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Alvarez, X. A., Mouzo, R., Pichel, V., Perez, P., Laredo, M., Fernandez-Novoa, L., Corzo, L., Zas, R., Alcaraz, M., Secades, J. J., Lozano, R., and Cacabelos, R. Double-blind placebo-controlled study with citicoline in APOE genotyped Alzheimer's disease patients. Effects on cognitive performance, brain bioelectrical activity and cerebral perfusion. Methods.Find.Exp.Clin.Pharmacol. ;21(9):633-644. View abstract.

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Citicoline

Common Name(s): CDP-choline, Citicoline, Cytidine 5&#;-diphosphocholine, Cytidine diphosphate-choline

Medically reviewed by Drugs.com. Last updated on Nov 1, .

Clinical Overview

Use

Citicoline has been investigated for the treatment of depression, schizophrenia, stroke, Parkinson disease, brain injury, and cognitive deficits (ie, mild to moderate dementia and Alzheimer disease, cerebrovascular disorders), as well as for its ophthalmologic effects. However, clinical trial results have been inconsistent; therefore, citicoline cannot be recommended for any indication.

Dosing

Oral dosages of 250 to 2,000 mg daily have been evaluated in adolescents and adults in clinical trials. Lower doses (100 mg twice daily) have been used in short-term trials (6 weeks) with combination therapy in patients with major depressive disorder.

Contraindications

Contraindications have not been identified.

Pregnancy/Lactation

Information regarding safety and efficacy in pregnancy and lactation is lacking at dosages above those usually consumed nutritionally.

Interactions

None well documented.

Adverse Reactions

Citicoline was well tolerated in clinical trials. Adverse effects may include GI disturbances, transient headaches, hypotension, tachycardia, bradycardia, and restlessness.

Toxicology

No data.

Source

Citicoline is found in all animal and plant cell membranes. Citicoline is produced endogenously as an intermediate in the production of phosphatidylcholine from choline and is then hydrolyzed in the small intestine to make choline and cytidine available for further biosynthesis.(Nakazaki , Secades ) Citicoline is available commercially in its free-base form or as a sodium salt.(Schauss )

History

Citicoline is widely available internationally as a supplement, which was originally developed in Japan for the treatment of acute cerebrovascular disorders. After introduction in some European markets, use has shifted from treatment of acute to treatment of chronic cerebrovascular disorders, although further research is needed.(Fioravanti )

Chemistry

Citicoline is a phospholipid composed of ribose, pyrophosphate, cytosine, and choline. It is water soluble and highly bioavailable.(Nakazaki , Nashine , Shi )

Uses and Pharmacology

Supplementation with citicoline increases choline stores available for other biosynthetic pathways. Citicoline appears to decrease glutamate levels in the brain and increase adenosine triphosphate, which in turn offers protection against ischemic neurotoxicity. Increased glucose metabolism in the brain and cerebral blood flow has also been demonstrated, as well as increased availability of the neurotransmitters acetylcholine, norepinephrine, and dopamine.(Arenth , Secades )

Antioxidant effects

Animal and in vitro data

Antioxidant effects of citicoline have been demonstrated in several models, including brain, renal, and hepatic injury.(Bian , Buelna-Chontal , Kocaturk , Menku , Zazueta )

CNS effects

Addiction

Clinical data

Studies have investigated a role for citicoline in substance addiction, including in patients with bipolar disorder.(Brown , Licata ) A 12-week, double-blind, parallel-group, randomized, placebo-controlled trial in 130 adults with bipolar disorder and cocaine dependence reported a significant early treatment effect with citicoline (500 mg/day titrated up every 2 weeks to 2,000 mg/day by week 6) compared with placebo.(Brown )

In methamphetamine-dependent adults enrolled in a double-blind, randomized, placebo-controlled trial (N=74), administration of citicoline 1 g orally twice daily for 8 weeks significantly increased the volume of grey matter (ie, left middle frontal gyrus, right hippocampus, left precuneus) compared with baseline (P<0.01 each) and compared with placebo-treated methamphetamine-dependent patients as well as healthy controls. Although cravings for methamphetamine decreased significantly in the citicoline group (P=0.01), the changes were not statistically significantly different from placebo. Citicoline was well tolerated, with 13 adverse events reported compared with 28 events with placebo.(Jeong )

