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Pearl: Participatory Evaluation of Aging with Rapamycin for Longevity

The first large-scale placebo-controlled clinical trial to determine the effects of Rapamycin on human longevity.

By Dr. Sajad Zalzala

Funding Successful. This project reached its goal before June 17, 2021.

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PEARL Rapamycin Lifespan Campaign Banner: Rapamycin

A Groundbreaking Clinical Trial

The medicine Rapamycin has been shown to extend the healthspan of all organisms it has been tested on – mice, worms, yeast – for decades, and yet to date there has been no trial to sufficiently demonstrate safety and proper dosing for this purpose in humans. It is now time for this to change.

With your help, we will be conducting a large clinical trial named Participatory Evaluation (of) Aging (with) Rapamycin (for) Longevity Study, or PEARL, to find out. This will be the first study to see if Rapamycin works as well in humans as it does in mice (for longevity).

Rapamycin fed late in life extends lifespan in genetically heterogeneous mice

Rapamycin was the first molecule proven to extend the lifespan of a mammal/mouse, even when given late in life (Harrison, D., Strong, R., Sharp, Z. et al. 2009). It also has the potential to treat aging related diseases (Blagosklonny, 2019) such as Alzheimer’s (Spilman P. et al. 2010) or heart disease, and not to mention, boost our immune system as well (Mannick JB. et al. 2014). It is by far the most studied longevity intervention after Calorie Restriction (CR).

Rapamycin works through the mTOR signaling pathway (Kennedy and Dudley 2016), one of the master regulators of cell metabolism and a key controller of autophagy (recycling in cells). Basically, it tells our cells to switch from growth to repair, and to clean out all the garbage. Not only that, but the quality of the proteins our cells produce increases, which means that there is less garbage in the first place. What all this amounts to is improved health and lengthened life for worms, flies and mice – now it’s our turn!

The PEARL trial will follow up to 200 participants over 12 months testing four different Rapamycin dosing regimens. It will be double-blind, randomized, placebo-controlled and registered with clinicaltrials.gov. The principal investigator is Dr. James P Watson at UCLA, who was also a PI for the famous TRIIM trial. To ensure safety the participants’ blood will be regularly monitored and side effects noted.

How Will We Know If It’s Working?

A battery of tests and measurements will be taken, both after 6 and 12 months. These will include autonomic health tests, blood tests, body composition tests, fecal microbiome testing, immune and inflammation health tests, methylation age clock testing and skeletal muscle tests.

With your help we will find out if and how well Rapamycin works to combat human aging. And, armed with a positive result, we will finally be able to help slow down onset of age related damage for you and those who you love and care about.

PEARL Rapamycin Lifespan Campaign Banner: Protocol

Interested patients will be screened for eligibility using AgelessRx‘s telemedicine platform. Eligible patients include those aged 50-85 of any sex or ethnicity, in relatively good health, and with only well-managed, clinically stable chronic diseases.

Once entered into the trial, the 200 patients will be divided into four dosing arms:

1. 2.5mg Rapamycin 3 times a week
2. 5mg Rapamycin once a week
3. 5mg Rapamycin twice a week
4. 10mg Rapamycin once a week

And a placebo control arm – vital for both scientific credibility and statistical analysis. We have carefully selected these dosing regimens, allowing for recovery each week and with the total dose would not exceeding the regular dose of Rapamycin used in renal transplant patients (current FDA-approved regimen).

The safety of the participants is of paramount importance, so, apart from watching out for any side effects, their blood will be monitored by looking at CBC, electrolytes, lipids, liver and renal function.

The following tests will be conducted for evaluating efficacy:

1. Autonomic health tests – including baseline (am) heart rate and baseline (am) heart rate variability testing.
2. Blood tests – Standard measures of risk of age-associated diseases (glucoregulatory markers, lipids), and markers of inflammation.
3. Body composition testing with DXA scans – measuring bone density as well as visceral fat content.
4. Fecal Microbiome testing.
5. Immune Health Tests – including CD4/CD8 ratio, CMV IgG, TNFΙ‘, hsCRP, and IL-6.
6. Methylation age – clock testing (e.g. Horvath clock, GrimAge).
7. Skeletal muscle tests – including lean body mass on DXA scan.
8. Physiological data – wearable devices (steps, HRV, etc).

