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A Study of Characterizing Cognitive Decline and Functional Cardiac Senescence in Healthy Korean Volunteers

Sponsor
Korea Institute of Oriental Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT01590706
Collaborator
Daejeon University (Other)
116
Enrollment
1
Location
16
Duration (Months)
7.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

  • Although aging process appears to be generally characterized, investigators have been paid much attention to the specific target molecules, which leads to discover the clinical markers of the senescence. The present study is to investigate the clinical and biological profile of cognitive decline and functional cardiac senescence in healthy middle aged and elderly Korean volunteers.

  • This study was conducted as a cross-sectional, single-center, comparative clinical study.

  • Each volunteer was given informed consent for checking cognition and cardiac function. Blood and urine samples were collected to analyze genome, proteome, and metabolome to assess cognition and cardiac function of its muscle enzymes.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    • The protocol of this study was developed as the first assessment of the three to four series of clinical research on senescence.

    • This design of the study is a non-interventional, single-center, single-visit design for investigating the cognitive decline and cardiac function including heart muscle enzyme activity, which have been considered one of the key points in aging process.

    • Volunteers visit the study site during the screening period, informed consent for study participation and blood draw are given respectively, then, the eligibilities are met, participants visit the study site just once within two weeks.

    • The participants undergo the following five procedures for 2-3 hours; out-patient visit,

    1. additional demographic interview including covariate factors (depression status, marital status

    2. vital sign check

    3. the questionnaire for cognitive function

    4. blood draw for genomic, proteomic, and metabolomic analyses (10 milli Liter), urine collection (20 milli Liter)

    5. electrocardiogram (ECG), then they are discharged.

    • Their safety follow-up is monitored in a week (± 1 day) by a phone-call from the study associates.

    • To evaluate cognitive function, several cognitive batteries were used, 3MSE (Modified-Mini Mental State Examination), ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale); for cognitive biomarkers, Apolipoprotein E, Type-3 metabotropic glutamate receptors.

    • To evaluate cardiac function including its enzyme activity: HRV (heart rate variability), CRP (c-reactive protein); Cardiac Troponin T.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    116 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    An Association Study of Characterizing Cognitive Decline and Functional Cardiac Senescence Profile Through the Association of Biomarkers and Clinical Outcomes in Healthy Middle Aged and Elderly Korean Volunteers
    Study Start Date :
    Nov 1, 2011
    Actual Primary Completion Date :
    Oct 1, 2012
    Actual Study Completion Date :
    Mar 1, 2013

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      45 Years to 80 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:

      • Healthy subjects >= 45 and <= 80 years of age

      • who understands the study procedures signs informed consent forms

      Exclusion Criteria:

      • who > 150 mmHg in systolic or < 95 mmHg in diastolic blood pressure

      • who > 110 mg/dl in fast glucose level

      • Smoking > 20 cigarettes/day

      • Alcohol > 3 units/day (1 unit = pure alcohol 10 milli Liter)

      • Caffeine > 5 cups of coffee or tea/day

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Dunsan Oriental Hospital of Daejeon Univ. Daejeon Korea, Republic of 302122

      Sponsors and Collaborators

      • Korea Institute of Oriental Medicine
      • Daejeon University

      Investigators

      • Study Director: Miyoung Lee, PhD, Korea Institute of Oriental Medicine

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Dal-Seok Oh, OMD, PhD, Senior Investigator, Korea Institute of Oriental Medicine
      ClinicalTrials.gov Identifier:
      NCT01590706
      Other Study ID Numbers:
      • KC1101
      First Posted:
      May 3, 2012
      Last Update Posted:
      Apr 2, 2014
      Last Verified:
      Apr 1, 2014
      Keywords provided by Dal-Seok Oh, OMD, PhD, Senior Investigator, Korea Institute of Oriental Medicine
      Genotype-Phenotype Association
      Aged
      Middle Aged
      Mild Cognitive Impairment
      Heart Rate Control
      Biomarkers
      Additional relevant MeSH terms:
      Angina Pectoris
      Cognitive Dysfunction

      Study Results

      No Results Posted as of Apr 2, 2014