In another double-blind, randomized, placebo-controlled trial in patients with alcohol use syndrome (N=62), effects of a 12-week citicoline regimen on alcohol use and craving and cognitive parameters were explored. No differences were observed between groups regarding number of drinking days, alcohol craving, or cognitive outcome scores. Tolerability was similar between groups.(Brown )

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Cognition

Animal data

Based on animal data, accelerated resynthesis of phospholipids and subsequent protection of cell membranes in the presence of citicoline have been suggested as a possible mechanism of action in treating cognitive impairment. Labeled phospholipid from radioactively labeled citicoline has been shown to cross the blood-brain barrier. In studies in rats with cognitive impairment, improved memory and learning have been demonstrated in older rats and those with induced memory deficits. Citicoline has also demonstrated enhanced learning ability in dogs.(Conant , Fioravanti , García-Cobos ) Limited animal studies suggest that citicoline may counteract the deposition of beta-amyloid involved in Alzheimer disease.(Conant )

Clinical data

A Cochrane meta-analysis of clinical trials (from s to ) found some evidence of supplemental citicoline's positive effect on memory and behavior in the short- to medium-term versus placebo. Effect size for memory measures (n=884) was 0.19 (95% CI, 0.06 to 0.32); measure of positive Global Clinical Impression (n=217) showed an odds ratio (OR) of 8.89 (95% CI, 5.19 to 15.22).(Fioravanti ) The report further suggests that the effect of citicoline (oral or intravenous [IV]) on memory did not appear to depend on the pathogenesis of the cerebral disorder. Trials included in the meta-analysis enrolled participants with mild to moderate dementia and Alzheimer disease, as well as those with cerebrovascular disorders.(Alvarez-Sabín , Fioravanti , Fioravanti ) In the open-label IDEALE Italian study in patients with mild age-related vascular cognitive impairment (N=349), 265 patients received citicoline 1 g daily in 2 divided doses over 9 months. Mini-Mental State Examination scores remained essentially unchanged over time for the treatment arm, while a decline was evident in control patients (no treatment).(Cotroneo ) A placebo-controlled study of 100 patients with age-associated memory impairment used a citicoline dosage of 500 mg daily for 12 weeks. Treated patients significantly improved from baseline to end point in 3 of the 8 outcomes: Spatial Span, Composite Memory, and Feature Match assessments.(Nakazaki ) Another open-label, parallel study of citicoline versus usual treatment was conducted in 347 poststroke patients in Spain. Improved cognitive outcomes (attention, temporal orientation, and executive function) were reported for the citicoline-treated group.(Alvarez-Sabín )

In healthy volunteers (N=40), a 2-week trial of citicoline 500 mg daily showed significant changes compared with placebo in cognitive outcome measures, such as processing time, working memory, and vigilance. Serum malondialdehyde levels, which normally increase during psychomental stimulus, were also reduced compared with placebo.(Al-kuraishy )

Depression

Clinical data

In a randomized, double-blind, placebo-controlled, parallel-group study in patients diagnosed with major depressive disorder (N=50), depression scores improved significantly at 2, 4, and 6 weeks from baseline with 6 weeks of citicoline (100 mg every 12 hours) in combination with citalopram (20 mg/day for 7 days, then 40 mg/day) compared with citalopram alone (P<0.03, P=0.032, and P=0.021, respectively). Additionally, a significant difference in the "depressed mood" item of the Hamilton Depression Rating Scale was observed between the 2 groups at the end of the trial (P=0.04). Remission rate was also significantly greater with citicoline combination therapy (72%) compared with citalopram only (44%) (P=0.045). No significant differences were noted in adverse events between groups.(Roohi-Azizi )

Epilepsy

Animal data

In 2 organophosphate-induced seizure rat models, administration of citicoline did not demonstrate anticonvulsant or neuroprotective effects.(Barker )

Head injury

Animal data

Antioxidant and anti-inflammatory mechanisms of citicoline have been evaluated in experimental studies of rats with head injury.(Bian , Menku )

Clinical data

A systematic review of the effects of cholinomimetic agents on head injury included trials and case reports using citicoline, all with some limitations in methodology (eg, small sample size, single blinding).(Poole ) Positive findings have been reported in these studies; however, in the larger Citicoline Brain Injury Treatment Trial published in , a 90-day regimen of enteral or oral citicoline 2,000 mg daily did not result in improvement in functional and cognitive status versus placebo (global OR, 0.87 [95% CI, 0.72 to 1.04]).(Zafonte )

