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Trial · Interventional

Active, not recruitingPhase 3Registry data

Combination Gerotherapeutic Interventions for Healthspan Improvement

NCTNCT07475546 (opens ClinicalTrials.gov in a new tab)Other idALRx011
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 3
Enrollment
30 participants (estimated)
Sponsor
AgelessRx · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
23 Jul 2025
Primary completion
Apr 2026 (estimated)
Completion
Apr 2026 (estimated)
First posted
16 Mar 2026
Last update posted
16 Mar 2026
Conditions
Healthspan Improvement · Aging · Longevity

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202520262027
  1. Ph 3

    Combination Gerotherapeutic Interventions for Healthspan Improvement

    NCT07475546

    23 Jul 2025 to est. Apr 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • RapamycinDrug
  • NaltrexoneDrug
  • MetforminDrug
  • NAD+Drug
  • GSHDrug
  • Infinite SupplementDietary supplement
  • Placebo/controlDrug
  • B12Dietary supplement
  • Intervention: Guided Meditation ProgramBehavioral
  • Control: Podcast Listening ActivityBehavioral
  • Control: Standard Exercise RegimenBehavioral
  • Intervention: Structured Exercise ProgramBehavioral

Arms3

  • 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 outcomes4

Outcomes the sponsor listed as primary.

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

    Time frame · 3 months

    Registry description

    Maximal oxygen uptake (VO₂ max) will be assessed using standardized cardiopulmonary exercise testing. This assessment will be conducted once at baseline and once at the 3-month follow-up. The outcome will be the change in VO₂ max from baseline to 3 months.

  2. Change in cognitive performance measured by Creyos Cognitive Test composite score

    Time frame · 3 months

    Registry description

    Cognitive performance will be assessed using the Creyos online cognitive assessment platform. Assessments will be conducted twice at baseline and twice during the final study period, with measurements occurring at least 7 days apart. Scores from the two assessments at each timepoint will be averaged to determine the baseline and endpoint values. The outcome will be the change in the overall composite cognitive performance score from baseline to 3 months.

  3. Change in systemic chronic inflammation measured by iAge index score

    Time frame · 3 months

    Registry description

    Immune function will be assessed via systemic chronic inflammation using the iAge Index Score derived from blood biomarkers. This assessment will be conducted once at baseline and once at the 3-month follow-up. The outcome will be the change in iAge index score from baseline to 3 months.

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

    Time frame · 3 months

    Registry description

    Lean body mass will be assessed using dual-energy X-ray absorptiometry (DEXA). This assessment will be conducted once at baseline and once at the 3-month follow-up. The outcome will be the change in total lean body mass from baseline to 3 months.

Secondary outcomes(15)

  1. Change in total sleep time measured using Oura wearable device

    Time frame · 3 months

    Registry description

    Total sleep time will be assessed using sleep data collected from the Oura Ring wearable device. Total sleep time represents the total duration of sleep obtained during the primary sleep period each night. Total sleep time will be measured twice at baseline and twice during the final study period, with measurements occurring at least 7 days apart. Values from each assessment period will be averaged to determine the baseline and 3-month outcome values. The outcome will be the change in average nightly total sleep time from baseline to 3 months.

  2. Change in health-related quality of life measured by the Short Form Health Survey (SF-36)

    Time frame · 3 months

    Registry description

    Quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). Scores range from 0 to 100, with higher scores indicating better health-related quality of life. Assessments will be conducted twice at baseline and twice at the 3-month follow-up, with measurements occurring at least 7 days apart. Values from the two assessments at each timepoint will be averaged. The outcome will be the change in overall SF-36 score from baseline to 3 months.

  3. Change in biological age estimated from blood-based biomarker panels

    Time frame · 3 months

    Registry description

    Biological age will be estimated using biomarker panels derived from the iollo home testing kit. his assessment will be conducted once at baseline and once at the 3-month follow-up. The outcome will be the change in estimated biological age from baseline to 3 months.

  4. Change in sleep quality measured by the Sleep Quality Scale (SQS)

    Time frame · 3 months

    Registry description

    Sleep quality will be assessed using the Sleep Quality Scale (SQS), a validated self-report instrument ranging from 0 to 84, where higher scores indicate worse sleep quality. Assessments will be conducted twice at baseline and twice at the 3-month follow-up, with measurements occurring at least 7 days apart. Values from the two assessments at each timepoint will be averaged. The outcome will be the change in overall sleep score from baseline to 3 months.

