Program: The National Institute of Aging (NIA) initiated the ITP to evaluate compounds or diets thought to extend longevity in mice by delaying or decelerating the aging process.
The Phase I experimental design has the following features:
- The primary endpoint is increased longevity.
- Test subjects are male and female genetically heterogeneous mice, bred as the four-way cross between CByB6F1 females and C3D2F1 males.
- Tests are conducted simultaneously at three sites: the University of Michigan, the Jackson Laboratory, and the NIA Intramural Program.
- The design compares multiple experimental agents to two control groups.
- Feeding of the test diets usually starts at 4 Months of age unless there are specific reasons for another time of initiation.
- Mice also are tested for several age-sensitive traits, such as T-cell subsets, humoral immunity, changes in hormone levels, and spontaneous activity.
- Agents that show promise in the initial screen are considered for the Phase II testing, a follow-up lifespan studies that includes multiple age-sensitive traits and detailed pathology.
- Group size is sufficient to detect 11 percent change in longevity at 80 percent power and 13 percent change at 90 percent power.
- All findings—positive or negative—are submitted for publication.
Currently, the NIA seeks proposals for specific compounds or dietary agents to be included in Phase I screening. The applicant, or “sponsor”, designs and justifies the specific treatment protocol and collaborates in evaluating the results and preparing them for publication. Sponsors can be individuals, nonprofit or academic groups, or commercial concerns. NIA is responsible for the costs of the testing through the grants to the three testing sites.
Deadline: September 30, 2013.