Ignite Creation Date:
2024-05-06 @ 4:24 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04972643
Status:
COMPLETED
Last Update Posted:
2021-07-26
First Post:
2018-02-08
Brief Title:
The Protective Effect of Omega-3 Fatty Acid on Cognitive Function Among Patients With Mild Dementia
Sponsor:
Taichung Veterans General Hospital
Organization:
Taichung Veterans General Hospital
Study Overview
Official Title:
Department of Psychiatry Taichung Veterans General Hospital
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Dementia is a progressive devastating and fatal neurodegenerative disorder Alzheimers 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 05-1 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
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 05-1 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
Detailed Description:
Background Dementia is a progressive devastating and fatal neurodegenerative disorder Cummings 2004 As of 2010 there are an estimated 356 million people with dementia worldwide By 2050 it is projected that this figure will have increased to over 115 million 1 2 Therefore dementia is not only an important medical disease but also a public health issue to demand immediate attention A conservative estimate of economic burden from dementia based on Alzheimers Societys Dementia United Kindom UK report published in February 2007 reaches 20 billion by the year 2010 which suggests an average cost of 25472 per person annually It indicated a heavy social financial expense for the whole world in general Alzheimers disease AD is the most common cause of dementia accounting for 60-80 of patients with dementia Given that it is still lacking in effective treatments for AD there has been growing interest in early detection and prevention for this disastrous illness Delaying AD onset by 1 year could potentially lower its incidence by more than 9 million cases over the next 40 years 3
Dementia could be resulted from numerous risk factors and medical conditions including vascular risk factors eg hypertension diabetes and obesity psychosocial factors eg depression and health behaviors eg physical inactivity and smoking 4 5 Indeed reflecting its heterogeneity several hypotheses have been proposed for etiology of dementia including genetic susceptibility vascular changes inflammatory process oxidative stress and recently n-3 polyunsaturated fatty acids n-3 PUFAs Fratiglioni et al 2008Samieri et al 2008Cole and Frautschy 2010Mucke and Pitas 2004Gomez-Pinilla 2008 PUFAs are classified into mainly n-3 or omega-3 and n-6 or omega-6 groups Docosahexaenoic acid DHA and eicosapentaenoic acid EPA the major bioactive components of n-3 PUFAs are associated with neuronal membrane stability and fluidity neurogenesis neuroplasticity neurotransmission and anti-inflammation which might connect to the etiology of several neuropsychiatric diseases including depression and dementia Horrobin and Bennett 1999Su et al 2000Chalon 2006Lukiw and Bazan 2006Su 2009bLin et al 2010a On the other hand arachidonic acid AA the major components of n-6 PUFAs is a precursor of eicosanoids and is important to modulate proinflammatory effects which might also link to the pathogenesis of neuroinflammatory and neurodegenerative diseases like dementia Sanchez-Mejia and Mucke 2010Lukiw and Bazan 2010 Consistent with the theoretical relevance evidences to link PUFAs to dementia have been reported extensively from more epidemiological studies For example it has been observed that regions with a high consumption of fish which are good sources of n-3 PUFAs appear to have a lower prevalence of dementia Barberger-Gateau et al 2002Barberger-Gateau et al 2007Huang et al 2005Morris et al 2003Kalmijn et al 1997 and Mild cognitive Impairment MCI Roberts et al 2010 Although clinical studies until now have failed to demonstrate beneficial effects of n-3 PUFA supplementation in patients with moderate or severe AD Freund-Levi et al 2006aQuinn et al 2010a it may benefit in patients with mild AD or MCI and those without apolipoprotein EAPOE ε4 allele Freund-Levi et al 2006bChiu et al 2008Quinn et al 2010b In addition the two main n-3 PUFAs have different biological effects DHA is the main n-3 PUFAs in the brain and is important in neuroplasticity and neuroprotection EPA on the other hand is very little in the brain but is important in modulate inflammation and immune function Lin et al 2010bSu 2009a To our knowledge it has never been studied to look at the different effects of DHA EPA and their combination on different associated symptoms of AD To provide more evidence for the association between n-3 PUFAs and associated symptoms of AD including cognitive function depression and physical activity in AD we propose to conduct this double-blind placebo-controlled 24-month research In addition neuroprotective effects of vitamin B preliminary findings in recent studies have shown cognitive-protection effects of it among patients with MCI Moreover deficiency of vitamin B is known to cause nervousness depression and peripheral and central neuropathy The importance of vitamin B in developmental processes of the brain is supported by the findings that vitamin B deficiency at certain stages of brain development interferes with brain cell proliferation migration and maturation Vitamin B affords survival-promoting activities on cultured brain neurons 6 This is probably the first study to evaluate the effects of vitamin B on cognitive protection among Asian patients with AD Based on the review of the possible benefits from n-3 PUFAs supplement on cognitive function preservation after balancing for its slightest side effects we here propose a randomized clinical trial study design to test whether Hypothesis Omega-3 PUFAs is protective against cognitive decline among people with mild AD
