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

Completed · Phase 2 · Has a placebo group

Conditions studied: Aging

In brief

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

Key facts

Study ID

NCT04488601

Run by

AgelessRx

People needed

129

Starts

2020-01-01

Expected to finish

2023-12-30

Last updated by the study team

2024-01-24

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• AgelessRx — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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