Citicoline for Cognitive Performance

No longer recruiting at 1 trial location

Overseen By Stephanie Recker

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kirin Holdings Company, Limited

Disqualifiers: Pregnancy, Psychiatric disorders, Diabetes, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a supplement called citicoline can improve attention and cognitive performance. Participants will be divided into two groups: one taking the citicoline supplement and the other taking a placebo (a pill with no active ingredients) for comparison. The trial seeks men and women who feel they have poor attention but are otherwise healthy. Participants should not have color blindness or any major illnesses. The goal is to determine if citicoline can help with focus and attention in everyday life. As an unphased trial, this study offers participants the chance to contribute to understanding how citicoline might enhance cognitive function.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if your medications or supplements might affect your ability to participate, the study investigator will decide if you can join the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that citicoline is generally safe for use. Studies have found it effective and safe for improving mild memory and thinking problems. One study found that people taking citicoline experienced improvements without serious side effects. Another report supports these findings, noting that while some side effects like stomach pain or blurred vision might occur, they are uncommon. Overall, most people can use citicoline without problems for short periods, such as up to 12 weeks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard cognitive performance enhancers, which often include stimulants like caffeine or prescription medications, Citicoline is a naturally occurring compound that supports brain health. Researchers are excited about Citicoline because it plays a key role in producing phosphatidylcholine, an essential component of brain cell membranes. This means it might help protect and repair neurons, potentially improving memory and cognitive function. Additionally, Citicoline is known for being well-tolerated with minimal side effects, making it an attractive alternative to existing options.

What evidence suggests that citicoline might be an effective treatment for cognitive performance?

Research has shown that citicoline might improve memory and thinking skills, especially in certain groups. For example, one study found that taking citicoline for 12 weeks improved memory, particularly the ability to remember specific events, in healthy older adults. Another study demonstrated that citicoline helps people with memory and thinking problems achieve better results. However, while citicoline often aids with memory issues, it does not always enhance normal thinking skills in healthy individuals. This trial will compare the effects of a citicoline supplement with a placebo supplement to evaluate its potential for improving attention and thinking abilities. ^{4 6 7 8 9}

Who Is on the Research Team?

Kathleen Kelley, MD

Principal Investigator

Biofortis Clinical Research, Inc. Addison, Illinois, United States, 60101

Are You a Good Fit for This Trial?

This trial is for healthy men and women aged 35-75 who feel they have poor attention. They must score well on mental state and depression tests, not be color blind, or pregnant, and can't have ADHD or major illnesses that could interfere with the study.

Inclusion Criteria

You have trouble paying attention, as reported by yourself.

no health conditions that would prevent him or her from fulfilling the study requirements on the basis of medical history and routine laboratory test results

You should have a good memory and not be experiencing depression or cognitive issues.

Exclusion Criteria

I have been diagnosed with ADHD.

You have a serious medical or neurological condition.

I am not on medication that could interfere with the study treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either citicoline or placebo for cognitive performance assessment

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Citicoline supplement
• Placebo supplement

Trial Overview

The trial is testing Citicoline (Cognizin®) against a placebo to see if it improves attention in healthy adults. Participants will take either the supplement or a placebo without knowing which one they're getting.

How Is the Trial Designed?

Group I: Cognizin® Experimental Treatment 1 Intervention

Intervention: Dietary Supplement: Citicoline supplement

Group II: Placebo Placebo Group 1 Intervention

Intervention: Dietary Supplement: Placebo supplement

Who Is Running the Clinical Trial?

Kirin Holdings Company, Limited

Lead Sponsor

Trials

5

Recruited

1,000+

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Collaborator

Trials

40

Recruited

2,400+

Biofortis Clinical Research, Inc.

Industry Sponsor

Trials

12

Recruited

1,000+

Published Research Related to This Trial

In a study of 75 healthy adolescent males, those who took citicoline for 28 days showed significant improvements in attention and psychomotor speed compared to those on a placebo.

Higher doses of citicoline were linked to better accuracy in attention tasks and reduced impulsivity, suggesting that citicoline may enhance cognitive function in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Citicoline Supplementation on Motor Speed and Attention in Adolescent Males. McGlade, E., Agoston, AM., DiMuzio, J., et al.[2020]

In a 12-month study involving 81 participants aged 50-75 with subjective cognitive complaints (SCC) and mild cognitive impairment (MCI), citicoline treatment led to significant improvements in cognitive performance, particularly in language, attention, and memory domains.

The presence of the APOE-ε4 gene did not affect the cognitive improvements observed, suggesting that citicoline may be beneficial for cognitive health regardless of genetic risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Citicoline May Prevent Cognitive Decline in Patients with Cerebrovascular Disease. Almeria, M., Alvarez, I., Molina-Seguin, J., et al.[2023]

In a study of 54 patients with mild cognitive impairment, treatment with the drug Recognan (citicoline) for 30 days led to significant improvements in various cognitive functions, including memory (58.3% improvement), concentration (64% improvement), and visual-motor coordination (86.4% improvement).

The results indicate that Recognan has a complex positive effect on higher mental functions, with notable enhancements in cognitive abilities observed as early as 2 weeks into the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effect of the use of the drug recognan (citicoline) on the state of higher mental functions in patients with mild cognitive impairment]. Nemkova, SA., Semenov, DV., Petrova, EA., et al.[2022]

In a study involving 40 healthy volunteers, citicoline significantly improved psychomotor vigilance and visual working memory compared to a placebo, indicating its efficacy in enhancing cognitive functions.

