Combination Gerotherapeutic Interventions for Healthspan Improvement

AgelessRx

Status and phase

Active, not recruiting

Phase 3

Conditions

Aging

Longevity

Healthspan Improvement

Treatments

Drug: NAD+

Dietary Supplement: Infinite Supplement

Drug: GSH

Behavioral: Intervention: Guided Meditation Program

Dietary Supplement: B12

Drug: Rapamycin

Drug: Metformin

Drug: Naltrexone

Drug: Placebo/control

Behavioral: Control: Podcast Listening Activity

Behavioral: Intervention: Structured Exercise Program

Behavioral: Control: Standard Exercise Regimen

Study type

Interventional

Funder types

Industry

Identifiers

NCT07475546

ALRx011

Details and patient eligibility

About

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).

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

60 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 3 patient groups, including a placebo group

Multi-Therapy: NAD+, LDN, B12, and metformin

Experimental group

Description:

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.

Treatment:

Drug: Metformin

Behavioral: Intervention: Guided Meditation Program

Dietary Supplement: B12

Behavioral: Intervention: Structured Exercise Program

Drug: NAD+

Drug: Naltrexone

Comprehensive Therapy: LDR, LDN, B12, metformin, NAD+, GSH, and Infinite

Experimental group

Description:

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.

Treatment:

Drug: Metformin

Behavioral: Intervention: Guided Meditation Program

Dietary Supplement: B12

Drug: Rapamycin

Behavioral: Intervention: Structured Exercise Program

Drug: GSH

Dietary Supplement: Infinite Supplement

Drug: NAD+

Drug: Naltrexone

Placebo

Placebo Comparator group