Neuroprotective effects

Clinical data

Hospitalized children (N=80) who had experienced cardiac arrest were treated with citicoline 10 mg/kg added to conventional therapy for 6 weeks or conventional therapy alone. Patients in the citicoline group had improved Glascow coma and disability scores and reduced seizure frequency and duration, as well as shorter pediatric intensive care unit stays and a lower mortality rate compared with the conventional therapy group.(Salamah )

Parkinson disease

Clinical data

A systematic review of literature published through evaluated citicoline as an adjuvant to levodopa therapy in adults with Parkinson disease. The 7 included studies were randomized controlled (n=3), crossover (n=2), and open-label prospective (n=2). The studies enrolled a total of 335 patients (individual study range, 10 to 85 patients) 31 to 82 years of age. Duration of disease ranged from 1 month to 30 years, and disease severity encompassed all stages. Overall, results suggested that the addition of citicoline to levodopa may offer benefit over levodopa alone, including up to a 50% reduction in levodopa dose noted by 2 studies and significant improvement in global and/or individual symptoms (eg, rigidity, akinesia, motor tasks, balancing upper extremities, speech) documented in all 7 studies.(Que )

Psychomotor function

Clinical data

Attention and psychomotor speed (of the dominant hand) improved significantly in 75 healthy adolescent males (13 to 18 years of age) after 28 days of supplementation with citicoline 250 mg/day or 500 mg/day compared with placebo in a randomized, double-blind trial. Higher weight-adjusted doses were associated with greater improvements in accuracy, signal detectability, and commission errors.(McGlade )

Schizophrenia

Clinical data

In an 8-week double-blind, randomized, placebo-controlled trial in 73 patients with stable schizophrenia, adjunctive use of citicoline with risperidone significantly improved mean negative symptom scores (on Positive and Negative Syndrome Scale [PANSS]) compared with placebo plus risperidone (adjusted P=0.013). Patients in the citicoline group experienced a significantly (both statistically and clinically) greater reduction (11%) from baseline in PANSS negative subscale score compared with those receiving placebo. General psychopathology (P=0.013) and total PANSS scores (P<0.001) were also better in the citicoline group. Scores for positive symptoms, extrapyramidal symptoms, and depression remained similar between treatment groups. No significant difference in frequency of adverse events was observed between the groups.(Ghajar )

Citicoline's effects in schizophrenia may be related to improvements in sensory processing associated with impact on the alpha7 nicotinic acetylcholine receptor system.(Aidelbaum )

Tremor/ataxia syndrome

Clinical data

An open-label phase 2 pilot study explored the safety and efficacy of citicoline in 10 patients with fragile X-associated tremor/ataxia syndrome, specifically in terms of motor and cognitive function. Overall, citicoline 1,000 mg/day for 12 months did not significantly improve the severity of motor signs, and results were inconclusive regarding whether improvements in cognitive scores and anxiety were due to study medication. Citicoline was safe and well tolerated in this small patient population.(Hall )

Endotoxic shock

Animal data

In a study of mongrel dogs, administration of citicoline reduced or blocked endotoxin-induced changes in blood pressure (P<0.001), heart rate (P<0.001), echocardiographic parameters, cardiac injury markers, respiratory rate, PO2, pH (P<0.001), and bicarbonate versus baseline, without altering sinus cardiac rhythm. Additionally, citicoline suppressed endotoxin-induced increases in tumor necrosis factor alpha and nitric oxide but also enhanced catecholamine levels in both control and endotoxin-treated animals.(Kocaturk )

Hepatoprotective effects

Animal data

In mice, citicoline provided hepatoprotective effects against ischemic-reperfusion liver damage via preservation of mitochondrial function and a reduction in oxidative stress, but did not show an effect on inflammatory mediators.(Zazueta )

Ophthalmologic effects

Animal data

Studies in animals suggest that citicoline stimulates dopamine in the retina.(Grieb ) In rats with chronically elevated intraocular pressure (IOP), oral citicoline treatment (500 mg/kg) was associated with reduced degradation of visual acuity and "visual brain integrity loss" without lowering IOP, suggesting neurological benefits beyond IOP control.(van der Merwe )

