Anti-Aging cocktail tested in older smokers
NCT ID NCT07058974
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times
Summary
This early-stage study tests whether combining exercise, a natural supplement called spermidine, and either rapamycin or lamivudine is safe and doable for current or former smokers aged 65-80. The goal is to see if this mix can reduce inflammation and slow aging. Only 22 participants will be enrolled, and the main focus is on safety and whether people can stick with the program.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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20 people
The number who actually took part.
- Started
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Aug 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients 60-85 years old * Current or former smokers * BMI 25-35 * No cancer requiring active therapy within the last 2 years * No autoimmune disease requiring disease modifying agents * No patients with EGFR \<30 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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Mount Sinai Hospital
New York, New York, 10029, United States
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Other studies related to the condition(s) this trial covers.
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