Combination Gerotherapeutic Interventions for Healthspan Improvement

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).

Conditions

• Healthspan Improvement
• Aging
• Longevity

Interventions

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.

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).

Sponsors & Collaborators

• AgelessRx

  lead INDUSTRY

Principal Investigators

• Jenell Decker, MD · AgelessRx

• Stefanie Morgan, PhD · AgelessRx

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-07-23

Primary Completion

2026-04-30

Completion

2026-04-30

FDA Drug

Yes

Countries

• United States

Study Locations