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

NCT ID: NCT01590706

Last Updated: 2014-04-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 116 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-03-31

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.

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.

Conditions

Aging; Mild Cognitive Impairment; Angina Pectoris

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Daejeon University

OTHER

Sponsor Role: collaborator

Korea Institute of Oriental Medicine

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dal-Seok Oh, OMD, PhD

Senior Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miyoung Lee, PhD

Role: STUDY_DIRECTOR

Korea Institute of Oriental Medicine

Locations

Dunsan Oriental Hospital of Daejeon Univ.

Daejeon, , South Korea

Countries

South Korea

Other Identifiers

KC1101

Identifier Type: -

Identifier Source: org_study_id