AgingNCT01590706
A Study of Characterizing Cognitive Decline and Functional Cardiac Senescence in Healthy Korean Volunteers
An observational study of Aging and Mild Cognitive Impairment, run by Korea Institute of Oriental Medicine at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Mild Cognitive Impairment, Angina Pectoris
- How many people
- 116 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2011to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy middle aged (45-64 age) and elderly (over 65 age) person
Who may be able to join
- Healthy subjects >= 45 and <= 80 years of age
- who understands the study procedures signs informed consent forms
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Dunsan Oriental Hospital of Daejeon Univ.
Daejeon, 302122
About this study
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
- 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.
Read the 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,
- additional demographic interview including covariate factors (depression status, marital status
- vital sign check
- the questionnaire for cognitive function
- blood draw for genomic, proteomic, and metabolomic analyses (10 milli Liter), urine collection (20 milli Liter)
- 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
- Keywords
- Genotype-Phenotype Association, Aged, Middle Aged, Mild Cognitive Impairment, Heart Rate Control, Biomarkers
- Medical subject headings
- Cognitive Dysfunction, Angina Pectoris
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startNov 2011
- Primary completionOct 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea Institute of Oriental Medicine
- Sponsor type
- Other government
- Collaborators
- Daejeon University
- Responsible party
- Principal investigator, Dal-Seok Oh, OMD, PhD, Korea Institute of Oriental Medicine
- Investigators
- Miyoung Lee, PhD, Study director, Korea Institute of Oriental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590706
- Sponsor's protocol ID
- KC1101
- Status last verified
- Apr 2014
- First submitted
- 1 May 2012
- Last updated
- 2 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01590706
- Acronym / sponsor ID
- KC1101
- Conditions
- Aging, Mild Cognitive Impairment, Angina Pectoris
- Keywords
- Genotype-Phenotype Association, Aged, Middle Aged, Mild Cognitive Impairment, Heart Rate Control, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Korea Institute of Oriental MedicineOther government
- Collaborators
- Daejeon University
- Study start
- Nov 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 3 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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,
- additional demographic interview including covariate factors (depression status, marital status
- vital sign check
- the questionnaire for cognitive function
- blood draw for genomic, proteomic, and metabolomic analyses (10 milli Liter), urine collection (20 milli Liter)
- 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
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy middle aged (45-64 age) and elderly (over 65 age) person
Key inclusion criteria (2 listed)
- Healthy subjects >= 45 and <= 80 years of age
- who understands the study procedures signs informed consent forms
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miyoung Lee, PhD study director
Korea Institute of Oriental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Mild Cognitive Impairment, run by Korea Institute of Oriental Medicine at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2014.