Citicoline also reduced oxidative stress by significantly lowering serum levels of Malondialdehyde (MDA), while the placebo increased MDA levels, suggesting a protective effect against oxidative damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Citicoline Improves Human Vigilance and Visual Working Memory: The Role of Neuronal Activation and Oxidative Stress. Al-Kuraishy, HM., Al-Gareeb, AI.[2022]

Citicoline is a safe and well-tolerated dietary supplement that shows promise in reducing cravings and cocaine use, particularly at high doses in patients with cocaine dependence and bipolar disorder, based on a review of nine clinical studies.

While most research focuses on cocaine addiction, there is potential for citicoline to also benefit those with alcohol and cannabis dependence, indicating a need for further studies with larger sample sizes and more complex designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Citicoline in addictive disorders: a review of the literature. Wignall, ND., Brown, ES.[2021]

In a 12-week pilot study involving 62 adults with alcohol use disorder, citicoline was found to be well tolerated but did not significantly reduce alcohol use, cravings, or depressive symptoms compared to a placebo.

Despite previous positive effects of citicoline in other conditions, this study suggests that it may not be effective for treating alcohol use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized, Double-Blind, Placebo-Controlled Trial of Citicoline in Patients with Alcohol Use Disorder. Brown, ES., Van Enkevort, E., Kulikova, A., et al.[2020]

In a study involving 95 older volunteers, citicoline at a dosage of 1000 mg/d improved verbal memory in individuals with relatively inefficient memories, suggesting its potential as a cognitive enhancer.

A follow-up crossover study with a higher dosage of 2000 mg/d further demonstrated that citicoline significantly improved both immediate and delayed verbal memory, indicating its efficacy in addressing age-related cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Citicoline improves verbal memory in aging. Spiers, PA., Myers, D., Hochanadel, GS., et al.[2019]

In a study of 30 Alzheimer's patients, treatment with 1,000 mg/day of citicoline for 12 weeks significantly improved cognitive performance compared to placebo, especially in patients with mild dementia and those carrying the APOE E4 allele.

Citicoline was well tolerated with no adverse side effects, and it also increased cerebral blood flow and altered brain bioelectrical activity, suggesting it may be a beneficial treatment for Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double-blind placebo-controlled study with citicoline in APOE genotyped Alzheimer's disease patients. Effects on cognitive performance, brain bioelectrical activity and cerebral perfusion. Alvarez, XA., Mouzo, R., Pichel, V., et al.[2013]

A systematic review of 25 studies involving older adults (mean age ≥65 years) found that while some B-vitamin supplements showed cognitive benefits, the overall evidence for nutraceuticals improving cognition is not compelling, with only five studies demonstrating notable effects.

Specifically, B-vitamins were linked to improved cognitive function in certain populations, such as those with high homocysteine levels or higher baseline n-3 fatty acid status, but more research is needed to explore interactions with lifestyle and genetic factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of long-term nutraceutical and dietary supplement use on cognition in the elderly: a 10-year systematic review of randomised controlled trials. D'Cunha, NM., Georgousopoulou, EN., Dadigamuwage, L., et al.[2019]

Citicoline shows potential clinical benefits for elderly patients with cognitive deficits and early-stage Alzheimer's disease, acting as a choline donor that supports the production of acetylcholine and neuronal membrane components.

Research indicates that citicoline has cholinergic and neuroprotective effects, which may help improve neuronal membrane integrity and functionality, although its efficacy in stroke patients remains inconclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic applications of citicoline for stroke and cognitive dysfunction in the elderly: a review of the literature. Conant, R., Schauss, AG.[2013]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2695184/

Citicoline (Cognizin) in the treatment of cognitive impairment

Most of these studies have shown that treatment with citicoline ameliorates cognitive deficits but does not necessarily improve normal cognitive functions ( ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S002231662200267X

Citicoline and Memory Function in Healthy Older Adults

Dietary supplementation of citicoline for 12 wk improved overall memory performance, especially episodic memory, in healthy older males and females with AAMI.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06890962

NCT06890962 | Citicoline Dose on Energy Drink Efficacy

The purpose of this study is to determine how the doses of cognitive-enhancing ingredients such as citicoline and caffeine effect the efficacy of acute ...

4.

efsa.onlinelibrary.wiley.com

efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2024.8861

'Citicoline' and support of the memory function: Evaluation of a ...

Double-blind placebo-controlled study with citicoline in APOE genotyped Alzheimer's disease patients. Effects on cognitive performance, brain ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4562749/

The role of citicoline in cognitive impairment - PubMed Central

Moreover, citicoline group showed a better functional outcome (modified Rankin scale ≤2) at 12 months (57.3% vs 48.7%) without statistically significant ...

6.

webmd.com

webmd.com/vitamins/ai/ingredientmono-1090/citicoline

Citicoline - Uses, Side Effects, and More

When taken by mouth: Citicoline is possibly safe when used for up to 12 weeks. Side effects might include stomach pain, back pain, blurred vision, constipation, ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3569046/

Effectiveness and safety of citicoline in mild vascular cognitive ...

This study shows that citicoline is effective and safe in the treatment of mild vascular cognitive impairment. The treated group showed improvement in MMSE ...

8.

alzdiscovery.org

alzdiscovery.org/uploads/cognitive_vitality_media/Citicoline-CDP-choline-Cognitive-Vitality-For-Researchers.pdf

Citicoline (CDP-choline)

In addition, these reports include evaluation of safety data, from clinical trials if available, and from preclinical models. Citicoline (CDP-choline).

9.

mindlabpro.com

mindlabpro.com/blogs/nootropics/citicoline?srsltid=AfmBOoqQAeCoKPJFvJVZphCetdI-Xc2I9dZ7jl8pid7ukttfnroBBTXE

Citicoline: Cognizin Benefits, Dosage, Side Effects, and More

Backed by decades of research and the advanced science of the branded form Cognizin®, it is both safe and highly effective, with human trials showing benefits ...