erceptive Informatics, the eClinical subsidiary of US-based contract research organisation Parexel International Corporation, has developed a “robust” new medical imaging methodology for central nervous system (CNS) trials involving Alzheimer’s disease.
The method, based on measuring ventricular size, offers a new approach to monitoring brain atrophy in Alzheimer’s and potential treatment effects, Perceptive said. It was developed with the help of magnetic resonance imaging scans collected from the database of the Alzheimer’s Disease Neuroimaging Initiative (ADNI).
Based in San Francisco, California, the ADNI is focused on defining the rate of progress of mild cognitive impairment and Alzheimer’s disease, developing improved methods for clinical trials in the field, and assembling a large database that will improve the design of Alzheimer’s treatment studies.
It involves a five-year research project, started in October 2004 and looking at changes in cognition, function, brain structure and biomarkers in 200 elderly controls, 400 subjects with mild cognitive impairment, and 200 with Alzheimer’s disease.
The US National Institute of Aging and the National Institute of Bioimaging and Bioengineering provided US$40 million of the total US$60 million in funding for the project, with the remainder coming from the pharmaceutical industry and various foundations.
As Perceptive Informatics noted, making accurate go/no go decisions as early as possible in clinical development is now “more critical than ever” for the biopharmaceutical industry. Medical imaging is increasingly used as a surrogate endpoint or biomarker of drug efficacy in all phases of CNS trials.
"Based on ADNI data, measuring ventricular change may be one of the most robust outcomes for imaging progression of Alzheimer’s disease,” commented Dr James Paskavitz, medical director of Perceptive Informatics.
Perceptive has developed a novel method of ventricular measurement that accurately reflects brain atrophy, he said, adding: “We believe that this method can support sponsors in reducing the time, cost, and risk associated with clinical development of Alzheimer’s treatments by providing medical image data that informs early phase decisions and is reproducible for later phase, multicentre trials.”