Healthspan ImprovementPhase 3NCT07475546
Combination Gerotherapeutic Interventions for Healthspan Improvement
A Phase 3 study testing Rapamycin, Naltrexone and Metformin in people with Healthspan Improvement and Aging, run by AgelessRx at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthspan Improvement, Aging, Longevity
- What is being tested?
- Rapamycin, Naltrexone and Metformin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2025to 9 Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomized Controlled Study of Combinatorial Gerotherapeutics for Healthspan Improvement
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 3) Comprehensive Therapy (Rapamycin, Naltrexone, Metformin, B12, NAD+, GSH, and Infinite Supplement).
Read the 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 lean mass and VO2 max, assessed by a formal test and/or Oura ring estimate), cognitive function (by Creyos cognitive tests via web browser), immune function (by iAge and the Immune Status Questionnaire [ISQ]), quality of life (SF-36), biological age (PhenoAge, calculated from nine biomarkers in the routine blood work), activity levels (RAPA questionnaire and Oura ring), metabolic and safety health measures, and sleep (Oura ring sleep duration and the Sleep Quality Scale [SQS]), as well as other health indicators from Oura wearable data. Routine blood work will include a comprehensive metabolic panel, complete blood count with differential and platelets, hemoglobin A1c, fasting insulin, high-sensitivity C-reactive protein (hs-CRP), and a lipid panel. Metabolic health will also be assessed with at-home blood testing kits (Iollo). To ensure robustness of outcome measures, two measurements of each item approximately one week apart will be used at baseline and again at study end for the questionnaires, cognitive tests and routine blood work. Oura measures will be averaged across a two-week period at each timepoint. DEXA, VO2 max testing (formal test or Oura estimate), iAge and Iollo kits will each be used once at baseline and once at study end.
- Conditions
- Healthspan Improvement, Aging, Longevity
- Being tested
- Rapamycin, Naltrexone, Metformin, NAD+, GSH
- Keywords
- Gerotherapeutics, Rapamycin, Naltrexone, Metformin, NAD+, GSH, B12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RapamycinDrug
Also called sirolimus, low-dose rapamycin (LDR)
In the comprehensive therapy group, participants will start LDR at 2mg once per week and titrate up weekly to 6mg once per week.
NaltrexoneDrug
Also called low-dose naltrexone (LDN)
In both intervention groups, participants will start LDN at 1.5mg once daily and titrate up each week to 4.5mg daily.
MetforminDrug
In both intervention groups, participants will take Metformin at 500mg daily.
NAD+Drug
Also called nicotinamide adenine dinucleotide (NAD+)
In both intervention groups, NAD+ will be taken as a nasal spray of 30mg/day.
GSHDrug
Also called Glutathione
In the comprehensive therapy group, GSH will be taken as a topical patch for 4 hrs, once per week.
Infinite SupplementDietary 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/controlDrug
In the control cohort, participants will take Vitamin C (1x/day) and Vitamin E (1x/week) as placebo agents.
B12Dietary supplement
Also called Methylcobalamin
In both intervention groups, participants will take vitamin B12 once daily.
Intervention: Guided Meditation ProgramBehavioural
Intervention group participants will follow a daily, app-based meditation program for 20 minutes a day.
Control: Podcast Listening ActivityBehavioural
Control participants will listen to a neutral podcast for 20 minutes a day designed to control for time and attention.
Control: Standard Exercise RegimenBehavioural
Control group participants will engage in a standard exercise regimen (150 minutes of aerobic activity such as walking per week).
Intervention: Structured Exercise ProgramBehavioural
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 group | Role | What they receive |
|---|---|---|
| Multi-Therapy: NAD+, LDN, B12, and metformin | Experimental | 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. Receives: Drug: Naltrexone; Drug: Metformin; Drug: NAD+; Dietary Supplement: B12; Behavioral: Intervention: Guided Meditation Program; Behavioral: Intervention: Structured Exercise Program |
| Comprehensive Therapy: LDR, LDN, B12, metformin, NAD+, GSH, and Infinite | Experimental | 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. Receives: Drug: Rapamycin; Drug: Naltrexone; Drug: Metformin; Drug: NAD+; Drug: GSH; Dietary Supplement: Infinite Supplement; Dietary Supplement: B12; Behavioral: Intervention: Guided Meditation Program; Behavioral: Intervention: Structured Exercise Program |
| Placebo | Placebo comparator | In the control cohort, participants will take Vitamin C (1x/day) and Vitamin E (1x/week) as placebo agents. Receives: Drug: Placebo/control; Behavioral: Control: Podcast Listening Activity; Behavioral: Control: Standard Exercise Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiorespiratory fitness measured by maximal oxygen uptake (VO₂ max)
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.
