Effectiveness and safety of citicoline in mild vascular cognitive impairment: the IDEALE study

Abstract

BackgroundThe studio di intervento nel decadimento vascolare lieve (IDEALE study) was an open multicenter Italian study, the aim of which was to assess the effectiveness and safety of oral citicoline in elderly people with mild vascular cognitive impairment.MethodsThe study was performed in 349 patients. The active or citicoline group was composed of 265 patients and included 122 men and 143 women of mean age 79.9 ± 7.8 years selected from six Italian regions. Inclusion criteria were age ≥ 65 years, Mini-Mental State Examination (MMSE) score ≥ 21, subjective memory complaints but no evidence of deficits on MMSE, and evidence of vascular lesions on neuroradiology. Those with probable Alzheimer’s disease were excluded. The control group consisted of 84 patients, including 36 men and 48 women of mean age 78.9 ± 7.01 (range 67–90) years. Patients included in the study underwent brain computed tomography or magnetic resonance imaging, and plasma dosage of vitamin B12, folate, and thyroid hormones. Functional dependence was investigated by scores on the Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) scales, mood was assessed by the Geriatric Depression Scale (GDS), and behavioral disorders using the Neuropsychiatric Inventory scale. Comorbidity was assessed using the Cumulative Illness Rating Scale. An assessment was made at baseline (T0), after 3 months (T1), and after 9 months (T2, ie, 6 months after T1). The main outcomes were an improvement in MMSE, ADL, and IADL scores in the study group compared with the control group. Side effects were also investigated. The study group was administered oral citicoline 500 mg twice a day throughout the study.ResultsMMSE scores remained unchanged over time (22.4 ± 4 at T0; 22.7 ± 4 at T1; 22.9 ± 4 at T2), whereas a significant difference was found between the study and control groups, both in T1 and in T2. No differences were found in ADL and IADL scores between the two groups. A slight but not statistically significant difference was found in GDS score between the study and control groups (P = 0.06). No adverse events were recorded.Conclusion:In this study, citicoline was 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. Therefore, citicoline may be recommended for patients with mild vascular cognitive impairment.

Improvements in concentration, working memory and sustained attention following consumption of a natural citicoline–caffeine beverage

“…Results from this study are consistent with prior research that suggests citicoline may play a role in increasing attention and alertness (Babb et al, 2002; Bruce, 2012; Cotroneo et al, 2013; Silveri et al, 2008). Citicoline is a compound that consists of cytidine and choline.…”

“…Since PDE has been shown to decrease with age and be associated with cognitive memory loss, increase in this substance may improve overall cognitive skills. In a recent study examining mild cognitive impairment in 349 elderly patients, Cotroneo and colleagues (2013) found that the citicoline group showed improvement in mini mental state examination (MMSE) scores after 9 months, compared to the untreated group that showed significant MMSE declines over the same time period. Other investigators have also found that increases in PDE from citicoline supplements have led to improved memory in older adults (Babb et al, 2002).…”

“…Citicoline, comprised of the combination of cytdine and choline, is a safe and well-tolerated compound that has been shown to increase the levels of choline in the brain and have no adverse systemic cholinergic effects (Conant & Schauss, 2004; Cotroneo et al, 2013; Rossi & Zanardi, 1993; Secades, 2011; Secades & Lorenzo, 2006). In addition to the documented improvements of caffeine on attention and neurocognitive functioning (Einother and Giesbrecht, 2013), choline is important for overall brain health and has been shown to reduce the risk of dementia, stroke and normal age- related memory loss (Gatti et al, 1992; Silveri et al, 2008).…”

Hypoxia/Aglycemia-Induced Endothelial Barrier Dysfunction and Tight Junction Protein Downregulation Can Be Ameliorated by Citicoline

“…More recent evidences suggest that citicoline may increase dopamine production and glutamate uptake in the brain to improve cognition [2], [3]. Citicoline could also reduce free fatty acid release and recover the activities of mitochondrial ATPase and membrane Na + /K + ATPase to alleviate brain damage [4], [5].…”

The role of citicoline in the treatment of dyscirculatory encephalopathy and vascular cognitive impairment

“…Итальянское исследование IDEALE. В 2015 г. были опубликованы результаты открытого многоцентрового исследования, проведенного в Италии, -IDEALE [29]. Его особенность -длительный период наблюдения за пациен-тами (9 мес).…”