Active — Not RecruitingPhase 3

Combination Gerotherapeutic Interventions for Healthspan Improvement

United States30 participantsStarted 2025-07-23

Plain-language summary

This study is a 90-day interventional, randomized, controlled pilot trial exploring multi-modal gerotherapies and their impact on longevity-related outcomes. In this proof-of-concept phase, a small sample size of up to 30 subjects (10 subjects in each arm) will be randomized into one of the three arms: 1) Control, 2) Multi-therapy (B12, Naltrexone, Metformin, and NAD+), or 4) Comprehensive Therapy (Rapamycin, Naltrexone, Metformin, B12, NAD+, GSH, and Infinite Supplement).

Who can participate

Age range60 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * New, existing, or prospective AgelessRx patient * Adults (60-80 years of age) * Any sex * Any ethnicity * Willingness to provide informed consent and complete study assessments/procedures * Willingness to attend virtual meeting check-ins/follow-ups * Willingness and eligibility to take all medications used in this study * Has at-risk indicators for decline on measures of cognitive, immune, and muscle function, as indicated by a combination of BMI of 26-30; SF36 score below the validated central tendency for 2 of: physical function, physical role limitations, energy, pain; final ISQ scores of \<6; individuals that report brain fog or difficulty with mental clarity; pre-diabetic, or other comorbidities that result in reduced overall health functioning as determined by a physician Exclusion Criteria: * Pregnant or breastfeeding individuals * History of severe adverse reactions to study medications * Significant psychiatric illness that may affect participation * Determination of ineligibility for a study medication by AgelessRx medical team * Concurrent participation in other conflicting clinical trials

What they're measuring

Change in cardiorespiratory fitness measured by maximal oxygen uptake (VO₂ max)

Timeframe: 3 months

Change in cognitive performance measured by Creyos Cognitive Test composite score

Timeframe: 3 months

Change in systemic chronic inflammation measured by iAge index score

Timeframe: 3 months

Change in lean body mass measured by dual-energy X-ray absorptiometry (DEXA)

Timeframe: 3 months

Trial details

NCT IDNCT07475546

SponsorAgelessRx

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04

View on ClinicalTrials.gov More Healthspan Improvement trials

Plain-language summary

Who can participate

Age range60 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in cardiorespiratory fitness measured by maximal oxygen uptake (VO₂ max)

Timeframe: 3 months

Change in cognitive performance measured by Creyos Cognitive Test composite score

Timeframe: 3 months

Change in systemic chronic inflammation measured by iAge index score

Timeframe: 3 months

Change in lean body mass measured by dual-energy X-ray absorptiometry (DEXA)

Timeframe: 3 months