AgingAGE-100NCT02876809
A Model for Healthy Aging: Moscow Centenarians (AGE-100)
An observational study of Aging, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial summary
This study evaluates the associations between biomarkers of ageing, comprehensive geriatric status, telomere length and progerin level, the composition of the gut microbiota, 16sRNA metagenome sequencing in Moscow centenarians. Read more about this study
- Who is it for?
- Ages 90 years and older
- Conditions the study is for
- Aging
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- Oct 2016to Mar 2021
- 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 90 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Population consists of 100-age Moscow long-livers chosen according to data of Moscow clinics.
Who may be able to join
- age over 90 years
- -
Who cannot join
- age under 90 years refusal to participate in the study
- -
Trial locations and contacts
1 site in 1 country.
Russia1 site
Pirogov Russian National Research Medical University of the Ministry of Health of the Russian Federation, Russian Gerontology Clinical Research Center
Moscow, 115162
About this study
This study evaluates the associations between biomarkers of ageing, comprehensive geriatric status, telomere length and progerin level, the composition of the gut microbiota, 16sRNA metagenome sequencing in Moscow centenarians.
Read the detailed description
The global average life expectancy and the average age of the population are growing steadily along with the age-related diseases. The same trend is also observed in our country. Although, maximum life span in Russia decreases. E.g., the number of centenarians in Moscow decreased by 244 persons from 2013 to 2014. There were about 400 centenarians in Moscow in 2014. That is about 3.3 per 100 000 population. In the US, this figure is about 10-20, and there are 50 centenarians per 100 000 population in the Okinawa region, Japan. The rate of ageing varies substantially, a prime example of this is the centenarians population. These people break conventional stereotypes about aging. Chronic diseases in centenarians are postponed. They are more active, they work longer, they can better tolerate stressful situations. Scientists all over the world are trying to find the secret of their longevity. Studies on the medical and social aspects of centenarian longevity are actively carried out in the US, Europe, Japan, Australia. In Russia studies were carried out in St. Petersburg, Western and Eastern Siberia. According to the New England Centenarian Study, the supercentenarians (persons who have lived more than 110 years) life span is actually equal to the healthy span without serious illnesses. The aim of research is to study features of social status, lifestyle, habits, clinical status, blood chemistry, the amount of progerin, genome, composition of the gut microbiota in Moscow centenarians in order to create a model of healthy aging. In this study a comprehensive analysis of the longevity phenomenon of one hundred centenarians from Moscow and the Moscow region planning to be conducted. Analyzing of anamnesis vitae, medical, social, neuro-cognitive, and genetic features is planning. Each study participant will undergo a comprehensive geriatric assessment, including examination by the neurologist, an assessment of cognitive status,psychogeriatric consultation with the assessment of self-perceptions of aging and depression assessment by using the geriatric depression scale, neuropsychological testing using the Montreal Cognitive Assessment (MoCA), verbal recognition memory 12 word test, clock-drawing test.Telomere length and progerin level in buffy coat layer evaluation, 16sRNA metagenome sequencing, and nuclear magnetic resonance spectroscopy for qualitative and quantitative analysis of metabolites in blood serum, will be done in all participants. This study will take the science closer to the goal of identifying the patterns of "healthy" aging.
- Conditions
- Aging
- Keywords
- centenarians, geriatric, telomere length, progerin, metagenome, metabolome
- Medical subject headings
- Autosomal Emery-Dreifuss Muscular Dystrophy
What is being measured
The primary outcome is the main question the study is designed to answer.
Definition of frailty prevalence among 100-Centenarians
Frailty will be measured by comprehensive geriatric assessment, including examination by the neurologist, an assessment of cognitive status,psychogeriatric consultation with the assessment of self-perceptions of aging and depression assessment by using the geriatric depression scale, neuropsychological testing using the Montreal Cognitive Assessment (MoCA), verbal recognition memory 12 word test, clock-drawing test
Measured: 0 month
Secondary outcomes (2)
Definition of telomere biology status
Relative telomere length in genomic DNA and telomerase activity in monocytes will be assessed by real-time PCR.
Measured: 0 month
Definition of vascular aging
Vascular aging will be measured by intima-media thickness measurement and plaque presence determination by ultrasonography in both left and right common carotid arteries. Arterial stiffness will be assess by aortic pulse wave velocity measuring by SphygmoCor.