Measured: 3 months
Change in cognitive performance measured by Creyos Cognitive Test
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, approximately one week apart. Raw task scores will be used for Token Search, Feature Match, and Double Trouble. Raw scores are on different scales: Token Search is the mean number of items across successfully completed problems, and Feature Match and Double Trouble are net-correct scores (points or problems answered correctly minus those answered incorrectly). Scores from the two assessments at each timepoint will be averaged. Higher scores indicate better cognitive performance. The outcome is the change in raw scores from baseline to 3 months (positive change = improvement).
Measured: 3 months
Change in systemic chronic inflammation measured by iAge index score
Immune function will be assessed via systemic chronic inflammation using the Inflammatory Age (iAge®) test (Edifice Health), derived from circulating immune proteins in blood. Assessments will be conducted once at baseline and once at the 3-month follow-up. Two iAge outputs will be reported:
- iAge in years, an estimate of inflammatory (immune) age. It has no fixed minimum or maximum. Lower values indicate a biologically younger immune profile and lower systemic chronic inflammation (better outcome); higher values indicate a biologically older immune profile (worse outcome).
- iAge index score, a unitless score with no fixed minimum or maximum. Edifice Health defines a typical range of 2.5 to 7.5. Lower scores indicate lower systemic chronic inflammation (better outcome); higher scores indicate greater inflammation (worse outcome). The outcome is the change in each measure from baseline to 3 months.
Negative change indicates improvement for both.
Measured: 3 months
Change in lean body mass measured by dual-energy X-ray absorptiometry (DEXA)
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.
Measured: 3 months
Secondary outcomes (15)
Change in total sleep time measured using Oura wearable device
Total sleep time will be assessed using sleep data collected by the Oura Ring, defined as the total duration of sleep during the primary overnight sleep period. Nightly values will be averaged across a two-week period at baseline and across a two-week period at 3 months. Total sleep time is reported in seconds per night (converted to hours for presentation) and has no fixed minimum or maximum. Longer sleep duration is generally considered better. The outcome is the change in mean nightly total sleep time from baseline to 3 months (positive change = more sleep).
Measured: 3 months
Change in health-related quality of life measured by the Short Form Health Survey (SF-36)
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.
Measured: 3 months
Change in biological age (PhenoAge) estimated from routine blood biomarkers
Biological age will be estimated using PhenoAge, calculated from nine routine clinical blood biomarkers: albumin, creatinine, fasting glucose, C-reactive protein, lymphocyte percentage, mean corpuscular volume, red cell distribution width, alkaline phosphatase, and white blood cell count. Blood samples will be collected at baseline and at the 3-month follow-up. PhenoAge is expressed in years and has no fixed minimum or maximum. Lower values indicate a biologically younger profile (better outcome); higher values indicate a biologically older profile (worse outcome). The outcome is the change in PhenoAge from baseline to 3 months (negative change = improvement).
Measured: 3 months
Change in sleep quality measured by the Sleep Quality Scale (SQS)
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.
Measured: 3 months
Change in physical activity measured by the Rapid Assessment of Physical Activity (RAPA) questionnaire
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.
Measured: 3 months
Change in self-reported immune function measured by the Immune Status Questionnaire (ISQ)
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.
Measured: 3 months
Change from baseline to 3 months in hemoglobin A1c
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.
Measured: 3 months
Change from baseline to 3 months in fasting insulin concentration
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.
Measured: 3 months
Change from baseline to 3 months in high-sensitivity C-reactive protein (hs-CRP)
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.
Measured: 3 months
Change from baseline to 3 months in low-density lipoprotein cholesterol (LDL-C)
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.
Measured: 3 months
Change from baseline to 3 months in high-density lipoprotein cholesterol (HDL-C)
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.
Measured: 3 months
Change from baseline to 3 months in fasting triglyceride levels
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.
Measured: 3 months
Change from baseline to 3 months in fasting plasma glucose
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.
Measured: 3 months
Change from baseline to 3 months in creatinine
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.
