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

NCT04488601 | Completed Phase 2 FDA Drug

• 1 other identifier: ALRx001
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

rapamycin; aging; longevity; sirolimus; healthy aging; age-related conditions

Outcome Measures

Primary Outcomes (1)

• Changes in visceral fat as measured by dual-energy x-ray absorptiometry (DXA) scan

  Visceral fat changes from baseline as determined by DXA scan.

  6 month interim analysis of the data, 12 month safety profile will be established

Secondary Outcomes (15)

• bone density

  6 month interim analysis of the data, 12 month safety profile will be established

• lean body mass

  6 month interim analysis of the data, 12 month safety profile will be established

• adverse events

  6 month interim analysis of the data, 12 month safety profile will be established

• complete blood count (CBC)

  6 month interim analysis of the data, 12 month safety profile will be established

• 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

Study Arms (3)

Rapamycin 5

EXPERIMENTAL

Rapamycin 5 mg/week

Drug: Rapamycin

Rapamycin 10

EXPERIMENTAL

Rapamycin 10 mg/week

Drug: Rapamycin

Placebo 1

PLACEBO COMPARATOR

Placebo once per week

Drug: Placebo

Interventions

Rapamycin DRUG

Rapamycin in 2 different dosage forms.

Also known as: Sirolimus, Rapamune, Rapacan, Siromus, Raparen, Rapasim, Sirova

Rapamycin 10; Rapamycin 5

Placebo DRUG

Placebo capsules

Placebo 1

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• AgelessRx: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

AgelessRx

Chicago, Illinois, 60605, United States

Location

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• James Watson, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Sajad Zalzala, MD

  AgelessRx

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, Double-Blind, Placebo-Controlled Trial

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 28, 2020
• Study Start: January 1, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 24, 2024

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: as soon as available
• Access Criteria: Institutional review board (IRB) approval or at the discretion of PI/sponsor

Locations

US (1)