Objective: This presentation will review and discuss the role of magnetic resonance imaging markers as outcomes in dementia clinical drug trials.
Design: Interest in such markers has been focused on their possible role in demonstrating disease-modifying effects of antidementia drugs.
Materials and Methods: Magnetic resonance spectroscopy (MRS), magnetic resonance volumetrics and positron emission tomography (PET) have been proposed as outcome measures in phase 2 and phase 3 trials of dementia drugs.
Results: On Nov 18, 2002, the US Food and Drug Administration conveyed a group of experts of review the role of brain imaging as an outcome measure in dementia trials.
Conclusion: In general, it was felt that volumetric imaging and PET had the most promise, but that additional evidence was needed to validate these surrogate markers. In addition to reviewing some of these data, I will present data from recently completed randomized trial in which MRS and volumetric imaging were used as outcome measures.
Back to S038 Clincal Advances in Mild Cognitive Impairment and Alzheimer’s Disease
Back to The Eleventh International Congress