Measured: 3 months
Change from baseline to 3 months in white blood cell count
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start23 Jul 2025
- Primary completion9 Apr 2026
- Study completion9 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthspan ImprovementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- AgelessRx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jenell Decker, MD, Principal investigator, AgelessRxStefanie Morgan, PhD, Principal investigator, AgelessRx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475546
- Sponsor's protocol ID
- ALRx011
- Status last verified
- Mar 2026
- First submitted
- 2 Feb 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Study of Combinatorial Gerotherapeutics for Healthspan Improvement
- ClinicalTrials.gov ID
- NCT07475546
- Acronym / sponsor ID
- ALRx011
- Conditions
- Healthspan Improvement, Aging, Longevity
- Keywords
- Gerotherapeutics, Rapamycin, Naltrexone, Metformin, NAD+, GSH, B12
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- AgelessRxIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- 9 Apr 2026 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 3) 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 lean mass and VO2 max, assessed by a formal test and/or Oura ring estimate), cognitive function (by Creyos cognitive tests via web browser), immune function (by iAge and the Immune Status Questionnaire [ISQ]), quality of life (SF-36), biological age (PhenoAge, calculated from nine biomarkers in the routine blood work), activity levels (RAPA questionnaire and Oura ring), metabolic and safety health measures, and sleep (Oura ring sleep duration and the Sleep Quality Scale [SQS]), as well as other health indicators from Oura wearable data. Routine blood work will include a comprehensive metabolic panel, complete blood count with differential and platelets, hemoglobin A1c, fasting insulin, high-sensitivity C-reactive protein (hs-CRP), and a lipid panel. Metabolic health will also be assessed with at-home blood testing kits (Iollo). To ensure robustness of outcome measures, two measurements of each item approximately one week apart will be used at baseline and again at study end for the questionnaires, cognitive tests and routine blood work. Oura measures will be averaged across a two-week period at each timepoint. DEXA, VO2 max testing (formal test or Oura estimate), iAge and Iollo kits will each be used once at baseline and once at study end.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multi-Therapy: NAD+, LDN, B12, and metformin | Experimental | Drug: Naltrexone, Drug: Metformin, Drug: NAD+, Dietary Supplement: B12, Behavioral: Intervention: Guided Meditation Program, Behavioral: Intervention: Structured Exercise ProgramIn 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. |
| Comprehensive Therapy: LDR, LDN, B12, metformin, NAD+, GSH, and Infinite | Experimental | Drug: Rapamycin, Drug: Naltrexone, Drug: Metformin, Drug: NAD+, Drug: GSH, Dietary Supplement: Infinite Supplement, Dietary Supplement: B12, Behavioral: Intervention: Guided Meditation Program, Behavioral: Intervention: Structured Exercise ProgramIn 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 | Placebo comparator | Drug: Placebo/control, Behavioral: Control: Podcast Listening Activity, Behavioral: Control: Standard Exercise RegimenIn the control cohort, participants will take Vitamin C (1x/day) and Vitamin E (1x/week) as placebo agents. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RapamycinAlso: sirolimus, low-dose rapamycin (LDR)In the comprehensive therapy group, participants will start LDR at 2mg once per week and titrate up weekly to 6mg once per week. | Drug | Comprehensive Therapy: LDR, LDN, B12, metformin, NAD+, GSH, and Infinite |
| NaltrexoneAlso: low-dose naltrexone (LDN)In both intervention groups, participants will start LDN at 1.5mg once daily and titrate up each week to 4.5mg daily. | Drug | Comprehensive Therapy: LDR, LDN, B12, metformin, NAD+, GSH, and Infinite, Multi-Therapy: NAD+, LDN, B12, and metformin |
| MetforminIn both intervention groups, participants will take Metformin at 500mg daily. | Drug | Comprehensive Therapy: LDR, LDN, B12, metformin, NAD+, GSH, and Infinite, Multi-Therapy: NAD+, LDN, B12, and metformin |
| NAD+Also: nicotinamide adenine dinucleotide (NAD+)In both intervention groups, NAD+ will be taken as a nasal spray of 30mg/day. | Drug | Comprehensive Therapy: LDR, LDN, B12, metformin, NAD+, GSH, and Infinite, Multi-Therapy: NAD+, LDN, B12, and metformin |
| GSHAlso: GlutathioneIn the comprehensive therapy group, GSH will be taken as a topical patch for 4 hrs, once per week. | Drug | Comprehensive Therapy: LDR, LDN, B12, metformin, NAD+, GSH, and Infinite |
| Infinite SupplementParticipants 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) | Dietary supplement | Comprehensive Therapy: LDR, LDN, B12, metformin, NAD+, GSH, and Infinite |
| Placebo/controlIn the control cohort, participants will take Vitamin C (1x/day) and Vitamin E (1x/week) as placebo agents. | Drug | Placebo |
| B12Also: MethylcobalaminIn both intervention groups, participants will take vitamin B12 once daily. | Dietary supplement | Comprehensive Therapy: LDR, LDN, B12, metformin, NAD+, GSH, and Infinite, Multi-Therapy: NAD+, LDN, B12, and metformin |
| Intervention: Guided Meditation ProgramIntervention group participants will follow a daily, app-based meditation program for 20 minutes a day. | Behavioural | Comprehensive Therapy: LDR, LDN, B12, metformin, NAD+, GSH, and Infinite, Multi-Therapy: NAD+, LDN, B12, and metformin |
| Control: Podcast Listening ActivityControl participants will listen to a neutral podcast for 20 minutes a day designed to control for time and attention. | Behavioural | Placebo |
| Control: Standard Exercise RegimenControl group participants will engage in a standard exercise regimen (150 minutes of aerobic activity such as walking per week). | Behavioural | Placebo |
| Intervention: Structured Exercise ProgramIntervention 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. | Behavioural | Comprehensive Therapy: LDR, LDN, B12, metformin, NAD+, GSH, and Infinite, Multi-Therapy: NAD+, LDN, B12, and metformin |
Primary outcome
Change in cardiorespiratory fitness measured by maximal oxygen uptake (VO₂ max)
Time frame: 3 months
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.
