Citicoline for Cognitive Performance

Recruiting at 1 trial location

Overseen by Kathleen Kelley, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Kirin Holdings Company, Limited

Disqualifiers: Pregnancy, Psychiatric disorders, Diabetes, others

Trial Summary

What is the purpose of this trial?

This trial tests if citicoline, a brain-boosting supplement, can improve attention in healthy men and women by increasing important brain chemicals. Citicoline is a naturally occurring compound that has shown beneficial effects on memory function and behavior in various populations with cognitive impairments.

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.

What evidence supports the effectiveness of the treatment Citicoline supplement for cognitive performance?

Research shows that citicoline can improve attention and motor speed in adolescents, enhance verbal memory in older adults, and may prevent cognitive decline in patients with cerebrovascular disease. This suggests it could be beneficial for cognitive performance. ^{1 2 3 4 5}

Is citicoline safe for human use?

Citicoline is generally considered safe for human use, with studies indicating a favorable side effect profile when used as a supplement. It has been researched in various conditions, including cognitive decline and alcohol use disorder, without significant safety concerns. ^{2 3 6 7 8}

How does the drug citicoline differ from other treatments for cognitive performance?

Citicoline is unique because it is a dietary supplement that enhances cognitive function by influencing neurotransmitter systems and supporting neuronal membrane integrity, which may help with memory and cognitive performance. Unlike other treatments, it is an endogenous compound that can easily cross the blood-brain barrier and has been used for various neurological disorders, including Alzheimer's disease and stroke. ^{2 6 7 9 10}

Research Team

Kathleen Kelley, MD

Principal Investigator

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

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Citicoline supplement (N/A)
• Placebo supplement (N/A)

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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 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]

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]

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 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]

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]

References

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

The Effect of Citicoline Supplementation on Motor Speed and Attention in Adolescent Males. [2020]

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

Citicoline improves verbal memory in aging. [2019]

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

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

4. England 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. [2019]

5. 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]

6. 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]

7. Iran pubmed.ncbi.nlm.nih.gov

Citicoline Improves Human Vigilance and Visual Working Memory: The Role of Neuronal Activation and Oxidative Stress. [2022]

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

A Randomized, Double-Blind, Placebo-Controlled Trial of Citicoline in Patients with Alcohol Use Disorder. [2020]

9. Spain 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. [2013]

10. England pubmed.ncbi.nlm.nih.gov

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