Actively Recruiting
A Phase 1b Clinical Trial Assessing Exercise and Spermidine with Lamivudine or Rapamycin on Inflammation and Aging
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-09-25
22
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility of an anti-aging intervention combining an exercise regimen, spermidine supplementation, and either lamivudine or rapamycin in adults aged 65 to 80 years who are current or former smokers. This Phase 1b clinical trial aims to assess safety and the impact of these interventions on systemic inflammation and aging-related changes. Participants will be randomly assigned to one of two groups: one group will perform an exercise regimen and take spermidine along with lamivudine for 180 days, while the other group will perform the same exercise regimen and take spermidine with rapamycin for 180 days. The exercise program includes high-intensity interval training twice a week and resistance training three times a week. Spermidine is given orally at 2 mg per day. During the study, researchers will monitor participants for adverse events and their ability to complete more than 80% of the pharmacological intervention. They will also measure inflammation markers like the neutrophil to lymphocyte ratio at 180 days. Safety and feasibility will be closely observed, with the total participation lasting about six months.
CONDITIONS
Brief Title
A Study of Exercise and Pharmacologic Intervention on Systemic Inflammation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 65 to 80 years
- Current or former smokers
- Body mass index (BMI) between 25 and 32
- No cancer requiring active therapy within the last 2 years
- No autoimmune disease requiring treatment with disease modifying agents
- No chronic kidney disease stage 3 or 4 or end stage renal disease
- No class 3 or 4 heart failure
You will not qualify if you...
- Cancer requiring active therapy within the last 2 years
- Autoimmune disease requiring disease modifying agents
- Receiving immune modifying biologic therapies
- Chronic kidney disease stage 3 or 4 or end stage renal disease
- History of metabolic dysfunction-associated steatohepatitis
- Chronic viral infection such as HIV or active Hepatitis B or C, or genital HSV
- Recent myocardial infarction or cerebrovascular event within past 6 months
- Uncontrolled diabetes mellitus
- History of clinically significant interstitial lung disease
- Active wound healing due to recent injury or surgery
- Signs of acute infectious illness on screening
- Evidence of active or latent tuberculosis
- Nephrotic range proteinuria on screening labs
- Received live virus vaccine within one month before study
- Uncontrolled hypertension (systolic >160 or diastolic >100)
- Inherited primary immunodeficiency
- Clinically significant chronic liver disease
- Receiving chronic immunosuppressive therapy
- Using medications that affect rapamycin blood levels or cause angioedema with rapamycin if assigned to rapamycin group (specific drugs listed in criteria)
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 180 days
Participants perform an exercise regimen and take spermidine along with either lamivudine or rapamycin for 180 days.
Exercise sessions 5 times per week and daily oral medication; visits schedule not specified
Trial Site Locations
Total: 1 location
1
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
Research Team
T
Thomas Marron, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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