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:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT04566757
Eligibility Criteria:
Inclusion Criteria:
1. Age 65-85 years old
2. Evidence of cognitive decline on neuro-cognitive testing
3. Able to participate in research trial for 12 months
4. Women must have documented menopause or infertility determination
5. Ability to receive intravenous infusions
6. Patient or legally authorized representative able to sign informed consent
Exclusion Criteria:
1. Patients receiving any other investigational biologics or drugs
2. History of transfusion reaction
3. Dementia related to specific pathology (Alzheimer's Disease, Alcohol-related, etc.)
4. Inability to participate in cognitive or performance testing
5. History of cancer in the last 5 years
6. History of infectious disease within the previous 12 months
7. Severe kidney (eGFR\< 30) and heart failure (Class III/IV)
8. History of Human Immunodeficiency Virus Infection
9. History of Hepatitis B, or C
10. History of immunosuppressive therapy
11. History of organ transplantation
12. Difficulty of obtaining peripheral venous access
13. Allergy to histamine blockers
14. Inability to participate in the clinical trial at any data collection and end points
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Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
85 Years
Study:
NCT04566757
Study Brief:
Protocol Section:
NCT04566757