The results of the trial will be published in an open access peer reviewed scientific journal.
In addition the data generated in the trial will be made available to any party.

PEARL Rapamycin Lifespan Campaign Banner: Budget

PEARL_Budget_PieChart

The most significant parts of our budget reflect the costs of performing of tests described in the PEARL protocol above β€” lab tests such as metabolic panels and insulin level analysis, and other tests such as microbiome and epigenetic clock biomarker testing β€” with the the remainder being allocated to sourcing the required amounts of Rapamycin and trial administration. While we’ve been able to mitigate costs thanks to the generous collaboration of Dr. Mikhail Blagosklonny at Roswell Park Comprehensive Cancer Center, James Clement at Better Humans, Adam Kadela at DexaFit, TruDiagnostic, GERO.ai, Mayo Clinic Translational Geroscience Network, Young.ai, and many others, it is still prohibitively expensive to run such a study with 200 participants. It is only thanks to the additional support of people like you that we will together be able to launch this trial, and answer key questions about Rapamycin’s efficacy to combat aging in humans.

PEARL Rapamycin Lifespan Campaign Banner: Goals

$75,000 β€” Initial Goal
Reaching our initial campaign goal will enable us to launch the PEARL trial to examine the healthspan extending effects of Rapamycin in humans. These funds, together with the generous support of our collaborators, will allow us to enroll 200 participants in this important study and run a battery of tests at the 6 month and 12 month mark: including autonomic health tests, blood tests, immune health tests, and skeletal muscle tests, along with more specialized testing at the 12 month mark: including microbiome testing, body composition testing via DXA scans, and methylation age testing with epigenetic markers such as the Horvath clock and GrimAge.
Estimated study duration: ~12 months.
PEARL Goals - Initial Goal - PEARL Trial Launch
$120,000 β€” Stretch Goal 1
Attaining our first stretch goal will allow us to perform our entire battery of tests – including the specialized microbiome testing, body composition testing via DXA scans, and methylation age testing with epigenetic markers such as the Horvath clock and GrimAge β€” at the 6 month mark instead of only at the 12 month mark. Not only will this give us additional data points for longitudinal analysis, but will also be helpful in determining the minimal period of time Rapamycin dosing is required to see meaningful changes. All donors to this campaign at the $25 level or higher will be able to share in this process of discovery, seeing this data as soon as it becomes available.
Estimated study duration: same as initial goal.
PEARL Goals - Stretch Goal 1 - Additional Testing
$165,000 β€” Stretch Goal 2
Reaching our final stretch goal will allow us to perform an entirely new set of proteomics testing at both the 6 month and 12 month mark. This is important because protein biomarkers can provide valuable insights into age related changes (Johnson A. et al. 2020) as well provide a comprehensive picture of chronic inflammation (Furman D. et al. 2019), a driving force behind age-related deterioration – β€œinflamm-aging”. It will also allow us to study the effect on proteins associated with immune system pathways, which is particularly important given Rapamycin’s known impact on immune system function. Including these tests within PEARL will therefore allow us collectively to gain the maximum amount of information we can regarding both the efficacy and safety of Rapamycin dosing regimens.
Estimated study duration:Β  same as initial goal.
PEARL Goals - Stretch Goal 2 - Proteomics Testing
What Happens Next?

This first trial/phase is just the start.

It will be followed by a second trial/phase which will follow a larger number of participants over a longer period of time using the most effective dosing regime from the first trial/phase. It will also incorporate combinations with additional longevity drugs such as Metformin to assess any synergy with Rapamycin.

