NCT02637518 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Fried LP, Guralnik JM
Disability in older adults: evidence regarding significance, etiology, and risk. J Am Geriatr Soc. 1997 Jan;45(1):92-100. Review.
Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group
Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56.
García-García FJ, Carcaillon L, Fernandez-Tresguerres J, Alfaro A, Larrion JL, Castillo C, Rodriguez-Mañas L
A new operational definition of frailty: the Frailty Trait Scale. J Am Med Dir Assoc. 2014 May;15(5):371.e7-371.e13. doi: 10.1016/j.jamda.2014.01.004. Epub 2014 Mar 2.
Gill TM, Gahbauer EA, Allore HG, Han L
Transitions between frailty states among community-living older persons. Arch Intern Med. 2006 Feb 27;166(4):418-23.
Rodriguez-Mañas L, Fried LP
Frailty in the clinical scenario. Lancet. 2015 Feb 14;385(9968):e7-9. doi: 10.1016/S0140-6736(14)61595-6. Epub 2014 Nov 6.
Rodríguez-Mañas L, Sinclair AJ
Frailty: the quest for new domains, clinical definitions and subtypes. Is this justified on new evidence emerging? J Nutr Health Aging. 2014 Jan;18(1):92-4. doi: 10.1007/s12603-013-0433-9.

A Comprehensive Validation of Frailty Assessment Tools to Screen and Diagnose Frailty in Different Clinical and Social Settings and to Provide Instruments for Integrated Care in Older Adults.

Details for clinical trial NCT02637518

Clinical trial NCT02637518 - References