Combination Gerotherapeutic Interventions for Healthspan Improvement

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
AgelessRx
Study ID
NCT07475546
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Aging
  • Healthspan Improvement
  • Longevity

Eligibility Criteria

Sex
ALL
Age
60 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Rapamycin — DRUG
    In the comprehensive therapy group, participants will start LDR at 2mg once per week and titrate up weekly to 6mg once per week.
  • Naltrexone — DRUG
    In both intervention groups, participants will start LDN at 1.5mg once daily and titrate up each week to 4.5mg daily.
  • Metformin — DRUG
    In both intervention groups, participants will take Metformin at 500mg daily.
  • NAD+ — DRUG
    In both intervention groups, NAD+ will be taken as a nasal spray of 30mg/day.
  • GSH — DRUG
    In the comprehensive therapy group, GSH will be taken as a topical patch for 4 hrs, once per week.
  • Infinite Supplement — DIETARY_SUPPLEMENT
    Participants in the comprehensive therapy group will take the Infinite supplement once daily. The Infinite supplement is a proprietary blend of seven putative geroprotective compounds implicated in enhancing cellular function critical for managing cellular damage accumulation prevention of age-related decline (including Alpha ketoglutarate, Quercetin, Glucosamine, Carnosine, Pterostilbene, Astaxanthin, and Curcumin)
  • Placebo/control — DRUG
    In the control cohort, participants will take Vitamin C (1x/day) and Vitamin E (1x/week) as placebo agents.
  • B12 — DIETARY_SUPPLEMENT
    In both intervention groups, participants will take vitamin B12 once daily.
  • Intervention: Guided Meditation Program — BEHAVIORAL
    Intervention group participants will follow a daily, app-based meditation program for 20 minutes a day.
  • Control: Podcast Listening Activity — BEHAVIORAL
    Control participants will listen to a neutral podcast for 20 minutes a day designed to control for time and attention.
  • Control: Standard Exercise Regimen — BEHAVIORAL
    Control group participants will engage in a standard exercise regimen (150 minutes of aerobic activity such as walking per week).
  • Intervention: Structured Exercise Program — BEHAVIORAL
    Intervention group participants will follow a structured daily exercise program including resistance training and a recommendation for 150 minutes of aerobic activity (e.g., walking) per week.

Study Details

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).

Key Dates

Start date
Jul 23, 2025
Status verified
Mar 2026
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Multi-Therapy: NAD+, LDN, B12, and metformin
    In intervention month one, participants naive to all medications will be titrated on to low maintenance doses of each. NAD+ will be taken as a nasal spray of 30mg/day; LDN, will start at 1.5mg once daily and titrate up each week to 4.5mg daily; B12, take 1 cap per day (100mcg); Metformin will be taken 500mg daily. They will then remain on the maintenance doses of the combination therapy for the next 60 days.
  • Experimental: Comprehensive Therapy: LDR, LDN, B12, metformin, NAD+, GSH, and Infinite
    In intervention month one, participants naive to all medications will be titrated on to low maintenance doses of each. LDR will start at 2mg once per week and titrate up weekly to 6mg once per week; LDN, will start at 1.5mg once daily and titrate up each week to 4.5mg daily; B12, take 1 cap per day (100mcg); Metformin will be taken 500mg daily; NAD+ will be taken as a nasal spray of 30mg/day; GSH will be taken as a topical patch for 4 hrs, once per week; Infinite supplement will be taken once daily. They will then remain on the maintenance doses of the combination therapy for the next 60 days.
  • Placebo Comparator: Placebo
    In the control cohort, participants will take Vitamin C (1x/day) and Vitamin E (1x/week) as placebo agents.

Primary Outcome Measure

Change in cardiorespiratory fitness measured by maximal oxygen uptake (VO₂ max) [ Time Frame: 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
AgelessRxAnn ArborMichigan48104-

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