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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01590706
Recruitment Status : Completed
First Posted : May 3, 2012
Last Update Posted : April 2, 2014
Daejeon University
Information provided by (Responsible Party):
Dal-Seok Oh, OMD, PhD, Korea Institute of Oriental Medicine

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
Aging Mild Cognitive Impairment Angina Pectoris

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.

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Study Type : Observational
Estimated 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 : November 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : March 2013

Biospecimen Retention:   Samples With DNA
Samples for single nucleotide polymorphism, and for cardiac enzyme level detection

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy middle aged (45-64 age) and elderly (over 65 age) person

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01590706

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Korea, Republic of
Dunsan Oriental Hospital of Daejeon Univ.
Daejeon, Korea, Republic of, 302122
Sponsors and Collaborators
Korea Institute of Oriental Medicine
Daejeon University
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Study Director: Miyoung Lee, PhD Korea Institute of Oriental Medicine

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Responsible Party: Dal-Seok Oh, OMD, PhD, Senior Investigator, Korea Institute of Oriental Medicine Identifier: NCT01590706     History of Changes
Other Study ID Numbers: KC1101
First Posted: May 3, 2012    Key Record Dates
Last Update Posted: April 2, 2014
Last Verified: April 2014
Keywords provided by Dal-Seok Oh, OMD, PhD, Korea Institute of Oriental Medicine:
Genotype-Phenotype Association
Middle Aged
Mild Cognitive Impairment
Heart Rate Control
Additional relevant MeSH terms:
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Angina Pectoris
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Neurologic Manifestations
Signs and Symptoms