Primary Aim To examine whether consumption of n-3 PUFAs protects against cognitive decline in patients with mild AD
Secondary Aims
1 To examine the different effects of DHA EPA and their combination on different symptoms of AD
2 To examine whether consumption of n-3 PUFAs improves cognitive function in patients with mild AD
3 To examine whether consumption of n-3 PUFAs improves depressive symptoms in patients with mild AD
4 To examine whether consumption of n-3 PUFAs improves physical activity level in patients with mild AD
Significance of Study
1 To provide a simple way through dietary supplement of n-3 PUFAs to prevent cognitive decline and improve depressive symptoms and physical activity in patients with mild AD
2 No placebo-controlled studies regarding n-3 PUFAs in cognitive prevention have been conducted among Asian people
Dementia could be resulted from numerous risk factors and medical conditions including vascular risk factors eg hypertension diabetes and obesity psychosocial factors eg depression and health behaviors eg physical inactivity and smoking 4 5 Indeed reflecting its heterogeneity several hypotheses have been proposed for etiology of dementia including genetic susceptibility vascular changes inflammatory process oxidative stress and recently n-3 polyunsaturated fatty acids n-3 PUFAs Fratiglioni et al 2008Samieri et al 2008Cole and Frautschy 2010Mucke and Pitas 2004Gomez-Pinilla 2008 PUFAs are classified into mainly n-3 or omega-3 and n-6 or omega-6 groups Docosahexaenoic acid DHA and eicosapentaenoic acid EPA the major bioactive components of n-3 PUFAs are associated with neuronal membrane stability and fluidity neurogenesis neuroplasticity neurotransmission and anti-inflammation which might connect to the etiology of several neuropsychiatric diseases including depression and dementia Horrobin and Bennett 1999Su et al 2000Chalon 2006Lukiw and Bazan 2006Su 2009bLin et al 2010a On the other hand arachidonic acid AA the major components of n-6 PUFAs is a precursor of eicosanoids and is important to modulate proinflammatory effects which might also link to the pathogenesis of neuroinflammatory and neurodegenerative diseases like dementia Sanchez-Mejia and Mucke 2010Lukiw and Bazan 2010 Consistent with the theoretical relevance evidences to link PUFAs to dementia have been reported extensively from more epidemiological studies For example it has been observed that regions with a high consumption of fish which are good sources of n-3 PUFAs appear to have a lower prevalence of dementia Barberger-Gateau et al 2002Barberger-Gateau et al 2007Huang et al 2005Morris et al 2003Kalmijn et al 1997 and Mild cognitive Impairment MCI Roberts et al 2010 Although clinical studies until now have failed to demonstrate beneficial effects of n-3 PUFA supplementation in patients with moderate or severe AD Freund-Levi et al 2006aQuinn et al 2010a it may benefit in patients with mild AD or MCI and those without apolipoprotein EAPOE ε4 allele Freund-Levi et al 2006bChiu et al 2008Quinn et al 2010b In addition the two main n-3 PUFAs have different biological effects DHA is the main n-3 PUFAs in the brain and is important in neuroplasticity and neuroprotection EPA on the other hand is very little in the brain but is important in modulate inflammation and immune function Lin et al 2010bSu 2009a To our knowledge it has never been studied to look at the different effects of DHA EPA and their combination on different associated symptoms of AD To provide more evidence for the association between n-3 PUFAs and associated symptoms of AD including cognitive function depression and physical activity in AD we propose to conduct this double-blind placebo-controlled 24-month research In addition neuroprotective effects of vitamin B preliminary findings in recent studies have shown cognitive-protection effects of it among patients with MCI Moreover deficiency of vitamin B is known to cause nervousness depression and peripheral and central neuropathy The importance of vitamin B in developmental processes of the brain is supported by the findings that vitamin B deficiency at certain stages of brain development interferes with brain cell proliferation migration and maturation Vitamin B affords survival-promoting activities on cultured brain neurons 6 This is probably the first study to evaluate the effects of vitamin B on cognitive protection among Asian patients with AD Based on the review of the possible benefits from n-3 PUFAs supplement on cognitive function preservation after balancing for its slightest side effects we here propose a randomized clinical trial study design to test whether Hypothesis Omega-3 PUFAs is protective against cognitive decline among people with mild AD
Primary Aim To examine whether consumption of n-3 PUFAs protects against cognitive decline in patients with mild AD
Secondary Aims
1 To examine the different effects of DHA EPA and their combination on different symptoms of AD
2 To examine whether consumption of n-3 PUFAs improves cognitive function in patients with mild AD
3 To examine whether consumption of n-3 PUFAs improves depressive symptoms in patients with mild AD
4 To examine whether consumption of n-3 PUFAs improves physical activity level in patients with mild AD
Significance of Study
1 To provide a simple way through dietary supplement of n-3 PUFAs to prevent cognitive decline and improve depressive symptoms and physical activity in patients with mild AD
2 No placebo-controlled studies regarding n-3 PUFAs in cognitive prevention have been conducted among Asian people
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None