News
Propentofylline for Alzheimer's, Dementia
Patients with Alzheimer's disease and vascular dementia responded well to propentofylline, a drug that may become available in the United States within the next few years.
Propentofylline is a phosphodiesterase inhibitor and an inhibitor of adenosine re-uptake. It belongs to a new class of drugs called glial cell modulators, said Carole A. Wilmot, Ph.D., project leader of the Propentofylline Project Team.
In a multicenter prospective study that was conducted by the European-Canadian Propentofylline Study Group, 237 patients with Alzheimer's disease who took propentofylline showed improvements on tests of cognition and global functioning, relative to 241 patients with Alzheimer's who took a placebo, Dr. Wilmot said.
Significant improvements were seen within 24 weeks and were maintained up to 72 weeks.
Improvements also were demonstrated by 210 patients with vascular dementia who took propentofylline, compared with 224 patients with vascular dementia who took a placebo. Significant improvements were seen in these patients within 12 weeks and were maintained up to 48 weeks.
"There was an apparent increase in treatment effect as one went out in time, relative to the placebo. The theory is that we're affecting the underlying progression of disease," she said.
Even 12 weeks after drug therapy had been discontinued, the treated patients continued to score significantly higher than placebo patients on tests including the Alzheimer's Disease Assessment Scale-Cognitive Subscale and the Clinician's Interview-Based Impression of Change With Caregiver Input, Dr. Wilmot reported.
All patients were initially classified with mild to moderate disease, in the 26-18 range of the Mini-Mental State Exam. They were randomized to take 300 mg of either propentofylline or placebo three times a day. The side effects of treatment were most commonly nausea, dizziness, headache, and vasodilatation.
An application to market propentofylline in the United States will be sought in 2002, contingent upon the results of a large, double-blind placebo-controlled U.S. test that will begin in early 2000, Dr. Wilmot of Hoechst Marion Roussel in Bridgewater, N.J., said in an interview.