| Literature DB >> 19595873 |
Abstract
There are many who feel that the achievement of a disease-modifying (DM) designation for a drug is an important goal in Alzheimer disease (AD) therapeutics. Several designs that might prove DM have been proposed, including randomized start, randomized withdrawal, and slope analysis. Using biomarkers such as cerebrospinal fluid assays or imaging features as primary outcome measures have also been considered a way of proving DM. The available methods for establishing DM are fraught with logistical and analytic problems. Unless the drug's benefits are large, attempts to prove DM for a truly effective drug may fail. Therefore, clinical trial designs that are the simplest to conduct and interpret are superior to those more complex approaches intended to prove DM.Entities:
Year: 2006 PMID: 19595873 DOI: 10.1016/j.jalz.2006.03.010
Source DB: PubMed Journal: Alzheimers Dement ISSN: 1552-5260 Impact factor: 21.566