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

Aging Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01590706
• Other study ID #: KC1101
• Status: Completed
• Phase: N/A
• First received: May 1, 2012
• Last updated: April 1, 2014
• Start date: November 2011
• Est. completion date: March 2013

Study information

• Verified date: April 2014
• Source: Korea Institute of Oriental Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Education, Science, and Technology
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: March 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Aging
• Angina Pectoris
• Cognition Disorders
• Mild Cognitive Impairment

Locations

Country	Name	City	State
Korea, Republic of	Dunsan Oriental Hospital of Daejeon Univ.	Daejeon

Sponsors (2)

Lead Sponsor	Collaborator
Korea Institute of Oriental Medicine	Daejeon University

Country where clinical trial is conducted

Korea, Republic of,