Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT01004133
Eligibility Criteria:
Inclusion Criteria:
1. Age 80 years or older
2. Eligible for blood draw and/or saliva collection
3. Be reliable, cooperative and willing to comply with all protocol-specified procedures
4. Able to understand and grant informed consent
5. 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:
1. \< 80 years old
2. Participants have been previously enrolled in The Scripps Genebank Healthy Elderly Cohort
3. Treatment with any investigational agents or devices within thirty days preceding enrollment in the study.
4. 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
5. 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
6. 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
80 Years
Study:
NCT01004133
Study Brief:
Protocol Section:
NCT01004133