A Boston company is nearing the final phase of testing a diagnostic drug that could offer health-care providers a long-awaited medical test for attention deficit hyperactivity disorder.
Boston Life Sciences Inc. announced this month that its product Altropane was successful in identifying adults who had been clinically diagnosed with long- standing ADHD by mapping the level of certain chemicals in their brain.
ADHD is the most commonly diagnosed behavioral disorder in American children, affecting an estimated 2 million school-age youngsters, according to the National Institutes of Health. Characterized by hyperactivity, short attention spans, and impulsivity, the condition often interferes with a child’s education.
No biological test for diagnosing ADHD is currently available, a situation that some experts contend has led to the misdiagnosis and unnecessary medication of many children. Currently, psychiatrists often rely heavily on reports from parents and educators about children’s behavior in making a diagnosis.
Researchers working on the development of Altropane say their study has shown abnormally high levels of the neurotransmitter dopamine in the brains of people with ADHD, which means a medical diagnosis may not be far away.
“Because of the national controversy presently surrounding the confusion and inconsistencies in the clinical diagnosis of ADHD, and the growing concern over the abuse of stimulant medications by schoolchildren, we believe that the need for an objective, biologically based diagnosis for ADHD has never been greater, nor more urgent for society,” Marc Lanser, Boston Life Science’s chief scientific officer, said in a written statement.
Under guidelines set by the U.S. Food and Drug Administration, the company conducted the first test of its imaging product in 1999 on 10 adult volunteers, six with ADHD, and increased the number of test subjects to 40 for the second phase. The results of the first study were published in The Lancet, a London-based journal of medicine.
The third and final trial of Altropane is to begin this summer with 100 adult test subjects.
Once the testing is wrapped up, Boston Life Sciences will apply to the FDA for fast-track approval to market the product, said Maria Zapf, the company’s manager of corporate affairs.
“Hopefully, this kind of product will quell a little of the controversy over whether ADHD is an actual disorder,” Ms. Zapf said.
Coverage of research is underwritten in part by a grant from the Spencer Foundation.
A version of this article appeared in the March 28, 2001 edition of Education Week as Firm Moves Closer To Brain-Imaging Test for ADHD