Citicoline for Cognitive Performance

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Kirin Holdings Company, Limited

Disqualifiers: Pregnancy, Psychiatric disorders, Diabetes, Cardiovascular disease, Cancer, 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 explores whether Cognizin, a form of citicoline, can boost brain energy and protect brain cells, potentially improving brain function in healthy adults. Participants will receive either Cognizin or a placebo (a substance with no active ingredients) to compare the effects. The trial seeks healthy adults who regularly eat breakfast and can swallow capsules. This trial offers a valuable opportunity for individuals interested in contributing to research on enhancing cognitive performance. As an unphased trial, it provides a unique chance to contribute to foundational research on cognitive enhancement.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using treatments for psychiatric disorders, brain-related conditions, or have any medical condition that might interfere with the study, you may not be eligible to participate.

Is there any evidence suggesting that Citicoline (Cognizin) is likely to be safe for humans?

Research has shown that citicoline, the main ingredient in Cognizin, is generally safe for most people. It has proven effective and safe for improving mild memory and thinking problems related to blood flow issues. When taken orally for up to 12 weeks, citicoline is likely safe. Some individuals might experience mild side effects, such as stomach or back pain, blurred vision, or constipation. Overall, citicoline is well-tolerated, and serious side effects are rare. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard cognitive enhancers that primarily focus on stimulating neurotransmitter release, Citicoline (Cognizin) is unique because it supplies the brain with cytidine and choline, which are crucial for building cell membranes and enhancing brain function. This novel mechanism supports overall brain health and cognitive performance, rather than just temporarily boosting neurotransmitter levels. Researchers are excited about Citicoline because it has shown potential to improve attention, memory, and mental energy without the jittery side effects often associated with traditional stimulants.

What evidence suggests that Citicoline (Cognizin) might be an effective treatment for cognitive performance?

Research has shown that citicoline, particularly in its special form called Cognizin, can improve memory. In studies with healthy older adults, taking citicoline for 12 weeks enhanced memory, especially the ability to recall specific events. Another study found similar improvements in both men and women with age-related memory issues. In this trial, participants will receive either Cognizin® or a placebo to evaluate its effects on cognitive performance. While citicoline can help with memory problems, it might not enhance normal brain functions. Overall, these findings suggest that citicoline could support brain health and memory. ^{4 6 7 8 9}

Who Is on the Research Team?

Dr.Koichiro Murashima

Principal Investigator

Kirin Holding Company Ltd. - Institute of Health Sciences

Are You a Good Fit for This Trial?

Healthy adults aged 18-35 with a BMI of 18.0 to 34.9 kg/m2, who eat breakfast regularly and maintain consistent caffeine habits. Participants must be in good health, able to swallow capsules, have an MMSE score >24, and can't use nicotine or have significant alcohol intake. Excludes those with allergies to study products, recent substance abuse history, certain medical conditions or treatments.

Inclusion Criteria

Participants who habitually eat breakfast and agree to eat breakfast daily, and take study product with this meal when applicable

Participants agree to maintain their usual caffeine consumption habits

Body mass index (BMI) between 18.0 to 34.9 kg/m2

Exclusion Criteria

Known sensitivity, intolerability, or allergy to any of the study products or their excipients

Participants who habitually used any nicotine-containing products in the past 6 months before screening

Individuals with any pre-existing neuromuscular disorder, physical disability, or injury

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Cognizin or placebo and their cognitive performance is assessed using the Psychomotor Vigilance Test (PVT) at baseline and after 12 weeks

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 (Cognizin)

Trial Overview The trial is testing Cognizin®, a patented form of citicoline thought to enhance brain function by increasing energy and protecting cells. It's compared against a placebo to see if it improves cognitive performance in healthy adults when taken with breakfast.

How Is the Trial Designed?

Group I: Cognizin® Active Control 1 Intervention

Active ingredients: Citicoline

Group II: Placebo Placebo Group 1 Intervention

Active ingredients: none

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+

Published Research Related to This Trial

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]

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-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 involving 12 healthy adult volunteers, CDP-choline (citicoline) was administered in two different doses (600 mg and 1 g per day) over 5 days, showing that it is generally well-tolerated with minimal side effects.

The only reported adverse effects were transient headaches in a few participants, indicating that CDP-choline has a favorable safety profile compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CDP-choline: repeated oral dose tolerance studies in adult healthy volunteers. Dinsdale, JR., Griffiths, GK., Castelló, J., et al.[2013]

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]

The study assessed the acute toxicity of a single dose of CDP-choline (citicoline) in mice and rats, determining the lethal dose (LD50) values to understand its safety profile.

Different administration routes were evaluated, providing insights into how the method of delivery may affect the toxicity of CDP-choline, which is important for its therapeutic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CDP-choline: acute toxicity study. Grau, T., Romero, A., Sacristán, A., et al.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8349115/

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.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2475299123092454

Effect of Citicoline on Memory Function in Healthy Order ... Dietary supplement of Cognizin® for 12 weeks improved overall memory performance, especially episodic memory, in healthy males and females with AAMI.

3. 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 ...

4. 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 ...

5. 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 ( ...

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. mindlabpro.com mindlabpro.com/blogs/nootropics/citicoline?srsltid=AfmBOorCDVJf_8ZYx33tCvvS2U-NsyjDrGG7_CwR14ORgaLo7Yy-ymFN

Citicoline: Cognizin Benefits, Dosage, Side Effects, and More Citicoline is a brain supplement (also known as a nootropic) linked to multiple cognition-enhancing effects in human randomized controlled trials.

8. 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 ...

9. synapse.patsnap.com synapse.patsnap.com/article/what-are-the-side-effects-of-citicoline

What are the side effects of Citicoline? While citicoline is generally considered safe for most people, like any supplement or medication, it can have side effects. Understanding these ...