September 17, 1999--Hormone replacement therapy has been shown to protect women against heart disease, stroke and Alzheimer's disease. Now, researchers at Rush-Presbyterian-St. Luke's Medical Center have begun a clinical trial to determine if estrogen also improves the effectiveness of drugs used to treat Parkinson's patients.
Currently the most common treatment for Parkinson's patients is a daily regimen of the drug Levodopa. While many patients benefit from consistent use of Levodopa, the effects of the drug wear off after two or three hours, creating a "roller coaster" effect. Recently, a drug called Mirapex has proven effective at leveling these ups and downs, and preliminary information suggests hormone replacement therapy can enhance these effects.
Dr. Aikaterini Kompoliti, a neurologist at Rush-Presbyterian-St. Luke's Medical Center, is heading a team of researchers investigating whether estrogen can extend this period of effectiveness and further smooth out the ups and downs caused by Levodopa.
Rush is one of two medical centers taking part in this double-blind, placebo trial that will study 36 patients. The other center is the Mayo Clinic in Scottsdale, Ariz.
Parkinson's occurs when the brain cannot produce enough dopamine, causing patients to lose the ability to control their own movements. Levodopa and Mirapex are dopamine agonists that work by fooling the brain into thinking that dopamine exists. When effective, these medications allow patients to regain some control over their motor functions.
"Our hypothesis is that estrogen will work with the Mirapex and Levodopa to increase and enhance the effectiveness of both drugs," said Kompoliti. Each medical center in the trial will treat 18 patients who are already on Levodopa: six will be men on Levodopa; six will be post-menopausal women on Levodopa, but not estrogen; and six will be post-menopausal women on Levodopa and estrogen. All patients will be started on Mirapex or a placebo. Both patients and researchers will be blinded. (Neither patients nor doctors will know if patients are on Mirapex or placebo.) The medication will be given for two months. Every female participant will receive a complete gynecological exam as well as a free mammogram. At the end of the trial, every patient will receive a year's supply of Mirapex, from Pharmacia & Upjohn, Inc. Pharmacia & Upjohn Inc. manufactures Mirapex and is the sponsor of this clinical trial.
To participate in the study, patients must have advanced Parkinson's disease. Interested parties should call 312-942-5936.
Rush-Presbyterian-St. Luke's Medical Center includes the 809-bed Presbyterian-St. Luke's Hospital; 154-bed Johnston R. Bowman Health Center for the Elderly; Rush University (Rush Medical College, College of Nursing, College of Health Sciences and Graduate College); and seven Rush Institutes providing diagnosis, treatment and research into leading health problems. The medical center is the tertiary hub of the Rush System for Health, a comprehensive healthcare system capable of serving about three million people through its outpatient facilities and eight member hospitals.