Furthermore, if this low cost and philanthropy funded trial succeeds, it will enable other longevity interventions to be tested – from generic drugs, to stem cell-based therapies, and beyond. Eventually, this will lead to the roll out of a wider variety of longevity interventions to the general public.

With your help, we can help transform the health of millions.

Thank you for your support!

PEARL Rapamycin Lifespan Campaign Banner: Team

Sajad Zalzala, M.D.
Co-Founder and Chief Medical Officer of AgelessRx
PEARL Rapamycin Lifespan Campaign Team: Sajad ZalzalaDr. Sajad Zalzala is the Co-Founder and Chief Medical Officer of AgelessRx. He combines the unique qualities of an experienced doctor passionate about disease prevention and longevity with the strategic vision and skills of a serial entrepreneur. Sajad has been passionate about slowing and reversing age-related diseases for 20 years. Sajad is one of the rare MD’s personally licensed in all 50 States, as well as Washington D.C. and Ontario. He has extensive experience working with startup companies in the telemedicine/telehealth field and has been an advisor to multiple successful healthcare startups, including Pill Club, Jack Health, forHims.
James Watson, Ph.D.
Principal Investigator of PEARL Trial
PEARL Rapamycin Lifespan Campaign Team: James WatsonDr. Watson is a board-certified Physician and co-founder of University Stem Cell Center in Santa Monica, California, where he conducted two of the first IRB-approved Phase I/II clinical trials in the US of autologous fat-derived stem cells for cosmetic and reconstructive surgery. More recently, he has successfully completed two small clinical trials in anti-aging therapies, one utilizing Rapamycin and another utilizing a triple cocktail of drugs and supplements that were shown to reverse epigenetic age in immune cells. He co-founded a biotech company, Biostrux, designed to commercialize β€œpoint-of-care”, adipose-derived stem cells with a bioresorbable scaffold to do β€œin situ” tissue engineering with autologous stem cells, work for which he has obtained three grants from the DOD and NIH. He has authored or co-authored over 30 scientific articles and book chapters, and co-authors an online blog on aging called β€œAGINGSCIENCES™, Anti-Aging Firewalls™β€ that has 85,000 regular readers worldwide. He speaks English and Thai, having grown up in Bangkok and Phuket for the first 12 years of his life.
Anar Isman, CFA
Co-Founder and CEO of AgelessRX
PEARL Rapamycin Lifespan Campaign Team: Anar IsmanAnar is Co-founder and CEO of AgelessRx. He is passionate about advancing the science of overcoming the negative effects of aging and giving everyone convenient and affordable access to the latest technologies. He has played an instrumental role in organizing the PEARL trial and establishing relationships with all collaborating partners. His hope is that this project will bring us one step closer to having a panel of β€œlongevity” biomarkers as well as open the door for more citizen-based and philanthropy funded trials.

PEARL Rapamycin Lifespan Campaign Banner: Rewards
PEARL Rapamycin Lifespan Campaign Reward: Thank You
PEARL Rapamycin Lifespan Campaign Reward: Online Data
PEARL Rapamycin Lifespan Campaign Reward: Sticker Pride Pack
PEARL Rapamycin Lifespan Campaign Reward: T-Shirt
PEARL Rapamycin Lifespan Campaign Reward: Pride Pack Combo
PEARL Rapamycin Lifespan Campaign Reward: Growing Young Book by Sergey Young
PEARL Rapamycin Lifespan Campaign Reward: Book Shirt Pride Combo
PEARL Rapamycin Lifespan Campaign Reward: Lab Coat
PEARL Rapamycin Lifespan Campaign Reward: Video Call
PEARL Rapamycin Lifespan Campaign Reward: Elena Milova Painting
PEARL Rapamycin Lifespan Campaign Reward: Testing Panel
PEARL Rapamycin Lifespan Campaign Reward: Mikhail Blagosklonny Talk
PEARL Rapamycin Lifespan Campaign Reward: Team Dinner
PEARL Rapamycin Lifespan Campaign Reward: Paper Acknowledgement
Disclaimer: Contributing to this campaign does not entitle contributor to be enrolled in the trial

Contributions to this campaign are received as donations to LEAF via Fiscal Sponsorship.

