Citicoline Supplement for Mild Cognitive Impairment

Recruiting at 1 trial location

Overseen By Victoria Pak, PhD, MS, MTR

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must not be taking: REM sleep medications, Choline supplements

Disqualifiers: Epilepsy, Cardiac insufficiency, Diabetes, others

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing whether a citicoline supplement can help people with mild cognitive impairment (MCI). Citicoline may improve brain function by increasing important brain chemicals. Researchers will also check if it affects sleep and markers related to Alzheimer's disease. Citicoline has been studied for its potential benefits in cognitive decline, including Alzheimer's disease and vascular cognitive impairment.

Will I have to stop taking my current medications?

You may need to stop taking any medication that affects REM sleep or sleep patterns, as the trial excludes participants on such medications. If you're taking choline supplements, you will also need to stop those.

Is citicoline safe for humans?

Citicoline is generally considered safe and well-tolerated in humans, with studies showing no severe adverse events even with long-term use. ^{1 2 3 4 5}

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

Citicoline is unique because it is a natural compound that supports brain health by helping to build cell membranes and increase levels of acetylcholine, a chemical important for memory. Unlike some other treatments, it is well-tolerated, has neuroprotective properties, and is marketed as a dietary supplement, making it accessible for long-term use. ^{1 2 3 6 7}

What data supports the effectiveness of the drug citicoline supplement for mild cognitive impairment?

Research shows that citicoline, a drug made from natural molecules, can improve cognitive function in people with mild cognitive impairment, especially when it's related to blood vessel issues. It has also been found to help with other brain-related conditions like Alzheimer's and stroke, and is considered safe and well-tolerated. ^{1 2 3 5 8}

Who Is on the Research Team?

Victoria Pak, PhD, MS, MTR

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for people aged 60 or older with Mild Cognitive Impairment (MCI) who have trouble sleeping, as shown by specific sleep quality scores. Participants must speak English and have internet access. It's not for those on certain medications, using choline supplements, with a history of severe head trauma or epilepsy, allergies to Citicoline ingredients, serious health conditions like heart failure or diabetes, psychiatric disorders, sleep apnea, restless legs syndrome or irregular work schedules.

Inclusion Criteria

I am 60 years old or older.

Your sleep quality score is too high, or you feel excessively sleepy during the day.

Ability to read and understand English

Exclusion Criteria

You have a history of being dependent on alcohol or abusing drugs.

You work at night or have irregular work hours.

I am on medication that affects my sleep patterns.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Baseline data collection including AD biomarkers, sleep assessments, and cognitive evaluations

1-2 weeks

1 visit (in-person)

Treatment

Participants receive dietary citicoline or placebo supplements

12 weeks

Regular check-ins (virtual or in-person)

Follow-up

Participants are monitored for changes in AD biomarkers, sleep, and cognition

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Citicoline Supplement
• Placebo

Trial Overview The study tests if a dietary supplement called citicoline can improve sleep and cognitive function in individuals with MCI. Researchers will also check if it affects Alzheimer's biomarkers in the body. Participants will either receive the citicoline supplement or a placebo without knowing which one they are taking.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

Participants with MCI will receive dietary citicoline supplements.

Group II: Placebo Placebo Group 1 Intervention

Participants with MCI will receive a placebo supplement.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

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]

Citicoline (CDP-Choline) has been shown to improve cognitive function in patients with mild cognitive impairment (MCI), particularly those with vascular origins, based on a review of existing literature.

Long-term use of citicoline is well-tolerated and safe, with no severe adverse events reported, highlighting its potential as a neuroprotective treatment for various cognitive impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Citicoline in Patients With Mild Cognitive Impairment. Bermejo, PE., Dorado, R., Zea-Sevilla, MA.[2023]

In a 24-week study involving 270 patients with mild cognitive impairment, donepezil did not show significant benefits in primary efficacy measures, indicating limited effectiveness in improving memory recall and overall cognitive change.

However, some secondary measures indicated that donepezil may improve attention, psychomotor speed, and patient-reported outcomes, suggesting potential benefits that warrant further investigation despite a higher incidence of mild to moderate adverse events in the treatment group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of donepezil in mild cognitive impairment: a randomized placebo-controlled trial. Salloway, S., Ferris, S., Kluger, A., et al.[2022]

In a study of 34 individuals with mild cognitive impairment, those taking a nutraceutical formulation (NF) showed significant improvement in cognitive function as measured by the Dementia Rating Scale (DRS) after 6 months, with an effect size greater than 0.7.

The placebo group did not show improvement during the initial 6 months but improved in DRS and stabilized in cognitive performance during a subsequent 6-month open-label extension when all participants received the NF, suggesting potential benefits of the nutraceutical even after initial placebo exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Nutritional Formulation for Cognitive Performance in Mild Cognitive Impairment: A Placebo-Controlled Trial with an Open-Label Extension. Remington, R., Lortie, JJ., Hoffmann, H., et al.[2016]

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]

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 of 237 patients with mild to moderate brain aging, CDP-choline (1000 mg/day) significantly improved cognitive and behavioral symptoms after two 21-day treatment cycles, with effects observed as early as the first cycle (p < 0.001).

The benefits of CDP-choline persisted during a one-week wash-out period, indicating lasting improvements in areas such as independence, social interactions, and attention, confirming its effectiveness as a treatment for brain aging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of CDP-choline on senile mental deterioration. Multicenter experience on 237 cases]. Serra, F., Diaspri, GP., Gasbarrini, 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]

Citations

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

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

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

Role of Citicoline in Patients With Mild Cognitive Impairment. [2023]

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

Efficacy of donepezil in mild cognitive impairment: a randomized placebo-controlled trial. [2022]

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

A Nutritional Formulation for Cognitive Performance in Mild Cognitive Impairment: A Placebo-Controlled Trial with an Open-Label Extension. [2016]

5. 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]

6. 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]

7. Italy pubmed.ncbi.nlm.nih.gov

[Effect of CDP-choline on senile mental deterioration. Multicenter experience on 237 cases]. [2013]

8. 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]