Wellderly Immune Antibodies Study, a Sub-Study of Healthy Elderly Active Longevity (HEAL) Cohort

Wellderly Immune Antibodies Study, a Sub-Study of Healthy Elderly Active Longevity (HEAL) Cohort (HSC# 004789)

The aim of this sub-study is to determine whether healthy individuals over 90 years of age possess immune cells that are involved in protection from chronic disease. The immune system is well known to produce anti-cancer and other immune cells, called antibodies that can be beneficial to our health. In this study the investigators will evaluate the immune status of the healthy individuals over 90 years of age. The investigators will be focused on studying molecules known to be involved in cholesterol, cancer like those for prostate cancer and breast cancer, inflammatory diseases, and infectious diseases like influenza.

Study Overview

• Status: Completed
• Conditions: Antibodies Involved in Healthy Aging

Detailed Description

The aim of this sub-study is to determine whether the Wellderly posess neutralizing antibodies targeting antigens involved in chronic disease. The humoral immune system is well known to produce anti-cancer and other antibodies that can be long lived in vivo. In this study we will evaluate the antibody status of the Wellderly with respect to neutralizing (i) molecules known to induce cholesterol like PCSK9, (ii) antibodies against cancer antigens like PMSA (prostate cancer) or Her2 (Breast cancer), (iii) antibodies against inflammatory molecules like TNFa or IL-6, (iv) antibodies that have broad neutralizing activity against infectious diseases like influenza.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Scripps Translational Science Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 90 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Age 90 and over Gender: Male and Female Enrolled in the Healthy Elderly (HEAL) study prior to enrollment in this sub-study

Description

INCLUSION CRITERIA

1. Age 90 and over
2. Gender: Male and Female
3. Enrolled in the Healthy Elderly (HEAL) study prior to enrollment in this sub-study
4. Eligible for Blood draw
5. Be reliable, cooperative and willing to comply with all protocol-specified procedures.
6. Able to understand and grant informed consent

7. Be healthy or have mild medical conditions that may be associated with the normal aging process, including:

   • Hypertension, well controlled with no more than 3 medications
   • Osteoporosis or Osteopenia
   • Osteoarthritis
   • Benign Prostatic Hypertrophy
   • Cataracts, Glaucoma or Macular Degeneration
   • Dyslipidemia
   • Hypothyroidism
   • Pre-Diabetes/Impaired Fasting Glucose (fasting blood glucose 100-126 mg/dL, if known)
   • Basal or Squamous Cell Carcinoma

Individuals will be excluded if ANY of the following conditions apply:

EXCLUSION CRITERIA

1. Less than 90 years of age
2. Currently undergoing treatment with any investigational agents or devices within 30 preceding enrollment in this study.

3. Self-reported history or current diagnosis of significant chronic conditions including:

   • Any Cancer (including polycythemia; excluding basal or squamous cell carcinoma
   • Coronary Artery Disease, Myocardial Infarction
   • Stroke or Transient Ischemic Attack (TIA)
   • Deep Vein Thrombosis or Pulmonary Embolism
   • Chronic Renal Disease or Hemodialysis
   • Significant Auto-Immune or Inflammatory conditions such as Rheumatoid Arthritis, Lupus, Crohn's Disease, etc.
   • Alzheimer's or Parkinson's Disease
   • Diabetes (Hemoglobin A1C > 6.5% or fasting glucose > 126 mg/dL or is treated with insulin or oral diabetic medication
   • Aortic or Cerebral Aneurysm

4. Currently taking any of the following medications on a regular basis:

   • Chemotherapeutic agents (ex. Tamoxifen, Doxorubicin, Mitoxantrone, bleomycin
   • Anti-platelet or anticoagulant agents, not including Aspirin (ex. Clopidogrel/Plavix, Dipyridamole/Aggrenox/Persantine, Ticlopidine/Ticlid, Warfarin/Coumadin, Prasugrel, etc.)
   • Cholinesterase inhibitor for Alzheimer's disease (ex. Donzepril/Aricept)
   • Insulin or oral diabetic medication
5. Individual has a significant medical condition which, in the investigator's opinion, may interfere with the individual's optimal participation in the study or would potentially confound interpretation of the individual's phenotype.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Healthy Elderly; Age 90 and over Gender: Male and Female Enrolled in the Healthy Elderly (HEAL) study prior to enrollment in this sub-study Blood sample of approximately 20mL is drawn.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibodies targeting antigens involved in chronic disease	We have made phage display libraries from the antibody genes derived from Wellderly B-cells. Remarkably, we could identify specific antibodies against several targets involved in multiple chronic diseases including PCSK9, inflammatory cytokines, and influenza hemaglutinin. We hypothesize that the Wellderly may contain antibodies targeting antigens involved in chronic disease, and that these antibodies may be protective and health-promoting.	up to 2 years

Collaborators and Investigators

• Sponsor: Scripps Translational Science Institute
• Investigators: Principal Investigator: Eric Topol, MD, Scripps

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: March 19, 2013
• First Submitted That Met QC Criteria: March 21, 2013
• First Posted (Estimate): March 22, 2013

Study Record Updates

• Last Update Posted (Estimate): October 16, 2015
• Last Update Submitted That Met QC Criteria: October 14, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: Wellderly Immune Antibodies