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

90 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Citicoline (Cognizin) for cognitive performance?

Research shows that Citicoline can help improve memory and other mental functions in people with mild cognitive impairment and those with cerebrovascular diseases, which affect blood flow in the brain. It has also been beneficial in maintaining cognitive function in Alzheimer's patients when used with other treatments. ^{1 2 3 4 5}

Is citicoline safe for human use?

Citicoline is generally considered safe for human use. In studies with healthy volunteers, only mild side effects like transient headaches were reported. It has been used in various conditions, including cognitive decline and stroke, with no major safety concerns. ^{6 7 8 9 10}

How is the drug citicoline unique for cognitive performance?

Citicoline is unique because it acts as a neuroprotective agent, influencing important brain chemicals like acetylcholine, dopamine, and glutamate, which are involved in memory and attention. It also helps maintain the structure and function of brain cell membranes, which may aid in repairing them, making it different from other treatments that might not target these specific mechanisms. ^{1 3 7 8 11}

What is the purpose of this trial?

Cognizin is a patented form of citicoline, a natural compound of the brain tissue. It is believed that Cognizin can support brain function by boosting brain energy and protecting brain cells. Research suggests that Cognizin can improve different aspects of brain function and affects cognitive performance in healthy adults.

Research Team

Dr.Koichiro Murashima

Principal Investigator

Kirin Holding Company Ltd. - Institute of Health Sciences

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[A multicenter observation study of the efficacy of cortexin and recognan (citicoline) in the treatment of cognitive impairments in chronic cerebrovascular pathology]. [2019]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Citicoline May Prevent Cognitive Decline in Patients with Cerebrovascular Disease. [2023]

3. Russia (Federation) 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]. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A Retrospective Study on the Benefits of Combined Citicoline, Memantine, and Acetylcholinesterase Inhibitor Treatments in Older Patients Affected with Alzheimer's Disease. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Citicoline (Cognizin) in the treatment of cognitive impairment. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

CDP-choline: acute toxicity study. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

Citicoline in addictive disorders: a review of the literature. [2021]

9. New Zealand pubmed.ncbi.nlm.nih.gov

The role of citicoline in cognitive impairment: pharmacological characteristics, possible advantages, and doubts for an old drug with new perspectives. [2018]

10. Germany pubmed.ncbi.nlm.nih.gov

CDP-choline: repeated oral dose tolerance studies in adult healthy volunteers. [2013]

11. England pubmed.ncbi.nlm.nih.gov

Citicoline. Ferrer Internacional. [2013]