NMA: Nonprescription Medicines Academy

Citicoline Proves Safe, Effective in Mild Vascular Cognitive Impairment

April 17th, 2013

Data from the multicenter Italian studio di intervento nel decadimento vascolare lieve (IDEALE study) show the dietary supplement citicoline to be effective and well tolerated in patients with mild vascular cognitive impairment.

Citicoline activates biosynthesis of phospholipids in neuronal membranes, increases brain metabolism as well as norepinephrine and dopamine levels in the central nervous system, and has neuroprotective effects during hypoxia and ischemia. In the IDEALE study, 349 patients 65 years of age or older were assigned to open-label treatment with oral citicoline 500 mg twice daily or no treatment (controls). The citicoline group included 122 men and 143 women with a mean age of 79.9 ± 7.8 years; the control group included 36 men and 48 women with a mean age of 78.9 ± 7.01 years. The primary study outcomes were improvement in scores on the Mini-Mental State Examination (MMSE), Activities of Daily Living (ADL) scale, and Instrumental Activities of Daily Living (IADL) scale in the citicoline group compared with the control group. Assessments were made at baseline (T0), after 3 months (T1), and after 9 months (T2).

The mean MMSE score in the citicoline group remained essentially unchanged over time (22.4 ± 4 at T0; 22.7 ± 4 at T1; 22.9 ± 4 at T2), whereas the mean MMSE score in the control group declined by 1.9 points over 9 months (21.5 ± 6.9 at T0; 20.4 ± 6.6 at T1; 19.6 ± 6.3 at T2). The differences between the citicoline and control groups were significant at T1 and T2 (P = 0.0001). No differences were found in ADL and IADL scores between the two groups. Adverse events were limited to reports of occasional excitability or restlessness (5.6% of cases), digestive intoler¬ance (4. % of cases), and self-limiting headache (3.6% of cases).

The authors cautioned that further studies are needed to confirm these results and to assess the efficacy and safety of long-term administration of citicoline.

Clin Interv Aging. 2013;8:131-7. Epub 2013 Feb 5.