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

AgelessRx

Status and phase: Completed; Phase 2

Conditions: Aging

Treatments: Drug: Rapamycin; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04488601

ALRx001

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 129 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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129 participants in 3 patient groups, including a placebo group

Rapamycin 5

Experimental group

Description:

Rapamycin 5 mg/week

Treatment:

Drug: Rapamycin

Rapamycin 10

Experimental group

Description:

Rapamycin 10 mg/week

Treatment:

Drug: Rapamycin

Placebo 1

Placebo Comparator group

Description:

Placebo once per week

Treatment:

Drug: Placebo