Viewing Study NCT02814422



Ignite Creation Date: 2024-05-06 @ 8:46 AM
Last Modification Date: 2024-10-26 @ 12:04 PM
Study NCT ID: NCT02814422
Status: UNKNOWN
Last Update Posted: 2017-01-18
First Post: 2016-06-23

Brief Title: Triglyceride-rich Lipoprotein and Development of Dementia
Sponsor: National Taiwan University Hospital
Organization: National Taiwan University Hospital

Study Overview

Official Title: Triglyceride-rich Lipoprotein and the Development of Dementia
Status: UNKNOWN
Status Verified Date: 2017-01
Last Known Status: RECRUITING
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: Because of the rapid aging of the global population dementia has become a serious problem and Alzheimers disease AD is the most common cause of dementia AD is pathologically characterized by substantial neuronal loss and chronic inflammation that is associated with cerebrovascular and parenchymal accumulation of proteinaceous deposits enriched in amyloid-beta Aβ More recent evidence shows it is due to an increased blood-to-brain delivery of circulating Aβ and significant peripheral Aβ metabolism occurs in association with post-prandial triglyceride-rich lipoproteins

In the prodromal stage of AD patients usually suffer mild cognition impairment MCI The annual conversion rate of MCI to AD is around 10 and within 3 years around 30-50 of these develop dementia Brain atrophy is an irreversible brain disease that causes problems with cognitive and memory functions in many diseases such as MCI and AD etc In order to allow preventive intervention for AD MCI must be diagnosed as early as possible using biomarker assays or simple imaging modality From 2009-2013 the investigators have registered 4492 patients with atherosclerotic vascular diseases AVD In addition the investigators have also registered 8209 cases with no evidence of AVD but with at least 1 cardiovascular risk factor In this 5-year project 300 male or female patients with stable symptomatic AVD over 20 years of age and the other 600 patients with no evidence of AVD but with at least 1 CV risk factor will be enrolled from our previous registry program The baseline and yearly follow-up study will include clinical examination neurocognitive function evaluation and laboratory tests TC HDL-C LDL-C TG hs-CRP and Aβ-40 Aβ-42 tau protein and other biological signatures adiponectin MMP-3 MMP-9 IL-6 Fibrinogen Lp-PLA2 8-Isoprostane hFABP sVCAM-1 sICAM-1 CA-125 MCP-1 TNF-α cTnI NT-proBNP CNP NGAL

The purposes of this 5-year project are 1 to clarify the association of triglyceride-rich lipoprotein and the development of dementia 2 to validate the diagnostic power and prognostic implication of ultra-low-concentration biomarkers Aβ-40 Aβ-42 and tau for dementia
Detailed Description: Because of the rapid aging of the global population dementia has become a serious problem and Alzheimers disease AD is the most common cause of dementia Population studies have shown that dietary fats influence risk and progression of age-related diseases including AD diabetes and cardiovascular disease Consumption of saturated fat trans-fatty acids and cholesterol are positively associated with increased risk These findings support the hypothesis that dietary saturated-fats SFA and cholesterol or dietary induced dyslipidemia are causally associated with AD risk AD is pathologically characterized by substantial neuronal loss and chronic inflammation that is associated with cerebrovascular and parenchymal accumulation of proteinaceous deposits enriched in amyloid-beta Aβ More recent evidence shows it is due to an increased blood-to-brain delivery of circulating Aβ and significant peripheral Aβ metabolism occurs in association with post-prandial triglyceride-rich lipoproteins

In the prodromal stage of AD patients usually suffer mild cognition impairment MCI The annual conversion rate of MCI to AD is around 10 and within 3 years around 30-50 of these develop dementia Brain atrophy is an irreversible brain disease that causes problems with cognitive and memory functions in many diseases such as MCI and AD etc In order to allow preventive intervention for AD MCI must be diagnosed as early as possible using biomarker assays or simple imaging modality From 2009-2013 the investigators have registered 4492 patients with atherosclerotic vascular diseases AVD In addition the investigators have also registered 8209 cases with no evidence of AVD but with at least 1 cardiovascular risk factor In this 5-year project 300 male or female patients with stable symptomatic AVD over 20 years of age and the other 600 patients with no evidence of AVD but with at least 1 CV risk factor will be enrolled from our previous registry program The baseline and yearly follow-up study will include clinical examination neurocognitive function evaluation and laboratory tests TC HDL-C LDL-C TG hs-CRP and Aβ-40 Aβ-42 tau protein and other biological signatures adiponectin MMP-3 MMP-9 IL-6 Fibrinogen Lp-PLA2 8-Isoprostane hFABP sVCAM-1 sICAM-1 CA-125 MCP-1 TNF-α cTnI NT-proBNP CNP NGAL

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None