  5. Change in physical activity measured by the Rapid Assessment of Physical Activity (RAPA) questionnaire

    Time frame · 3 months

    Registry description

    Physical activity will be assessed using the Rapid Assessment of Physical Activity (RAPA) questionnaire. Scores range from 1 to 7, with higher scores indicating greater levels of physical activity. Assessments will be conducted twice at baseline and twice at the 3-month follow-up, with measurements occurring at least 7 days apart. Values from the two assessments at each timepoint will be averaged. The outcome will be the change in physical activity score from baseline to 3 months.

  6. Change in self-reported immune function measured by the Immune Status Questionnaire (ISQ)

    Time frame · 3 months

    Registry description

    Self-reported immune function will be assessed using the Immune Status Questionnaire (ISQ), a validated self-report instrument that evaluates the frequency of immune-related symptoms (e.g., colds, fever, cough, and other infection-related complaints). The ISQ produces a total score ranging from 0 to 10, with higher scores indicating better perceived immune functioning. Assessments will be conducted twice at baseline and twice at the 3-month follow-up, with measurements occurring at least 7 days apart. Values from the two assessments at each timepoint will be averaged. The outcome will be the change in ISQ total score from baseline to 3 months.

  7. Change from baseline to 3 months in hemoglobin A1c

    Time frame · 3 months

    Registry description

    Hemoglobin A1c (HbA1c) will be measured from venous blood samples collected during routine laboratory testing. HbA1c reflects average blood glucose levels over approximately the prior 2-3 months. Blood samples will be collected twice at baseline and twice during the final study period with assessments occurring at least 7 days apart. Values from each timepoint will be averaged.

  8. Change from baseline to 3 months in fasting insulin concentration

    Time frame · 3 months

    Registry description

    Fasting insulin will be measured from venous blood samples collected during routine laboratory testing. Blood samples will be collected twice at baseline and twice during the final study period with assessments occurring at least 7 days apart. Measurements from each timepoint will be averaged.

  9. Change from baseline to 3 months in high-sensitivity C-reactive protein (hs-CRP)

    Time frame · 3 months

    Registry description

    High-sensitivity C-reactive protein (hs-CRP) will be measured from venous blood samples as a marker of systemic inflammation. Blood samples will be collected twice at baseline and twice during the final study period with assessments occurring at least 7 days apart. Measurements from each timepoint will be averaged.

  10. Change from baseline to 3 months in low-density lipoprotein cholesterol (LDL-C)

    Time frame · 3 months

    Registry description

    Low-density lipoprotein cholesterol will be measured from fasting venous blood samples as part of a lipid panel. Blood samples will be collected twice at baseline and twice during the final study period with assessments occurring at least 7 days apart. Measurements from each timepoint will be averaged.

  11. Change from baseline to 3 months in high-density lipoprotein cholesterol (HDL-C)

    Time frame · 3 months

    Registry description

    High-density lipoprotein cholesterol will be measured from fasting venous blood samples as part of a lipid panel. Blood samples will be collected twice at baseline and twice during the final study period with assessments occurring at least 7 days apart. Measurements from each timepoint will be averaged.

  12. Change from baseline to 3 months in fasting triglyceride levels

    Time frame · 3 months

    Registry description

    Triglycerides will be measured from fasting venous blood samples as part of a lipid panel. Blood samples will be collected twice at baseline and twice during the final study period with assessments occurring at least 7 days apart. Measurements from each timepoint will be averaged.

  13. Change from baseline to 3 months in fasting plasma glucose

    Time frame · 3 months

    Registry description

    Fasting glucose will be measured from venous blood samples collected during routine laboratory testing. Blood samples will be collected twice at baseline and twice during the final study period with assessments occurring at least 7 days apart. Measurements from each timepoint will be averaged.

  14. Change from baseline to 3 months in creatinine

    Time frame · 3 months

    Registry description

    Creatinine will be measured from venous blood samples as part of a comprehensive metabolic panel to assess kidney function. Blood samples will be collected twice at baseline and twice during the final study period with assessments occurring at least 7 days apart. Measurements from each timepoint will be averaged.

  15. Change from baseline to 3 months in white blood cell count

    Time frame · 3 months

    Registry description

    White blood cell (WBC) count will be measured from venous blood samples as part of a complete blood count panel. Blood samples will be collected twice at baseline and twice during the final study period with assessments occurring at least 7 days apart. Measurements from each timepoint will be averaged.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 60 Years up to 80 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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