October 2021 PEARL Update

Posted on 10/14/2021 by Steve Hill

Quick PEARL Update

The Participatory Evaluation of Aging with Rapamycin for Longevity (PEARL) Trial has been a focal point for our research efforts. After successfully closing a crowdfunding campaign, raising over $180,000, we’re in the active recruiting and enrolling phase of the project. Our aim is to establish a long-term safety profile, determine the long-term efficacy of Rapamycin in reducing clinical aging measures, and biochemical and physiological endpoints associated with declining health and aging in healthy older adults.

The official PEARL protocol can be found on the U.S. National Library of Medicine’s Clinical Trials webpage here.

What’s next? We’re excited to announce that we’ve begun onboarding PEARL participants and will continue recruiting on a rolling basis. If you’re interested in learning more on how you may qualify for PEARL, check out eligibility requirements and additional information here.


Pride Pledges Now Shipping

Posted on 10/05/2021 by Steve Hill

Just a quick update to let you know that we are now shipping the pride packs with buttons and stickers to backers starting this week. We are also preparing the books and T-shirts to ship just as soon as the garments have been printed and returned to us.


Rewards

Posted on 07/04/2021 by Steve Hill

Thank you once gain for supporting the PEARL campaign!

This is just a quick update to let you know that we engaging with our reward fulfilment manager and will be arranging the production and shipping of the T-shirts, buttons, and other physical rewards in the coming weeks.

For the non-physical rewards such as Q&A with the team we will be following up with you soon. We will keep you updated as things develop.

Thank you, and all of you in the USA have a Happy 4th of July!


August 2023 PEARL Update

Posted on 08/29/2023 by Steve Hill

Good news! We have received an update from the PEARL team. Clinical trials are a slow and time consuming process, but there has been some progress which appears below:

We are grateful for your continued engagement and interest in the PEARL trial. We are excited to provide an update on our progress and the current status of the trial.

Trial Progress Highlights:
As of 08/29/23, we are pleased to report that the PEARL trial has successfully enrolled 122 individuals. Among them, 59 participants have successfully completed the trial, 53 participants are on track to conclude their participation by the end of December 2023, and 10 participants have withdrawn from the study.

Data Analysis and Insights:
Our dedicated clinical team has accumulated a variety of data from our participants over the past year. Such data includes DXA scans, Quest bloodwork panels, DNA Methylation, gut health, and more. The next phase, which we are now setting infrastructure up for, involves an in-depth analysis to gather meaningful insights.

Safety and Adverse Events Monitoring:
Regarding participant safety and engagement. Unfortunately, we lost one participant due to causes unrelated to the trial medication. The remaining 9 participants opted to withdraw from the trial due to side effects or their hesitance regarding the placebo arm.

Data Collection and Partnerships:
Our data collection process is proceeding as expected. Home-based kits from TruDiagnostics, Thorne, and GlycanAge continue to be a key part of our data collection strategy. Ongoing quality assurance checks have been conducted to validate the accuracy of submitted kits. On the in-person front, safety blood panels and DEXA scans are proceeding as expected. We’ve also managed to biobank blood/plasma/serum pre/post samples from 30 participants for future analysis.

Pharmacy Supply and Participant Support:
We are pleased to share that participants have been consistently receiving their medications (5mg, 10mg, & Placebo) from our partner pharmacy without any supply or shipping disruptions.

Upcoming Webinar and Future Milestones:
In September, we are excited to record and share an “Interpreting Your Results” webinar hosted by Dr. Zalzala. This session aims to empower participants by educating them on how to read their individual results from bloodwork, DEXA scans, at-home kits, and post-trial information.


