What is the mechanism of action of this treatment?

Common treatments for Mild Cognitive Impairment (MCI) often focus on enhancing cognitive function, improving sleep, and impacting biomarkers associated with Alzheimer's disease. Citicoline, for example, works by increasing the levels of phosphatidylcholine, a key component of cell membranes, which supports neuronal repair and enhances neurotransmitter function. This is crucial for MCI patients as it can help slow cognitive decline, improve memory, and potentially delay the progression to Alzheimer's disease. Additionally, improving sleep quality can further support cognitive function and overall brain health, making these treatments particularly beneficial for MCI patients.

What side effects are associated with this type of intervention?

Common treatments for Mild Cognitive Impairment (MCI) include citicoline, acetylcholinesterase inhibitors (AChEIs), and memantine. Citicoline is generally well-tolerated with few side effects, but some individuals may experience gastrointestinal disturbances, headaches, or insomnia. AChEIs, such as donepezil, rivastigmine, and galantamine, can cause nausea, vomiting, diarrhea, muscle cramps, and loss of appetite. Memantine, used to treat moderate to severe Alzheimer's, may lead to dizziness, headache, confusion, and constipation. It is important to discuss these potential side effects with a healthcare provider to tailor the treatment plan to individual needs.

What prior FDA approvals exist?

Currently, there are no FDA-approved medications specifically for the treatment of Mild Cognitive Impairment (MCI). However, some treatments for Alzheimer's Disease, such as acetylcholinesterase inhibitors (e.g., donepezil, rivastigmine, and galantamine) and memantine, are sometimes used off-label to manage symptoms of MCI. These drugs aim to enhance cognitive function, similar to the potential benefits being studied with citicoline. Citicoline itself is not yet FDA-approved for MCI but is being investigated for its neuroprotective and cognitive-enhancing properties, as well as its potential to improve sleep and impact Alzheimer's biomarkers.

What other types of research exist?

Promising alternatives to citicoline for MCI patients include: 1) Memantine, which has been studied for its effects on cognitive function and Alzheimer's biomarkers. 2) SSRIs like citalopram, which may improve cognitive and behavioral symptoms. 3) Omega-3 fatty acids, although clinical trials have shown mixed results, they are still considered for their potential cognitive benefits. These alternatives should be discussed with a healthcare provider to tailor the best treatment plan.

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Citicoline Supplement for Mild Cognitive Impairment

N/A

Recruiting

Led By Victoria Pak, PhD, MS, MTR

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age: 60 years or older

Diagnosis of Mild Cognitive Impairment (MCI)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 3 months

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Citicoline is generally well-tolerated in older adults and has been used safely at similar doses in people with cognitive impairments. However, potential side effects were not explicitly listed; typically such supplements may cause digestive discomfort or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 60 years old or older.

Select...

I have been diagnosed with Mild Cognitive Impairment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in beta-amyloid 42 levels

Change in percentage of the rapid eye movement (REM) sleep

Change in plasma choline levels

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment GroupExperimental Treatment1 Intervention

Participants with MCI will receive dietary citicoline supplements.

Group II: PlaceboPlacebo Group1 Intervention

Participants with MCI will receive a placebo supplement.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Mild Cognitive Impairment (MCI) often focus on enhancing cognitive function, improving sleep, and impacting biomarkers associated with Alzheimer's disease. Citicoline, for example, works by increasing the levels of phosphatidylcholine, a key component of cell membranes, which supports neuronal repair and enhances neurotransmitter function. This is crucial for MCI patients as it can help slow cognitive decline, improve memory, and potentially delay the progression to Alzheimer's disease. Additionally, improving sleep quality can further support cognitive function and overall brain health, making these treatments particularly beneficial for MCI patients.