Participatory Evaluation (of) Aging (With) Rapamycin (for) Longevity Study

Launched by AGELESSRX · Jul 26, 2020

Keywords

ClinConnect Summary

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 profile, determine the long-term efficacy of Rapamycin in reducing clinical aging measures, and biochemical and physiological endpoints associated with declining health and aging in healthy older adults.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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)