Research on the Early and Prognosis Diagnosis of Vascular Dementia

NCT03152630 | Recruiting DMC

• 1 other identifier: 201512101RINA
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Around 10% of stroke survivors develop dementia within 3 months after stroke and over 20% more stroke patients have dementia in the subsequent 3 years. Previous studies documented a close relationship between stroke and Alzheimer's disease (AD). There are, however, no reliable biomarkers to detect cognitive dysfunction and dementia among stroke patients or to predict the risks of vascular dementia (VD) and AD among patients with stroke. There is a clear need to identify novel mediators of cognitive dysfunction in stroke patients to provide insights into the pathogenesis, to tailor clinical care based on risks, and to develop new therapeutic strategies. While the expression of messenger RNAs (mRNAs) and microRNAs (miRNAs) account for only \~1% of all transcribed species, up to 90% of the mammalian genome is transcribed as long non-coding RNAs (lncRNAs), a heterogeneous group of non-coding transcripts longer than 200 nucleotides. LncRNAs have been shown to be functional and involved in specific physiological and pathological processes through epigenetic, transcriptional and post-transcriptional mechanisms. While the roles of lncRNAs in human diseases including cancer and neurodegenerative disorders are beginning to emerge, it remains unclear how lncRNA regulation contributes to cognitive dysfunction and dementia in stroke patients. In this proposal, we seek to apply next-generation sequencing technology to investigate circulating lncRNA expression, as well as exosomal RNAs in the subjects with and without cognitive dysfunction or dementia. In addition, we will apply the near-infrared spectroscopy (NIRS) to evaluate cerebral blood flow, metabolism and oxygenation in these subjects. We will test the hypothesis that circulating lncRNA/exosomal RNA signature and NIRS imagaing can reflect the cognitive states in stroke patients. The accuracy, sensitivity and specificity of the lncRNA-exosomal RNA-NIRS-based cognitive dysfunction scoring system will then be tested in an independent, large validation cohort. Next, we propose to test the hypothesis that circulating lncRNAs/exosomal RNA and NIRS imaging can be novel prognostic biomarkers to predict cognitive dysfunction and dementia in stroke patients. These studies will also establish a set of novel, lncRNA-based diagnostic and prognostic biomarker in stroke patients to improve clinical preventive and therapeutic care.

Conditions

Dementia

Keywords

lncRNAs; Alzheimer's disease; vascular dementia

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
• 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 600 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; Dementia, Vascular

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

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; ntuh33668810@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: May 11, 2017
• First Posted: May 15, 2017
• Study Start: March 30, 2016
• Primary Completion (Estimated): January 1, 2036
• Study Completion (Estimated): January 1, 2036
• Last Updated: May 15, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)