🧪 TAME Trial Metformin Aging Endpoint Simulator

Aging Itself as a Trial Target

Placeholder: TAME reframes aging as a treatable condition, not a backdrop.

• Metformin: Proposed drug (Placeholder note)
• 2015: Trial concept year (Placeholder note)
• Age 65–79: Target population (Placeholder note)
• N. Barzilai: Lead investigator (Placeholder note)

Why aging qualifies as an indication

Placeholder: short rationale for treating aging as a single modifiable process.

Composite Multi-Morbidity Endpoint Design

Placeholder: one endpoint bundles heart disease, cancer, dementia, and death.

• 4+: Endpoint diseases (Placeholder note)
• Time-to-event: Primary metric (Placeholder note)
• Multi-morbidity: Composite type (Placeholder note)
• Cox hazard: Statistical model (Placeholder note)

Bundling diseases into one measurable outcome

Placeholder: short description of how the composite endpoint is built.

Time-to-First-Age-Related-Disease Outcome

Placeholder: each participant is followed until their first qualifying event.

• First event: Outcome type (Placeholder note)
• Survival curves: Tracking method (Placeholder note)
• Placebo arm: Comparator (Placeholder note)
• ~2–3 yrs: Expected delay (Placeholder note)

Modeling delayed disease onset

Placeholder: short description of time-to-first-disease modeling.

Large Elderly Cohort Recruitment

Placeholder: thousands of older adults recruited across many clinical sites.

• 3,000: Planned cohort (Placeholder note)
• ~14: Site count (Placeholder note)
• 65–79: Age range (Placeholder note)
• 5–6 yrs: Follow-up (Placeholder note)

Recruiting a representative elderly cohort

Placeholder: short description of recruitment and site strategy.

Regulatory Precedent for Anti-Aging Trials

Placeholder: TAME could establish an FDA pathway for aging indications.

• Novel: FDA pathway (Placeholder note)
• None: Prior precedent (Placeholder note)
• Pending: Funding status (Placeholder note)
• High: Field impact (Placeholder note)

Opening the door for future geroprotector trials

Placeholder: short description of downstream regulatory impact.

Placeholder: short callout on why this precedent matters for the field.