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A randomized control trial to establish the feasibility and safety of rapamycin treatment in an older human cohort

Kraig E, Linehan LA, Liang H, Romo TQ, Liu Q, Kellogg DL · 2018 · Experimental Gerontology · Atlas ID KRA2018

What this study shows

A safety-first pilot RCT (n=25, ages 70-95) asking the basic question before any longevity trial: is daily rapamycin safe in healthy older people? Over 8+ weeks it was well tolerated with only minor red-blood-cell changes and - importantly - NO rise in blood glucose or insulin resistance in this short window. Groundwork for larger aging trials like PEARL.

Abstract

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Inhibition of the mechanistic target of rapamycin (mTOR) pathway by rapamycin (RAPA), an FDA-approved immunosuppressive drug used as a clinical therapy to prevent solid organ allograft rejection, enhances longevity in mice. Importantly, RAPA was efficacious even when initiated in relatively old animals, suggesting that mTOR inhibition could potentially slow the progression of aging-associated pathologies in older humans (Harrison et al., 2009; Miller et al., 2011). However, the safety and tolerability of RAPA in older human subjects have not yet been demonstrated.

Read the full abstract on PubMed →

At a glance

Evidence type H Human study Marked H because it is direct evidence from a human clinical trial or human cohort; the code names the kind of study, not its quality -- a small, well-run trial is still H.
Study type2 - Human Clinical Trial
Model systemHumans, pilot RCT (n=25, ages 70-95)
JournalExperimental Gerontology
Year2018
Peer reviewedYes
Record last updated2026-08-22
SourceDOI 10.1016/j.exger.2017.12.026 · PMID 29408453 · Free full text (PMC5869166)

Extracted findings

InterventionRapamycin (oral, daily, ~8 weeks)
TargetmTOR / mTORC1
ModelHuman – healthy older adults (age 70–95, n=25)
EffectWell tolerated; NO rise in blood glucose / insulin resistance in the short window – groundwork for larger geroprotection trials
DoseRapamycin 1 mg daily orally (single dose tested; blood levels monitored in first 4 subjects), ~8-16 weeks; placebo-controlled.
Sample sizeHealthy older adults (ages 70-95); phase-1 subset = 8 subjects (half rapamycin / half placebo), 4-month protocol.
Effect sizeEstablished feasibility and safety of daily low-dose rapamycin in older adults; no serious adverse events; groundwork for larger geroprotection trials.
LimitationsSmall sample -> single 1 mg dose chosen; short duration; feasibility (not efficacy) study.

In the Atlas

Related topics

LongevityRapamycinImmune functionmTORC1

Answers that reference this study

More studies on this topic

Cite this paper

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Kraig, E., Linehan, L. A., Liang, H., Romo, T. Q., Liu, Q., & Kellogg, D. L. (2018). A randomized control trial to establish the feasibility and safety of rapamycin treatment in an older human cohort. Experimental Gerontology. https://doi.org/10.1016/j.exger.2017.12.026

@article{KRA2018,
  author       = {Kraig, E. and Linehan, L. A. and Liang, H. and Romo, T. Q. and Liu, Q. and Kellogg, D. L.},
  title        = {{A randomized control trial to establish the feasibility and safety of rapamycin treatment in an older human cohort}},
  journal      = {Experimental Gerontology},
  year         = {2018},
  doi          = {10.1016/j.exger.2017.12.026},
  note         = {PMID: 29408453},
}

Cite this Atlas record

The record is the Atlas's own work — the evidence label, the extracted findings and the links. It is cited as part of the dataset, not as the paper. 

Barton, O. (2026). Oliver's mTOR Atlas (record KRA2018) [Data set]. https://mtor-atlas.org/study/KRA2018/ · Dataset DOI 10.5281/zenodo.22059963

@misc{atlas_KRA2018,
  author       = {Barton, Oliver},
  title        = {{Oliver's mTOR Atlas}, record KRA2018},
  howpublished = {Data set},
  year         = {2026},
  url          = {https://mtor-atlas.org/study/KRA2018/},
  doi          = {10.5281/zenodo.22059963}
}