National study to evaluate the effectiveness Targacept

Apr 27 2005

Wake Forest University School of Medicine is one of 15 centers nationwide recruiting participants for a research study to evaluate the effectiveness of an investigational drug as an oral treatment for age associated memory impairment (AAMI), a condition that is marked by memory loss and poor concentration.

The investigational drug, ispronicline, is being developed by Targacept Inc., a biopharmaceutical company based in Winston-Salem. Ispronicline stimulates receptors in the brain that regulate attention/concentration, memory and mood.

“AAMI occurs in over one-third of people at the age of 65 or older and often begins at earlier ages,” said Nancy Woolard, project manager and administrator for the Roena Kulynych Center for Memory and Cognition Research at Wake Forest University Baptist Medical Center. “As the population ages, there is a growing need for drugs that improve concentration and memory.”

In a variety of preclinical studies, ispronicline exhibited memory-enhancing properties. Later studies by Targacept evaluated the safety and tolerability of ispronicline in humans. The current 18-week study will involve 174 people nationwide. The goal is to assess ispronicline’s effects on cognition in individuals with AAMI. Jeff D. Williamson, M.D., director of the Kulynych Center, is the principal investigator for the Wake Forest Baptist site.

“We are recruiting people from 50 to 80 years old who have AAMI,” Woolard said. “For example, the typical volunteers for this study would be individuals who are still performing their everyday activities but they or their family have recently noticed that they just don’t remember things quite as well as they used to.”

Study participants must have someone who lives with them who can report on their cognitive function. “People who are starting to develop cognitive impairment often don’t fully realize it, or they can’t give you an accurate assessment of their impairment,” Woolard said. “So we need input from someone who lives with them every day.”

After an extensive initial screening to determine if their cognitive function meets the study criteria, those chosen for the study will take either a daily tablet of ispronicline or a placebo (an inactive substance). “Throughout the study, participants will participate in a battery of cognitive tests to determine if their cognitive function has improved,” Woolard said.

Targacept Inc. is an emerging biopharmaceutical company engaged in the design, discovery and development of drugs to treat central nervous system diseases and disorders.

People interested in participating in the study, at either the Winston-Salem or the Greensboro clinic location, should call (877) 238-4825.