Lancet Neurol. 2011 Sep;10(9):819-28. doi: 10.1016/S1474-4422(11)70072-2. Epub 2011 Jul 19.

    PMID: 21775213BACKGROUND

  • Wang XD, Kashii S, Zhao L, Tonchev AB, Katsuki H, Akaike A, Honda Y, Yamashita J, Yamashima T. Vitamin B6 protects primate retinal neurons from ischemic injury. Brain Res. 2002 Jun 14;940(1-2):36-43. doi: 10.1016/s0006-8993(02)02587-8.

    PMID: 12020872BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Tsuo-Hung Lan, MD, PhD.

    National Yang Ming Chiao Tung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Psychiatry, Taichung Veterans General Hospital

Study Record Dates

First Submitted

February 8, 2018

First Posted

July 22, 2021

Study Start

September 23, 2012

Primary Completion

May 12, 2018

Study Completion

September 23, 2018

Last Updated

July 26, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)