Phase 2 N=34 Randomized Quadruple-blind Basic Science

Effect of mTOR Inhibition and Other Metabolism Modulating Interventions on the Elderly

Aging

Bottom Line

View on ClinicalTrials.gov: NCT02874924 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2018

Primary outcome: Primary: Immunological Responses — 8.33; 11.24 cells/mm^3 — p=0.56

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Rapamycin (Drug); Placebo (Drug)
Age: Older Adult · 70+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center at San Antonio
Primary completion: Sep 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Immunological Responses	8.33; 11.24	0.56
SECONDARY Physical Performance	7.75; 7.17	—
SECONDARY Cognitive Function	7.2; 6.92	—

Summary

The ability to mount an effective immune response declines with age, leaving the elderly increasingly susceptible to infectious diseases and cancer. Rapamycin, an FDA approved drug to prevent transplant rejection, increases the lifespan and healthspan of mice and ameliorates age-related declines in immune responsiveness, cancer survival, and cognition in laboratory animals. Investigators are conducting a translational trial to test whether rapamycin also improves life functions in humans focusing on elderly persons (aged 70-95).

Eligibility Criteria

Inclusion Criteria: age 70-95

participants will be in good health with all chronic diseases (hypertension, coronary artery disease, etc.) clinically stable.
participants must have adequate cognitive function to be able to give informed consent. This will be established by enrolling participants with CLOX 1 scores of ≥10.

Exclusion Criteria

unstable ischemic heart disease
clinically significant pulmonary disease
history of immunodeficiency or receiving immunosuppressive therapy
history of a coagulopathy or receiving a medical condition requiring anticoagulation
an estimated glomerular filtration rate of 350mg/dl;
uncontrolled hypertriglyceridemia >500mg/dl
diabetes
history of skin ulcers or poor wound healing
smoking
liver disease
treatment with drugs known to affect cytochrome P450 3A (diltiazem, erythromycin)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02874924). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.