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


N/A
90 Years
N/A
Open (Enrolling by invite only)
Both
Antibodies Involved in Healthy Aging

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Trial Information

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 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.

Inclusion Criteria


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Antibodies targeting antigens involved in chronic disease

Outcome Description:

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.

Outcome Time Frame:

up to 2 years

Safety Issue:

No

Principal Investigator

Eric Topol, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Scripps

Authority:

United States: Institutional Review Board

Study ID:

Wellderly Immune Antibodies

NCT ID:

NCT01816880

Start Date:

June 2012

Completion Date:

Related Keywords:

  • Antibodies Involved in Healthy Aging

Name

Location

Scripps Translational Science Institute La Jolla, California  92037