Status:
COMPLETED
Participatory Evaluation (of) Aging (With) Rapamycin (for) Longevity Study
Lead Sponsor:
AgelessRx
Collaborating Sponsors:
University of California, Los Angeles
Conditions:
Aging
Eligibility:
All Genders
50-85 years
Phase:
PHASE2
Brief Summary
This is a randomized, placebo-controlled trial into the safety and efficacy in reducing clinical measures of aging in an older adult population.
Detailed Description
A randomized, double-blind, placebo-controlled trial assessing the effects of low and high doses of intermittent Rapamycin on a weekly schedule. The researchers aim to establish a long-term safety pro...
Eligibility Criteria
Inclusion
- Age 50-85
- Any sex
- Any ethnicity
- Interest in taking Rapamycin off-label
- Willing to undergo tests
- Relatively good health with only well-managed chronic diseases (hypertension, coronary artery disease, type II diabetes, etc.) clinically stable
- Adequate cognitive function to be able to give informed consent
- Technologically competent to complete web forms and perform video calls with the PI
Exclusion
- Anemia - Hg \< 9.0 g/dl, Leukopenia - white blood cells (WBC) \< 3,500/mm3 , Neutropenia - absolute neutrophil count \< 2,000/mm3 , or Platelet count - platelet count \< 125,000/mm3
- Premenopausal females (due to menstruation-induced anemia, etc.)
- Patients scheduled to undergo major surgery in the next 12 months
- Patients undergoing or scheduled to undergo chemotherapy or any other treatment for malignancy
- Patients scheduled for immunosuppressant therapy for transplant
- Patients with impaired wound healing or history of a chronic open wound
- Untreated dyslipidemia with LDL-c \> 190 and family history of dyslipidemia, Total cholesterol \> 350 mg/dl, or triglycerides \> 880 mg/dl.
- Impaired hepatic function, including elevated alkaline Phosphatase levels, aspartate aminotransferase (AST), alanine aminotransferase (ALT), Albumin, or T. Bili.
- HIV/AIDS, chronic Lyme, Babesia, Ehrlichiosis, Anaplasmosis, or other chronic infections that require ongoing treatment or monitoring
- Allergy to Rapamycin
- Any form of clinically relevant primary or secondary immune dysfunction or deficiency (e.g. X-linked agammaglobulinemia (XLA), common variable immunodeficiency (CVID))
- Chronic oral corticosteroid or immunosuppressive medication use (e.g. Enbrel, Humira, methotrexate).
- Fibromyalgia or Chronic Fatigue Syndrome/Myalgic Encephalomyelitis, Breast Implant Illness,
- Congestive heart failure: self-assessed functional status of heart failure New York Heart Association (NYHA) classification III or IV
- Impaired renal function, as defined as glomerular filtration rate (GFR) \< 30
- Poorly controlled diabetes, as defined as HbA1c \> 7%
- Type I Diabetes, or Insulin-dependent Type II diabetes
- Substance abuse disorder either untreated or if treated within the last 5 years
- PTSD, Bipolar disorder, Schizophrenia, or any other untreated or poorly controlled mental health or mood disorder, or history of hospitalization due to mental health condition
- Those who have taken metformin, rapamycin, or rapalogs in the past 6 months
- (volunteers who were on metformin for aging can participate, provided they agree to stop taking metformin before and during the trial)
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT04488601
Start Date
January 1 2020
End Date
December 30 2023
Last Update
January 24 2024
Active Locations (1)
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1
AgelessRx
Chicago, Illinois, United States, 60605