NCT07475546

Combination Gerotherapeutic Interventions for Healthspan Improvement

A Pilot Randomized Controlled Study of Combinatorial Gerotherapeutics for Healthspan Improvement

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: AgelessRx · Industry
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Accepted

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).

Detailed description

The two main study objectives are 1) To evaluate the impact of different combinations of gerotherapeutics on measures of muscle, cognitive, and immune function, \& 2) To assess the impact of the combinatorial gerotherapeutics on sleep measures, perceived quality of life, and longevity biomarkers. Potential subjects will be recruited utilizing email and social media-based methods. They will be screened for eligibility and enrolled in the study upon obtaining informed consent. All groups will complete DEXA scans, V02 Max tests, Creyos cognitive assessments, Edifice Health's iAge tests, iollo at-home blood testing kits, routine blood-work, and the following standardized survey questionnaires: ISQ (Immune Status Questionnaire), SF-36 (Quality of Life), RAPA (Rapid Assessment of Physical Activity), and SQS (Sleep Quality Survey). Subjects will set up Oura data-tracking for health biometric data with study staff assistance. Intervention group participants will also receive a guided meditation program and structured exercise program to follow throughout the study. In contrast, participants in the control group will engage in a standard exercise regimen (150 minutes per week) and listen to a neutral podcast designed to control for time and attention. Participants will be evaluated at baseline and study end for measures of muscle function (by DEXA scan of muscle mass and the VO2 max test to measure endurance capacity using a formal test and/or Oura ring estimate), cognitive function (by Creyos cognitive tests via web browser), immune function (by iAge and CD4+ : CD8+ ratio/lymphocyte : neutrophil ratio with Immune Status Questionnaire (ISQ) supplementation), SF-36 Quality of Life (SF-36 QoL) survey scores, PhenoAge (from blood biomarkers obtained from routine safety labs, detailed below), activity levels (RAPA questionnaire, Oura ring), metabolic health measures from routine and at-home blood tests, sleep improvements evaluated through Oura wearable device sleep quality and quantity as well as the Sleep Quality Survey (SQS), as well as other health indicators from Oura wearable data between baseline and study end. To ensure robustness of outcome measures, two measurements of each item 1 week apart will be used at baseline and again at study end for all measures except for DEXA scan, V02 max formal test and Oura ring estimate, iAge and iollo kits, which will be used once at the beginning and once at the end of the study.

Conditions

• Healthspan Improvement
• Aging
• Longevity

Interventions

Type	Name	Description
DRUG	Rapamycin	In the comprehensive therapy group, participants will start LDR at 2mg once per week and titrate up weekly to 6mg once per week.
DRUG	Naltrexone	In both intervention groups, participants will start LDN at 1.5mg once daily and titrate up each week to 4.5mg daily.
DRUG	Metformin	In both intervention groups, participants will take Metformin at 500mg daily.
DRUG	NAD+	In both intervention groups, NAD+ will be taken as a nasal spray of 30mg/day.
DRUG	GSH	In the comprehensive therapy group, GSH will be taken as a topical patch for 4 hrs, once per week.
DIETARY_SUPPLEMENT	Infinite 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)
DRUG	Placebo/control	In the control cohort, participants will take Vitamin C (1x/day) and Vitamin E (1x/week) as placebo agents.
DIETARY_SUPPLEMENT	B12	In both intervention groups, participants will take vitamin B12 once daily.
BEHAVIORAL	Intervention: Guided Meditation Program	Intervention group participants will follow a daily, app-based meditation program for 20 minutes a day.
BEHAVIORAL	Control: Podcast Listening Activity	Control participants will listen to a neutral podcast for 20 minutes a day designed to control for time and attention.
BEHAVIORAL	Control: Standard Exercise Regimen	Control group participants will engage in a standard exercise regimen (150 minutes of aerobic activity such as walking per week).
BEHAVIORAL	Intervention: Structured Exercise Program	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.

Timeline

• Start date: 2025-07-23
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study