Propentofylline in the treatment of Alzheimer's disease and vascular dementia: a review of phase III trials.

Propentofylline, a neuroprotective glial cell modulator, has been shown in preclinical studies to address some of the common pathological processes of Alzheimer's disease (AD) and vascular dementia (VaD), including glial cell activation and increased production of cytokines, free radicals, and glutamate. To examine whether propentofylline (300 mg t.i.d. taken 1 h before meals) would provide beneficial effects in patients with AD and/or VaD, 901 patients with mild-to-moderate AD and 359 patients with mild-to-moderate VaD were enrolled in four double-blind, placebo-controlled, randomized studies ranging in duration from 6 months to 56 weeks. Propentofylline was found to provide consistent improvements over placebo in efficacy assessments for both AD and VaD patients. In addition, results from a drug withdrawal study suggested that propentofylline does not merely relieve dementia symptoms but slows the progression of the disease itself. Propentofylline had a good safety profile and was generally well tolerated.