Research Study Tests Investigational Medication for Alzheimer's Disease

CINCINNATI—Approximately 5.4 million Americans are living with Alzheimer’s disease, according to the Alzheimer’s Association, a number that is expected to almost triple to 16 million by 2050.

And with no known cure for dementia of Alzheimer’s type, deaths from the disease increased 66 percent between 2000 and 2008 even as deaths from other major diseases such as heart disease and stroke decreased. Alzheimer’s is now the sixth-leading cause of death in the U.S.

Researchers at the University of Cincinnati (UC) Department of Psychiatry and Behavioral Neuroscience are participating in an international, multi-site phase 2 clinical research study to test an investigational medication known as SAR110894D on the cognitive performance of study participants with mild to moderate Alzheimer’s disease. The medication, taken orally, is manufactured by Sanofi-Aventis U.S., which is sponsoring the study.

"Alzheimer’s disease is a devastating illness because not only does it affect patients, but it also affects families as well” says Muhammad Aslam, MD, principal investigator at the UC site and an assistant professor in the department of psychiatry and behavioral neuroscience. (The Alzheimer’s Association reported earlier this year that the number of Americans living as caregivers to someone with Alzheimer’s or a different type of dementia is 15 million.)

"While there is no known cure for Alzheimer’s, some medications exist to manage or slow down its symptoms,” Aslam says. "This study will accept participants who are already taking such a medication, donepezil (brand name Aricept), and test the safety and effectiveness of an additional medication.”

Study participants must be taking donepezil for the treatment of Alzheimer’s and be able to live independently, but still require assistance from a family member or a caregiver on a regular basis. Participants must be 55 or older, have a diagnosis of mild to moderate Alzheimer’s, and have the family member or caregiver willing to accompany them for each study visit.

Study participants will receive either the investigational medication or a placebo, in addition to their regular donepezil therapy. Total study duration for each patient is up to 38 weeks. Study treatment will be provided at the Stetson Building in Clifton, home to UC Health outpatient psychiatry.

Participants will receive the medicine at no cost, along with study-related assessments including blood tests, electrocardiograms, physical exams, eye exams and memory and other cognitive tests. Both caregivers and patients will be compensated for time and travel at each study visit.

Aslam reports no financial interest in Sanofi-Aventis U.S.

For information on the clinical study, contact Stephanie Nolting, the study coordinator, at 513-558-7183.