Hippocampal Volume and Magnetic Resonance Imaging Markers in Clinical Trials

P. Murali Doraiswamy, Psychiatry, Psychiatry, Duke University, Durham, NC, USA

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.