Measured: 0 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2021
- Study completionMar 2021
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olga N. Tkacheva, Professor, Principal investigator, Russian Gerontology Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876809
- Sponsor's protocol ID
- MCA-100
- Acronym
- AGE-100
- Status last verified
- Mar 2021
- First submitted
- 15 Aug 2016
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Model for Healthy Aging: Moscow Centenarians (AGE-100)
- ClinicalTrials.gov ID
- NCT02876809
- Acronym / sponsor ID
- AGE-100 / MCA-100
- Conditions
- Aging
- Keywords
- centenarians, geriatric, telomere length, progerin, metagenome, metabolome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Mar 2021 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 24 Aug 2016 (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.
This study evaluates the associations between biomarkers of ageing, comprehensive geriatric status, telomere length and progerin level, the composition of the gut microbiota, 16sRNA metagenome sequencing in Moscow centenarians.
Detailed description
The global average life expectancy and the average age of the population are growing steadily along with the age-related diseases. The same trend is also observed in our country. Although, maximum life span in Russia decreases. E.g., the number of centenarians in Moscow decreased by 244 persons from 2013 to 2014. There were about 400 centenarians in Moscow in 2014. That is about 3.3 per 100 000 population. In the US, this figure is about 10-20, and there are 50 centenarians per 100 000 population in the Okinawa region, Japan. The rate of ageing varies substantially, a prime example of this is the centenarians population. These people break conventional stereotypes about aging. Chronic diseases in centenarians are postponed. They are more active, they work longer, they can better tolerate stressful situations. Scientists all over the world are trying to find the secret of their longevity. Studies on the medical and social aspects of centenarian longevity are actively carried out in the US, Europe, Japan, Australia. In Russia studies were carried out in St. Petersburg, Western and Eastern Siberia. According to the New England Centenarian Study, the supercentenarians (persons who have lived more than 110 years) life span is actually equal to the healthy span without serious illnesses. The aim of research is to study features of social status, lifestyle, habits, clinical status, blood chemistry, the amount of progerin, genome, composition of the gut microbiota in Moscow centenarians in order to create a model of healthy aging. In this study a comprehensive analysis of the longevity phenomenon of one hundred centenarians from Moscow and the Moscow region planning to be conducted. Analyzing of anamnesis vitae, medical, social, neuro-cognitive, and genetic features is planning. Each study participant will undergo a comprehensive geriatric assessment, including examination by the neurologist, an assessment of cognitive status,psychogeriatric consultation with the assessment of self-perceptions of aging and depression assessment by using the geriatric depression scale, neuropsychological testing using the Montreal Cognitive Assessment (MoCA), verbal recognition memory 12 word test, clock-drawing test.Telomere length and progerin level in buffy coat layer evaluation, 16sRNA metagenome sequencing, and nuclear magnetic resonance spectroscopy for qualitative and quantitative analysis of metabolites in blood serum, will be done in all participants. This study will take the science closer to the goal of identifying the patterns of "healthy" aging.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 90 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Population consists of 100-age Moscow long-livers chosen according to data of Moscow clinics.
Key inclusion criteria (2 listed)
- age over 90 years
- -
Key exclusion criteria (2 listed)
- age under 90 years refusal to participate in the study
- -
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
Definition of frailty prevalence among 100-Centenarians
Time frame: 0 month
Frailty will be measured by comprehensive geriatric assessment, including examination by the neurologist, an assessment of cognitive status,psychogeriatric consultation with the assessment of self-perceptions of aging and depression assessment by using the geriatric depression scale, neuropsychological testing using the Montreal Cognitive Assessment (MoCA), verbal recognition memory 12 word test, clock-drawing test
2 secondary outcomes
Definition of telomere biology status
Time frame: 0 month
Definition of vascular aging
Time frame: 0 month
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 23 Mar 2021.
- This novel approach support the hypothesis that a complex remodeling of lipid, amino acid metabolism, and of gut microbiota functionality are key regulatory processes marking exceptional longevity in humans.Link provided by the sponsor.
- While some centenarians have poor health and functioning upon reaching age 100, others are able to achieve exceptional longevity in relatively good health and without loss of functioning.Link provided by the sponsor.
- Available data indicate improved DNA repair and antioxidant defense mechanisms in "super old" humans, which are comparable with much younger cohorts.Link provided by the sponsor.
- Results suggest that a better preservation of DNA methylation status, a slower cell growing/metabolism, and a better control in signal transmission through epigenetic mechanisms may be involved in the process of human longevity.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Olga N. Tkacheva, Professor principal investigator
Russian Gerontology Clinical Research Center
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, run by Pirogov Russian National Research Medical University at 1 site in Russia.
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 2 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 23 Mar 2021. 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 Russia. 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.
What does the primary outcome measure?
Definition of frailty prevalence among 100-Centenarians (time frame: 0 month). It is what the study was designed to measure, not a finding.
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 23 Mar 2021.