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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, placebo-controlled trial into the safety and efficacy in reducing clinical measures of aging in an older adult population.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AgelessRx
• Collaborator: University of California, Los Angeles
• Treatments: Sirolimus

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)