Clinical data

An 8-year follow-up of patients with glaucoma who were included in an earlier trial showed improvement in retinal and visual function.(Parisi ) An open-label study showed similar effects following 2 weeks of treatment with oral citicoline 1 g daily.(Saver ) In patients with mild to moderate progressive open-angle glaucoma (IOP <18 mm Hg) enrolled in a double-blind, randomized, placebo-controlled study (N=80), topical citicoline application for 3 years did not significantly reduce the 3-year progression rate compared with placebo (&#;1.03 dB vs &#;1.92 dB, respectively) based on the 24-2 standard strategy assessment. In contrast, significant improvement in visual field progression was observed with citicoline compared with placebo using the 10-2 strategy assessment (3-year progression rate, &#;0.41 dB vs &#;2.22 dB, respectively; P=0.02). The rate of retinal nerve fiber layer loss was also significantly less on average at year 3 with citicoline eye drops (&#;1.86 mcm) compared with placebo (&#;2.99 mcm) (P=0.02). Humphrey field analyzer mean deviation progression was significantly associated with age but not IOP. Citicoline eye drops were well tolerated, and no local or systemic adverse events were reported.(Rossetti )

In a single-blind, randomized, prospective pilot study of adults with nonarteritic anterior ischemic optic neuropathy (NAION) (N=60), 6-month administration of oral citicoline solution significantly improved functional and morphological parameters (P<0.01 each) compared with no treatment. Improvements were significantly and positively correlated with greater impairment at baseline (P<0.01 each). Additionally, visual acuity was significantly better in the citicoline group, with only 5.27% of eyes experiencing a reduction in visual acuity at month 6 compared with 29.41% of eyes in the untreated group (P<0.01). After a 3-month citicoline washout period, significant improvements were maintained for all 3 assessments in treated compared with untreated controls (P<0.01 for all) at month 9. Reduced visual acuity was still present in only 5.26% of eyes previously treated with citicoline compared with 41.18% of eyes in the untreated group. No adverse events were reported in either group.(Parisi )

Based on success with citicoline treatment in adult patients with amblyopia, researchers performed a retrospective study evaluating success rates in pediatric patients treated with citicoline for refractive amblyopia. All eyes showed clinical improvement in visual acuity after 3 to 6 months of treatment, but only eyes with mild or moderate amblyopia reached statistically significant improvement.(Loebis )

In a prospective, controlled study in 78 patients who underwent LASIK surgery, post-LASIK treatment with either conventional lubricant (hyaluronic acid 15% eye drops) or citicoline eye drops was compared. Corneal sensitivity measurements were significantly better with citicoline at postsurgical weeks 1, 2, 3, 4, and 6; measurements were not significantly different between groups at weeks 8 and 12.(Cinar )

Renal dysfunction

Animal data

Citicoline offered nephroprotection against mercury-induced renal damage in rats, specifically via preservation of calcium accumulation in the renal mitochondria. This allowed for continued transmembrane potential and adenosine triphosphate production. Reductions in oxidative stress were also reported, including lower interleukin 1 (IL-1) and IL-6 levels.(Buelna-Chontal )

Respiratory distress syndrome

Animal data

In mice infected with an acutely lethal dose of H1N1 influenza A virus, administration of citicoline within 4 days postinoculation significantly reduced hypoxemia, bradycardia, pulmonary edema, and bronchoalveolar lavage fluid protein levels. Static lung compliance and alveolar fluid clearance rates were also restored to normal.(Rosas )

Stroke

Animal data

Positive findings with citicoline have been reported in experiments using rats with induced cerebral insufficiency and models of hypoxia.(Clark , Hurtado )

Clinical data

A meta-analysis of pooled individual results from studies evaluating adjunctive use of citicoline 500 to 2,000 mg/day in moderate to severe acute ischemic stroke showed a positive OR of 1.33 (95% CI, 1.1 to 1.62) for citicoline.(Saver ) Further reviews of citicoline treatment following ischemic stroke have also suggested improved outcomes, including complete recovery, at 3 months.(Adibhatla , Adibhatla , Clark , Conant , Overgaard ) However, in a meta-analysis of randomized controlled trials (published up to May ) in which citicoline was administered within 24 hours of acute ischemic (n=6 studies) or hemorrhagic (n=1 study) stroke, no significant difference was found between citicoline and controls regarding mortality, outcome dependency, effectiveness, or safety. Citicoline dosing in the 7 studies (N=4,039) ranged from 500 to 2,000 mg/day given for a minimum of 3 months.(Shi )

