PEARL: Participatory Evaluation (of) Aging (With) Rapamycin (for) Longevity Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Rapamycin 5 Rapamycin 5 mg/week |
Drug: Rapamycin
Rapamycin in 2 different dosage forms.
Other Names:
|
| Experimental: Rapamycin 10 Rapamycin 10 mg/week |
Drug: Rapamycin
Rapamycin in 2 different dosage forms.
Other Names:
|
| Placebo Comparator: Placebo 1 Placebo once per week |
Drug: Placebo
Placebo capsules
|
Outcome Measures
Primary Outcome Measures
- Changes in visceral fat as measured by dual-energy x-ray absorptiometry (DXA) scan [6 month interim analysis of the data, 12 month safety profile will be established]
Visceral fat changes from baseline as determined by DXA scan.
Secondary Outcome Measures
- bone density [6 month interim analysis of the data, 12 month safety profile will be established]
Changes in bone density from baseline as determined by DXA scan
- lean body mass [6 month interim analysis of the data, 12 month safety profile will be established]
Changes in lean body mass from baseline as determined by DXA scan
- adverse events [6 month interim analysis of the data, 12 month safety profile will be established]
Number of patients with adverse events using standard AE reporting (FDA regulations 21CFR314.80 and 1CFR213.32(s))
- complete blood count (CBC) [6 month interim analysis of the data, 12 month safety profile will be established]
changes in CBC from baseline
- Change of blood electrolytes（serum potassium, sodium, chloride, and carbon dioxide in mmol/L）measured at baseline and after 6 and 12 months. [6 month interim analysis of the data, 12 month safety profile will be established]
Difference in the change of blood electrolytes（serum potassium, sodium, chloride, and carbon dioxide in mmol/L) compared with the baseline at 6 and 12 months between the intervention and control group is to be analyzed.
- Change of liver function as measured by serum globulin in g/dL, measured at baseline and after 6 and 12 months. [6 month interim analysis of the data, 12 month safety profile will be established]
Difference in the change of liver function as measured by serum globulin in g/dL compared with the baseline at 6 and 12 months between the intervention and control group is to be analyzed.
- Change of liver function as measured by serum bilirubin in mg/dL, measured at baseline and after 6 and 12 months. [6 month interim analysis of the data, 12 month safety profile will be established]
Difference in the change of liver function as measured by serum bilirubin in mg/dL compared with the baseline at 6 and 12 months between the intervention and control group is to be analyzed.
- Change of liver function as measured by serum alkaline phosphatase, AST, and ALT in IU/L, measured at baseline and after 6 and 12 months. [6 month interim analysis of the data, 12 month safety profile will be established]
Difference in the change of liver function as measured by serum alkaline phosphatase, AST, and ALT in IU/L compared with the baseline at 6 and 12 months between the intervention and control group is to be analyzed.
- Change of renal function as measured by serum albumin in g/dL, measured at baseline and after 6 and 12 months. [6 month interim analysis of the data, 12 month safety profile will be established]
Difference in the change of renal function as measured by serum albumin in g/dL compared with the baseline at 6 and 12 months between the intervention and control group is to be analyzed.
- Change of renal function as measured by serum creatinine and uric acid in mg/dL, measured at baseline and after 6 and 12 months. [6 month interim analysis of the data, 12 month safety profile will be established]
Difference in the change of renal function as measured by serum creatinine and uric acid in mg/dL compared with the baseline at 6 and 12 months between the intervention and control group is to be analyzed.
- Change in lipids (serum total cholesterol, triglycerides, HDL, and LDL cholesterol in mg/dL) measured at baseline and after 6 and 12 months. [6 month interim analysis of the data, 12 month safety profile will be established]
Difference in the change of lipids（serum total cholesterol, triglycerides, HDL and LDL cholesterol in mg/dL) compared with the baseline at 6 and 12 months between the intervention and control group is to be analyzed.
- Change in fasting serum glucose in mg/dL, measured at baseline and after 6 and 12 months. [6 month interim analysis of the data, 12 month safety profile will be established]
Difference in the change of fasting serum glucose in mg/dL compared with baseline at 6 and 12 months between the intervention and control group is to be analyzed.
- Change in insulin in uIU/mL, measured at baseline and after 6 and 12 months. [6 month interim analysis of the data, 12 month safety profile will be established]
Difference in the change of fasting serum insulin in uIU/mL compared with baseline at 6 and 12 months between the intervention and control group is to be analyzed.
- Change in fasting serum IGF-1 in ng/mL, measured at baseline and after 6 and 12 months. [6 month interim analysis of the data, 12 month safety profile will be established]
Difference in the change of fasting serum IGF-1 in ng/mL compared with baseline at 6 and 12 months between the intervention and control group is to be analyzed.
- Change in serum Hemoglobin A1c in % of total hemoglobin, measured at baseline and after 6 and 12 months. [6 month interim analysis of the data, 12 month safety profile will be established]
Difference in the change of serum Hemoglobin A1c in % of total hemoglobin compared with baseline at 6 and 12 months between the intervention and control group is to be analyzed.
Eligibility Criteria
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.)
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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
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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
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AgelessRx | Chicago | Illinois | United States | 60605 |
Sponsors and Collaborators
- AgelessRx
- University of California, Los Angeles
Investigators
- Principal Investigator: James Watson, MD, University of California, Los Angeles
- Study Director: Sajad Zalzala, MD, AgelessRx
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ALRx001