Triglyceride-rich Lipoprotein and Development of Dementia

NCT02814422 | Unknown DMC

• 1 other identifier: 201407002RIND
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Because of the rapid aging of the global population, dementia has become a serious problem, and Alzheimer's 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 4,492 patients with atherosclerotic vascular diseases (AVD). In addition, the investigators have also registered 8,209 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.

Conditions

Dementia

Keywords

Triglyceride-rich lipoprotein; dementia; Alzheimer's disease; mild cognition impairment; amyloid-beta

Outcome Measures

Primary Outcomes (1)

• Composite cardiovascular outcome

  The composite cardiovascular (CV) outcome will be any CV events (coronary, cerebral, or peripheral vascular diseases)

  up to 5 years

Secondary Outcomes (1)

• With at least 1 cardiovascular risk factor.

  up to 5 years

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In this project, three hundred male or female patients with stable symptomatic atherosclerotic disease over 20 years of age will be enrolled from our previous registry program. Peripheral atherosclerosis with symptoms of ischemia and confirmed by ankle-brachial index, Doppler ultrasound, or angiography will also be included (group A). The other 1000 patients will be enrolled with no evidence of atherosclerotic vascular diseases, but with at least 1 CV risk factor \[DM, dyslipidemia (TC \>200 mg/dL; LDL-C \> 130 mg/dL ; TG \> 200 mg/dL; male HDL-C \< 40 mg/dL ; female HDL-C \< 50 mg/dL) or under lipid lowering therapy, hypertension, smoking, old (M\>45, F\>55 years), family history of premature CAD (M\<55, F\<65 years), obesity (waist: M\>90, F\>80 cm)\] (group B).

You may qualify if:

• age older than 20 years old
• willing to sign ICF
• report oneself disease
• have Taiwanese ID
• atherosclerotic vascular diseases, but with at least 1 CV risk factor \[DM, dyslipidemia or under lipid lowering therapy, hypertension, smoking, old (M\>45, F\>55 years), family history of premature CAD, obesity

You may not qualify if:

• not willing to sign ICF

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

NTUH

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Chau C Wu, M.D., Ph.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chau C Wu, M.D., Ph.D.

CONTACT

886-2-23123456; chauchungwu@ntu.edu.tw

Wan T Ke

CONTACT

886-2-23123456; t87134@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: June 27, 2016
• Study Start: July 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: January 18, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)