Cilostazol safe but not neuroprotective

In the treatment of people with mild cognitive impairment, cilostazol is well tolerated but falls short of preventing further cognitive decline, according to the results of the phase II COMCID* trial.

COMCID included 159 patients (mean age, 75.6 years; male, 41.5 percent) who had Mini-Mental State Examination (MMSE) scores of 22–28 points (on a scale of 0–30, with lower scores indicating greater cognitive impairment) and Clinical Dementia Rating scores of 0.5 points (on a scale of 0, 0.5, 1, 2, and 3, with higher scores indicating more severe dementia). These patients were randomly assigned to receive either placebo or cilostazol 50 mg twice daily for up to 96 weeks.

The primary endpoint of change in the total MMSE score from baseline to the final observation did not significantly differ between the two treatment groups. The least-squares mean changes in the MMSE scores in the placebo group were –0.1 at 24 weeks, –0.8 at 48 weeks, –1.2 at 72 weeks, and –1.3 at 96 weeks. On the other hand, the least-squares mean changes in MMSE scores in the cilostazol group were –0.6 at 24 weeks, –1.0 at 48 weeks, –1.1 at 72 weeks, and –1.8 at 96 weeks.

In terms of safety, two patients in the placebo group and three in the cilostazol group discontinued treatment due to adverse effects (2.5 percent vs 3.8 percent). A single case of subdural haematoma possibly related to treatment was documented in the cilostazol group, with the patient successfully treated surgically.

*A Trial of Cilostazol for Prevention of Conversion from Mild Cognitive Impairment to Dementia