Change in cognitive performance measured by Creyos Cognitive Test
Time frame: 3 months
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, approximately one week apart. Raw task scores will be used for Token Search, Feature Match, and Double Trouble. Raw scores are on different scales: Token Search is the mean number of items across successfully completed problems, and Feature Match and Double Trouble are net-correct scores (points or problems answered correctly minus those answered incorrectly). Scores from the two assessments at each timepoint will be averaged. Higher scores indicate better cognitive performance. The outcome is the change in raw scores from baseline to 3 months (positive change = improvement).
Change in systemic chronic inflammation measured by iAge index score
Time frame: 3 months
Immune function will be assessed via systemic chronic inflammation using the Inflammatory Age (iAge®) test (Edifice Health), derived from circulating immune proteins in blood. Assessments will be conducted once at baseline and once at the 3-month follow-up. Two iAge outputs will be reported: 1. iAge in years, an estimate of inflammatory (immune) age. It has no fixed minimum or maximum. Lower values indicate a biologically younger immune profile and lower systemic chronic inflammation (better outcome); higher values indicate a biologically older immune profile (worse outcome). 2. iAge index score, a unitless score with no fixed minimum or maximum. Edifice Health defines a typical range of 2.5 to 7.5. Lower scores indicate lower systemic chronic inflammation (better outcome); higher scores indicate greater inflammation (worse outcome). The outcome is the change in each measure from baseline to 3 months. Negative change indicates improvement for both.
Change in lean body mass measured by dual-energy X-ray absorptiometry (DEXA)
Time frame: 3 months
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.
15 secondary outcomes
Change in total sleep time measured using Oura wearable device
Time frame: 3 months
Change in health-related quality of life measured by the Short Form Health Survey (SF-36)
Time frame: 3 months
Change in biological age (PhenoAge) estimated from routine blood biomarkers
Time frame: 3 months
Change in sleep quality measured by the Sleep Quality Scale (SQS)
Time frame: 3 months
Change in physical activity measured by the Rapid Assessment of Physical Activity (RAPA) questionnaire
Time frame: 3 months
Change in self-reported immune function measured by the Immune Status Questionnaire (ISQ)
Time frame: 3 months
Change from baseline to 3 months in hemoglobin A1c
Time frame: 3 months
Change from baseline to 3 months in fasting insulin concentration
Time frame: 3 months
Change from baseline to 3 months in high-sensitivity C-reactive protein (hs-CRP)
Time frame: 3 months
Change from baseline to 3 months in low-density lipoprotein cholesterol (LDL-C)
Time frame: 3 months
Change from baseline to 3 months in high-density lipoprotein cholesterol (HDL-C)
Time frame: 3 months
Change from baseline to 3 months in fasting triglyceride levels
Time frame: 3 months
Change from baseline to 3 months in fasting plasma glucose
Time frame: 3 months
Change from baseline to 3 months in creatinine
Time frame: 3 months
Change from baseline to 3 months in white blood cell count
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenell Decker, MD principal investigator
AgelessRx
Stefanie Morgan, PhD principal investigator
AgelessRx
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rapamycin, Naltrexone and Metformin in people with Healthspan Improvement and Aging, run by AgelessRx at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiorespiratory fitness measured by maximal oxygen uptake (VO₂ max) (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.