Findings from the large multicenter ICTUS study in ischemic stroke patients (N=2,298; conducted between and ) using citicoline 1 g IV every 12 hours for 3 days, then orally for 6 weeks have been published. Using a global score combining the National Institutes of Health Stroke Scale, modified Rankin score, and Barthel Index, no significant difference at 90 days between citicoline and placebo was observed (OR, 1.03 [95% CI, 0.86 to 1.25]; P=0.364). Similarly, there were no significant differences regarding adverse events.(Dávalos )

A Cochrane review of citicoline use in acute ischemic stroke (10 studies) concluded that there may be "little or no difference" in mortality, disability reduction, cardiovascular adverse events, or physical recovery for citicoline treatment compared with placebo.(Martí-Carvajal ) A placebo-controlled study evaluating citicoline 1 g twice daily in patients undergoing recanalization after acute ischemic stroke showed no difference from placebo in clinical outcomes at 3 months.(Agarwal ) A study of conventional therapy alone versus conventional therapy plus citicoline 1 g daily showed no differences in clinical outcomes at 8 weeks, but did note an improvement in short-interval intracortical inhibition in the citicoline group compared with placebo.(Premi )

Dosing

In clinical studies evaluating various neurological effects of citicoline, oral dosages ranged from 250 to 2,000 mg daily; treatment durations varied.(Brown , Cotroneo , McGlade , Nakazaki ) Citicoline 100 mg every 12 hours was used in combination with citalopram for 6 weeks in a study of patients with major depressive disorder.(Roohi-Azizi , Sarkar )

Citicoline is water-soluble and highly bioavailable, with very little drug excreted in the feces.(Dávalos ) Citicoline exhibits biphasic plasma peak concentrations at 1 and 24 hours, as well as biphasic elimination.(Sarkar )

Pregnancy / Lactation

Information regarding safety and efficacy in pregnancy and lactation is lacking at dosages above those usually consumed nutritionally. The effects of citicoline have been studied in rats during pregnancy for a potential role in the protection of dendrites in the cortex and fetal lung development, as well as in pregnant individuals during the third trimester. However, information is limited regarding the safety of supplemental citicoline.(Rema , Yan )

Interactions

None well documented.(Secades ) Animal data indicate synergism between citicoline and imipramine; a pharmacodynamic interaction may be possible.(Khakpai )

Adverse Reactions

Citicoline was well tolerated in clinical trials.(Fioravanti ) Adverse effects may include GI disturbances, transient headaches, hypotension, tachycardia, bradycardia, and restlessness.(Cho , Cotroneo , Dávalos , Secades )

Citicoline may exacerbate adrenocorticotropic hormone&#; or cortisol hypersecretion&#;related disorders, including type 2 diabetes and major depressive disorder.(Cavun )

Toxicology

Clinical data regarding toxicity are limited. The IV median lethal dose in rodents was suggested to be approximately 4 g/kg. A 30-day study in rats found no toxicity at 150 mg/kg/day. In dogs given oral citicoline 1.5 g/kg daily for 6 months, no biochemical, neurological, or histological toxicity was found.(Schauss )

References

Disclaimer

This information relates to an herbal, vitamin, mineral or other dietary supplement. This product has not been reviewed by the FDA to determine whether it is safe or effective and is not subject to the quality standards and safety information collection standards that are applicable to most prescription drugs. This information should not be used to decide whether or not to take this product. This information does not endorse this product as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this product. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this product. This information is not specific medical advice and does not replace information you receive from your health care provider. You should talk with your health care provider for complete information about the risks and benefits of using this product.

This product may adversely interact with certain health and medical conditions, other prescription and over-the-counter drugs, foods, or other dietary supplements. This product may be unsafe when used before surgery or other medical procedures. It is important to fully inform your doctor about the herbal, vitamins, mineral or any other supplements you are taking before any kind of surgery or medical procedure. With the exception of certain products that are generally recognized as safe in normal quantities, including use of folic acid and prenatal vitamins during pregnancy, this product has not been sufficiently studied to determine whether it is safe to use during pregnancy or nursing or by persons younger than 2 years of age.

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