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HealthyWellderlyNCT01004133

The Healthy Elderly Longevity Cohort

An observational study of Healthy, run by Scripps Translational Science Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 80 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
How many people
5,000 participants
Where
1 siteUnited States
Study dates
Aug 2007to Jan 2030
Phase
Observational
Are there results?
Not yet: the study is under way

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 80 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Study population: General outpatient and community population.

Who may be able to join

  • 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)
Show all 12Show fewer
  • 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)

Who cannot join

  • < 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
Show all 19Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Emily Spencer, PhD contact

858-784-2029

egspence@scripps.edu

United States1 site, 1 recruiting
  • Scripps Translational Science Institute

    La Jolla, California, 92037

    Sarah Topol, BSN, RN, 858-554-5747, topol.sarah@scrippshealth.org

    Eric J Topol, MD

    Recruiting

Other trials in United States

About this study

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.

Read more

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.

Conditions
Healthy
Keywords
Age 80 or older, No chronic disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01004133
Study groupRoleWhat they receive
Subjects 80 years of age or older without chronic diseases.Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biorepository Creation

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

    Measured: ten years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2009 (estimated)
  2. Study startAug 2007
  3. Primary completionJan 2030 (estimated)
  4. Study completionJan 2030 (estimated)

Resources

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
Other
Time perspective
Other
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01004133
Sponsor's protocol ID
HSC 07-4789
Acronym
Wellderly
Status last verified
Jan 2025
First submitted
27 Oct 2009
Last updated
17 Jan 2025
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by Scripps Translational Science Institute at 1 site in United States.

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 12 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 17 Jan 2025. 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 United States. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sarah Topol, BS (858-784-2155, topol.sarah@scrippshealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biorepository Creation (time frame: ten years). 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 17 Jan 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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