A Study of Exercise and Pharmacologic Intervention on Systemic Inflammation

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Jul 1, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring whether a combination of regular exercise, a supplement called spermidine, and one of two medications (rapamycin or lamivudine) can reduce inflammation in the body, which is linked to aging and health problems. The goal is to see if this kind of anti-aging approach is possible and safe for older adults who are current or former smokers.

To join the study, participants need to be between 65 and 80 years old, have a body weight within a certain range (not too low or too high), and be either current or past smokers. People with serious health issues like recent cancer treatment, certain heart or kidney problems, uncontrolled diabetes, or infections won’t be allowed to join. If accepted, participants will follow an exercise routine, take supplements, and one of the study medications while being closely monitored for any side effects or health changes. It’s important to know that the study is not yet open for enrollment, and those interested should discuss with their healthcare provider to see if this trial might be a good fit.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients 65-80 years old
• • Current or former smokers
• • BMI 25-32
• • No cancer requiring active therapy within the last 2 years
• • No autoimmune disease requiring disease modifying agents
• • No patients with CKD stage 3/4 or ESRD
• • No class 3 or 4 heart failure
• Exclusion Criteria:
• • Patients may not have cancer requiring active therapy within the last 2 years
• • Patients may not have autoimmune disease requiring disease modifying agents
• • Patients may not be receiving immune modifying biologic therapies
• • Patients may not have chronic kidney disease stage 3/4 or end stage renal disease
• • Patients may not have a known history of metabolic dysfunction-associated steatohepatitis
• • Patients may not have a known chronic viral infection such as HIV or active Hepatitis B or C, or a known history of genital HSV. Patients who have spontaneously or through treatment cleared hepatitis B or C are candidates for the trial. If Hepatitis B core ab is positive must document a negative PCR.
• • Patients may not have class 3 or 4 heart failure, or have experienced a myocardial infarction or cerebrovascular event in the past 6 months
• • Patients may not have uncontrolled diabetes mellitus
• • Patients may not have a history of clinically significant interstitial lung disease (ILD).
• • Patients may not have clinically significant active wound healing due to recent injury or surgery
• • Patients may not have signs or symptoms of clinically significant acute infectious illness on screening laboratory testing or physical examination.
• • Patients may not have evidence of active or latent tuberculosis
• • Patients may not have nephrotic range proteinuria on screening labs
• • Patients may not have received a live virus within one month of study initiation.
• • Patients cannot have uncontrolled hypertension (persistent systolic \>160; diastolic \>100)
• • Patients with an inherited primary immunodeficiency
• • Patients may not have a history of, or current evidence of, clinically significant chronic liver disease
• • Patients may not be receiving any chronic immunosuppressive therapy.
• • Patients may not be receiving medications that could increase rapamycin blood concentrations, such as strong inhibitors and inducers of CYP3A4 and/or P-gp (ketoconazole, voriconazole, itraconazole, erythromycin, telithromycin, or clarithromycin; rifampin or rifabutin), bromocriptine, cimetidine, cisapride, clotrimazole, danazol, diltiazem, fluconazole, protease inhibitors, metoclopramide, nicardipine, troleandomycin, verapamil. Furthermore, these medications may not be used during the study if patient is assigned to the rapamycin cohort.
• • Patients may not be receiving medications that could decrease rapamycin blood concentrations, such as: carbamazepine, phenobarbital, phenytoin, rifapentine, St. John's Wort. Furthermore, these medications may not be used during the study if patient is assigned to the rapamycin cohort.
• • Patients may not be receiving medications known to cause angioedema with concomitant use of rapamycin, such as angiotensin-converting enzyme (ACE) inhibitors. Furthermore, these medications may not be used during the study if patient is assigned to the rapamycin cohort.