Recruiting

NCT Number: NCT01004133

The Healthy Elderly Longevity Cohort

With the completion of the human genome project, investigators can now explore new questions in human biology. Previously human genetics focused on highly penetrant, Mendelian traits; however, now rare and common variants can be discovered that affect "common" diseases that have multi-gene architecture with variable penetrance such as breast cancer, diabetes mellitus, and coronary artery disease. This change took place because investigators now have the tools to illuminate the whole genome at once to discover the genetic variants responsible for different disease phenotypes through statistical differences between populations. Besides disease phenotypes, health can be considered a human phenotype that can be studied. Health is not merely the absence of disease but may be viewed as a dynamic ongoing interplay between the environment and the genome to maintain homeostasis. Individuals often attempt to optimize environmental conditions according to ones genome to maximize their health. All individuals possess potentially beneficial and harmful variants depending on the environment. How this dynamic interplay occurs between the genome and environment requires understanding the boundary conditions of the genetic architecture of health and disease and then modeling the system to simulate the observed data.

The aging process also affects health. Aging involves a loss of the normal coping responses to internal and external environmental stressors or signals. Investigators now have the tools to uncover from the bottom up the mechanisms involved in maintaining the ability to overcome environmental conditions that can affect health.

Against this genomic breakthrough of whole genome association studies, the demographics in the United States are quickly changing. The older population (age > 65 years) in 2030 is projected to be twice as large as in 2000 representing nearly 20 percent of the total US population. The first baby boomers turn 65 in 2011 and will challenge all facets of health care in the coming decades. The demographic changes underscore the need to understand the mechanisms that promote health and disease in this cohort. Genomic discoveries will help individuals and may reduce medical costs and benefit society.

In summary, the objective of this study is to obtain blood and/or saliva samples in order to help model health and disease phenotypes through population genomics. The blood and/or saliva samples may allow for participants' entire genomes to be sequenced if such comprehensive analysis becomes feasible and economical.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Healthy

Age range

80 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Translational Science Institute

La Jolla, California, 92037, United States

Location status: Recruiting

Location contact

Eric J Topol, MD

CONTACT

Sarah Topol, BSN, RN

CONTACT

[email protected]

858-554-5747

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 80 years or older
Eligible for blood draw and/or saliva collection
Be reliable, cooperative and willing to comply with all protocol-specified procedures
Able to understand and grant informed consent
Be healthy or have mild medical conditions that may be associated with the normal aging process, including:

Hypertension, well controlled (no more than 3 medications)
Osteoporosis, Osteopenia and/or osteoarthritis
Benign prostatic hypertrophy
Cataracts, Glaucoma, Macular Degeneration
Dyslipidemia
Hypothyroidism
Pre-diabetes/impaired fasting glucose (fasting blood glucose 100-126 mg/dL, if known)

Exclusion criteria

< 80 years old
Participants have been previously enrolled in The Scripps Genebank Healthy Elderly Cohort
Treatment with any investigational agents or devices within thirty days preceding enrollment in the study.
Self-reported history or current diagnosis of significant chronic conditions including:

Any Cancer (including polycythemia; excluding basal or squamous cell skin cancer).
Coronary Artery Disease/Myocardial Infarction
Stroke/TIA
Deep Vein Thrombosis/Pulmonary Embolus
Chronic Renal Disease/Hemodialysis
Significant Auto-immune/Inflammatory conditions such as (Rheumatoid Arthritis, Lupus, Crohn's, etc.
Alzheimer's/Parkinson's
Diabetes (Hemoglobin A1C > 6.5 % or fasting glucose >126 mg/dL or treated with oral diabetic medication or insulin if known)
Aortic or Cerebral Aneurysm
Currently taking any of the following medications on a regular basis:

Oral chemotherapeutic agents (ex.: tamoxifen, doxorubicin, mitoxantrone, bleomycin)
Anti-platelet agents, not including aspirin (ex.: clopidogrel/plavix, dipyridamole/aggrenox/persantine, ticlopidine/ticlid)
Cholinesterase inhibitor for Alzheimer's disease (i.e. donepezil/Aricept)
Insulin
Subject has a significant medical condition which, in the Investigator's opinion, may interfere with the patient's optimal participation in the study or would potentially confound interpretation of the individual's phenotype.

Treatment and study plan

Primary outcomes

Biorepository Creation

Time frame: ten years

Create a biorepository from participants' blood and/or saliva donations we will ultimately be able to define genes for various diseases and understand health

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Spencer, PhD

CONTACT

[email protected]

858-784-2029

Sarah Topol, BS

CONTACT

[email protected]

858-784-2155

Sponsors and collaborators

Lead sponsor

Scripps Translational Science Institute

Other

Registry information

Acronym: Wellderly

Important dates

Study start: 2007
Primary completion: 2030
Study completion: 2030
First posted: Oct 29, 2009
Registry last updated: Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting