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

NCT02874924 | Completed Phase 2 Results

• 1 other identifier: HSC20120304H
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Aging

Keywords

Geriatrics

Outcome Measures

Primary Outcomes (1)

• Immunological Responses

  T cell function measured by number of T cells per millimeter cubed.

  8 weeks

Secondary Outcomes (2)

• Physical Performance

  8 weeks

• Cognitive Function

  8 weeks

Other Outcomes (2)

• Cardiovascular Effect

  8 weeks

• Volume of Diastolic Filling

  8 weeks

Study Arms (3)

Rapamycin

EXPERIMENTAL

Rapamycin 1mg taken once daily for 8 weeks

Drug: Rapamycin

Placebo

PLACEBO COMPARATOR

Placebo taken once daily for 8 weeks

Drug: Placebo

Rapamycin Alone - Cardiovascular Effects

EXPERIMENTAL

No placebo control; Rapamycin 1mg once daily for 8 weeks

Drug: Rapamycin

Interventions

Rapamycin DRUG

treatment

Also known as: Sirolimus

Rapamycin

Placebo DRUG

control

Placebo

Eligibility Criteria

• Age: 70 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \<30ml/min
• uncontrolled hypercholesteremia \>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)

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

UTHSCSA

San Antonio, Texas, 78220, United States

Location

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Dean L. Kellogg, Jr, MD, PhD
• Organization: Univ TX Health Science Center San Antonio

kelloggd@uthscsa.edu

2106175197

Study Officials

• Dean Kellogg, MD PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: August 22, 2016
• Study Start: June 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: December 4, 2018
• Results First Posted: December 4, 2018

Record last verified: 2018-03

Locations

US (1)