17 Comments

  1. Dr. Desmond Menon

    Hi there,
    This sounds like an interesting clinical trial.
    I might have interested funders for your project.
    Please provide more information on your clinical study, stage, and company along with how we can be involved.
    Kind regards,

  2. Moya

    Thank you for the great work, I hope you will reach the funding goal very soon! :)

    I was wondering about the “Receive all tests that make up the PEARL protocol” reward – are these tests simple to do at home, or would I need to find some medical person who is willing to do them with me?
    And do these tests ship worldwide (in my case to Europe), or are there problems due to interesting chemicals in them?

    • Anar

      Hi Moya,
      Thanks for your question and interest.
      The tests are NOT do at home tests. They will be collected by specialized phlebotomists who would come to participants residences, collect blood and send it to the blood bank.

      We currently don’t have a plan for offering this service to folks in Europe. I would need to research this to see
      1. if we can have a phlebotomist perform blood draw in Europe
      2. if they can ship blood to blood bank in US in an appropriately timely manner.

      I will try to find an answer as soon as possible but in the meantime, I am afraid that the answer is that it is not available in Europe.

      Anar

      • Moya

        Thank you very much – it would have been silly to go for this particular reward and to then not be able to make use of it.

        I think I will just go for a different backing amount then – no problem at all. :)

  3. joker Karlsson

    I would love to be one of the 200 test subject. How do i volunteer?

    • Anar

      Thanks for your question.
      This is the first of potentially many trials. If this trial’s unique philanthropy- and citizen- funded method ends up working successfully it will open the door for other trials; D/Q being one of them.

      • Neil Christensen

        Awesome! I look forward to supporting many more! I agree senolytics is a great target. I would also love to see an NBE human clinical trial, probably with recombinant human serum albumin, in the near term.

  4. louisbreone

    Does the PEARL trial have the same purpose as the TAME trial ?

    That is , provide strong evidence that rapamycin can , like metformin in the TAME trial , target aging and thus prevent most age-related diseases?

    And in the long term, could rapamycin be approved for aging when there is sufficient evidence , as the TAME trial with metformin hopes ?

  5. Art

    Main or only problem is to find the “correct” individual dosage ! A very tricky difficulty. Learn from resTORbioΒ΄s failure

  6. Moya

    As we are getting close to reaching the first Stretch Goal I was wondering:
    The text says that the first Stretch Goal is at $120,000, but the little progress bar on the right says that the first Stretch Goal is at $125,000.
    So which one is it? :)

  7. Steven

    Now that you’ve hit the 2nd stretch goal, can you comment on what will be done with additional funds beyond the $150k?

    • anar

      Hi Steven,
      Thanks for your question.

      The additional funds will allow us to measure additional biomarkers.
      The base case budget is for measuring:
      IGF-1 (fasting)
      Lipid Panel, Standard
      TNFa
      IL-6
      VLDL
      Comprehensive Metabolic Panel*
      HgAC1
      Uric Acid
      CBC & DIFF
      CD4/CD8
      CMV IgG titers
      hs-CRP
      Vitamin D, 25-OH Total (VIT D,25-OH,TOTAL,IA)
      sirolimus level

      Additional funds will be used to measure additional biomarkers, in particular:
      Cystatin C
      GDF 15
      Adiponectin
      Leptin

      I hope this answers your question.

  8. Anar

    Hi Steven,
    Thanks for your question.

    The additional funds will allow us to measure additional biomarkers.
    The base case budget is for measuring:
    IGF-1 (fasting)
    Lipid Panel, Standard
    TNFa
    IL-6
    VLDL
    Comprehensive Metabolic Panel*
    HgAC1
    Uric Acid
    CBC & DIFF
    CD4/CD8
    CMV IgG titers
    hs-CRP
    Vitamin D, 25-OH Total (VIT D,25-OH,TOTAL,IA)
    sirolimus level

    Additional funds will be used to measure additional biomarkers, in particular:
    Cystatin C
    GDF 15
    Adiponectin
    Leptin

    I hope this answers your question.

  9. Chuong Nguyen

    Great initiative and community involvement! Come here after Prof David Sinclair’s Tweet. @Anar thank you for sharing more information. I assume this research recruits people in US only.

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