On 6 December, Japanese researchers published findings from the COMCID trial in the journal JAMA Network Open. The COMCID trial was a double-blind and Phase II randomised clinical trial investigating the efficacy and safety of cilostazol in people with Mild Cognitive Impairment (MCI). Participants received either placebo or cilostazol (50mg) orally twice daily for up to 96 weeks in Japan. The primary end point was the change in the total Mini-Mental State Examination (MMSE) score from baseline to the final observation. Results showed that there was no statistically significant difference between the placebo and cilostazol groups for the primary outcome. The study did not demonstrate any efficacy in preventing disease progression. However, the findings revealed some interesting observations about the potential effects of cilostazol on beta-amyloid.
The research showed that the blood concentrations of the albumin and β-amyloid complex (albumin-Aβ complex) in participants receiving cilostazol increased following treatment compared with those receiving placebs, suggesting that cilostazol may have promoted the clearance of β-amyloid from the brain into the blood, consistent with the results of past animal experiments. Safety analyses included all adverse events. Authors concluded that the study demonstrated the safety of cilostazol in people with MCI and that the efficacy of cilostazol should be tested in future trials. The researchers plan to identify a group of patients for whom cilostazol is effective (cilostazol-responders) to enable investigation of its anti-dementia effects.