Longevity in Russia

Aging Clinical Trial

Official title:

Healthy Longevity and Mortality in Long-living Adults: Contributors and Causes - Lifestyle, Socioeconomic Background, and Replicative Aging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06268132
• Other study ID #: MLS90
• Status: Recruiting
• Start date: December 25, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Center for Strategic Planning, of the Federal Medical and Biological Agency
• Contact: Daria A. Kashtanova, M.D., Ph.D
• Phone: +74955406171
• Email: DKashtanova[@]cspfmba.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational cohort study of long-living adults (participants aged 90 and above) from the Central Federal District of Russia. The study seeks to determine the genetic and cellular and molecular determinants of healthy longevity and to assess the impact of lifestyle and socioeconomic and environmental factors on healthy longevity. The study is expected to result in the development of a panel of markers of healthy longevity and/or a model of healthy aging based on the analysis of all factors under consideration.

Description:

The study involves a long-term observation of a cohort of long-living adults. During the first visit, a medical professional will take a detailed medical history and perform a comprehensive geriatric assessment (for 15 geriatric syndromes), and physical examination. The participants will have their biomaterials sampled for basic and extended blood biochemistry testing, telomere length measurement, common urine tests and subsequent biobanking and additional studies: whole genome sequencing, DNA methylation analysis, transcriptome analysis, and 16S RNA sequencing of stool and saliva. Follow-up checks will be carried out once a year by phone or during additional visits. The study seeks to identify the genetic, epigenetic, and metagenomic determinants associated with the successful and unsuccessful aging phenotypes, mortality, and survival in long-living individuals.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 90 Years and older

Eligibility

Inclusion Criteria:

• Informed consent
• 90 years of age or above

Exclusion Criteria:

• Refusal to participate or to provide informed consent;
• Any other criteria deemed reasons for exclusion by the Principal Investigator.

Related Conditions & MeSH terms

• Age-related Cognitive Decline
• Aging
• Aging Disorder
• Cognitive Dysfunction
• Frailty
• LONGEVITY 1

Locations

Country	Name	City	State
Russian Federation	RUSSIAN CLINICAL AND RESEARCH CENTER OF GERONTOLOGY, Pirogov Russian National Research Medical University of the Ministry of Healthcare of the Russian Federation	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
Center for Strategic Planning, of the Federal Medical and Biological Agency	Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality among long-living adults	Mortality among long-living adults within at least 1 year after inclusion in the study and factors associated with mortality will be assessed.	at least 1 year after inclusion in the study
Primary	Morbidity among long-living adults	Morbidity among long-living adults within at least 1 year after inclusion in the study and factors associated with morbidity will be assessed.	at least 1 year after inclusion in the study
Secondary	Aging phenotypes	Identification of successful and unsuccessful aging phenotypes	at least 2 years after inclusion in the study
Secondary	Social, economic, and medical- history-related determinants	Identification of social, economic, and medical- history-related determinants of successful and unsuccessful aging, geriatric syndromes	at least 2 years after inclusion in the study
Secondary	Genetic determinants	Identification of the genetic determinants of successful and unsuccessful aging, geriatric syndromes	at least 2 years after inclusion in the study
Secondary	Epigenetic determinants	Identification of the epigenetic determinants (methylation sites) of successful and unsuccessful aging, geriatric syndromes	at least 2 years after inclusion in the study
Secondary	Metagenomic determinants	Identification of the metagenomic determinants (16S-rSeq) of successful and unsuccessful aging, geriatric syndromes	at least 2 years after inclusion in the study