NCT03152630 Research on the Early and Prognosis Diagnosis of Vascular Dementia
| NCT ID | NCT03152630 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Taiwan University Hospital |
| Condition | Dementia |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2016-03-30 |
| Primary Completion | 2036-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2016-03-30 with a primary completion date of 2036-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * not willing to sign ICF
Contact & Investigator
Chau C Wu, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
National Taiwan University Hospital
Frequently Asked Questions
Who can join the NCT03152630 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03152630 currently recruiting?
Yes, NCT03152630 is actively recruiting participants. Contact the research team at chauchungwu@ntu.edu.tw for enrollment information.
Where is the NCT03152630 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT03152630 clinical trial?
NCT03152630 is sponsored by National Taiwan University Hospital. The principal investigator is Chau C Wu, M.D., Ph.D. at National Taiwan University Hospital. The trial plans to enroll 600 participants.