Sanofi-Aventis, a Malverne, Pa.-based pharmaceutical company, is enrolling subjects in a study of a new treatment to help schizophrenia patients improve cognitive functioning. Although a press release was sent to Jewish newspapers in this area, according to Brian Gaines, trial manager at Sanofi-Aventis, Jewish subjects are not specifically being recruited; the company is looking for any schizophrenia patients who are stable and relatively healthy. The drug, which is a new compound developed by his company, is thought to work by suppressing certain responses in the brain. It is designed to help patients who have cognitive impairment, that is, according to the press release, “people with schizophrenia [who] struggle to concentrate, remember, and learn.”
In addition to determining whether this new drug can help patients, Gaines explained that the study will test the application of a battery of cognitive tests to evaluate progress in patients. The new evaluation tool, called MATRICS (Measurement and Treatment Research to Improve Cognition) is used to measure each patient’s progress throughout the study. A team of statisticians and research scientists working with the FDA has developed this cognitive battery. Gaines reported that trained “raters” will administer the MATRICS test four times during the six-month study to determine whether subjects are improving in cognitive functioning. “This is the largest study using the MATRICS cognitive battery,” said Gaines. If it proves effective, the evaluation tool will be used for testing other drugs that can potentially improve thinking. “It will make it easier to get drugs on the market to help patients with this type of cognitive issue,” Gaines added.
Gaines reported that researchers are at least halfway through the study. According to information on www.clinicaltrials.gov, the plan is to test the drug on 692 subjects. “We have at least 50 centers across the U.S.,” said Gaines. “It is a very difficult study,” he added. “It involves testing, and rater training, and the subjects are in the study a long time. Getting them back [to test] is a challenge.”
Patients eligible for this study must be between the ages of 18 and 65, and have been diagnosed with schizophrenia at or before the age of 35. Since this new experimental drug (administered daily, in pill form) is intended to supplement current treatment, subjects must already be taking one of five medications for schizophrenia: olanzapine, risperidone/paliperidone, quetiapine, or aripiprazole. The press release adds, “Participants must also be considered outpatients…. Qualified study participants will receive all investigational medication and study-related care at no cost, and may also receive compensation for travel.”
When considering whether to volunteer for a clinical study, people should learn how the study is designed and what it hopes to accomplish, as well as weigh the potential risks and benefits.
The Sanofi-Aventis research study is listed on the National Institutes of Health Website and is registered as an approved Phase II, randomized, double-blind clinical study. A Phase II study is conducted after preclinical testing on cells and animals in the lab and after the first stage of testing with small groups of human subjects has assessed the safety and tolerability of a drug. Randomized double-blind studies are considered the gold standards of scientific research, since groups of subjects are randomly assigned treatments. This means that some of the participants receive different doses of the drug (or drugs) and some receive a placebo (inert substance). “Double blind” refers to the fact that the treatments are coded; at the time of the study and collection of data, neither the subjects nor the investigators know which treatment any given subject is receiving. After data are collected and analyzed, the code is broken so that the investigators can determine the effectiveness of treatment.
The project has research sites at Weill Cornell Medical College in Manhattan and White Plains, N.Y. (914-682-6974), at SUNY Downstate Medical Center in Brooklyn, N.Y. (718-270-2004) and at Neurobehavioral Research, Inc., in Cedarhurst, N.Y. (516-295-7230). More information can be obtained by calling (888) 988-6736 or on the web at www.cognitivestudy.com.