Phase III Results With H-R's Propentofylline

14 November 1994

Hoechst-Roussel's antidementia drug propentofylline is effective in patients with cerebrovascular dementia or Alzheimer's dementia, according to the results of three Phase III European trials. Propentofylline, a xanthine derivative, is thought to act by reinforcing the neuroprotective actions of adenosine and cyclic AMP, in particular by preventing excessive microglial activation which is a feature in both Alzheimer's and cerebrovascular dementia.

Barbara Kittner, clinical project manager at Hoechst Roussel's Strategic Business Unit for Cardiovascular Agents, based in Wiesbaden, Germany, presented details of one of the trials at a company press seminar last week. This study lasted one year and there was a benefit from propentofylline throughout the treatment period.

A total of 260 men and women with mild-to-moderate dementia (about 65% of the patients had Alzheimer's disease) received either placebo or 300mg tid of propentofylline one hour before meals for 12 months in the multicenter study. 33% of patients withdrew from propentofylline therapy while 23% withdrew in the placebo group. Adverse events were the cause of withdrawal in 12% of the drug-treated patients and 8% of the placebo group, said Dr Kittner. The principle side effects of propentofylline consisted of headache, nausea, gastrointestinal pain or dizziness, which were usually transient.

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