What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease, such as cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and memantine, have known side effects. Cholinesterase inhibitors can cause gastrointestinal issues (nausea, vomiting, diarrhea), muscle cramps, fatigue, and insomnia. Memantine may lead to dizziness, headache, confusion, and constipation. Citicoline, which is being studied for its potential cognitive and sleep benefits, is generally well-tolerated but may cause mild side effects like stomach pain, diarrhea, and insomnia.

What prior FDA approvals exist?

The FDA has approved several cholinesterase inhibitors for the treatment of Alzheimer's Disease, including donepezil, rivastigmine, and galantamine. These drugs work by increasing cholinergic transmission, which can provide modest symptomatic benefits in cognition and global functioning. Additionally, memantine, an NMDA receptor antagonist, is approved for moderate to severe Alzheimer's Disease and can be used in combination with cholinesterase inhibitors. These treatments aim to improve cognitive function, similar to the potential benefits of citicoline, which enhances phospholipid synthesis and neurotransmitter levels.

What other types of research exist?

Promising novel alternatives to Citicoline for Alzheimer's Disease patients include: <ol> <li>Cholinesterase inhibitors (donepezil, rivastigmine, galantamine) - These drugs increase cholinergic transmission and provide modest symptomatic benefits in cognition and global functioning.</li> <li></li> </ol> Memantine - An NMDA receptor antagonist that has shown efficacy in improving cognitive function in AD patients. 3. L-alpha-glyceryl-phosphorylcholine (alpha GPC) - Demonstrated significant improvements in neuropsychological parameters in patients with probable senile dementia of Alzheimer's type. 4. Antioxidants and folinic acid - Although results are mixed, some studies suggest potential benefits in cognitive function. 5. SSRIs (e.g., citalopram) - May improve psychotic and behavioral symptoms, which can indirectly benefit cognitive function and sleep.

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Citicoline Supplement for Alzheimer's Disease

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

At least 18 years of age living within the continental United States

Participants who are diagnosed with AD and confirmed from the medical record

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 Alzheimer's Disease sleep better and think more clearly. Citicoline may boost brain chemicals that are important for memory and sleep. Citicoline has been extensively used for the treatment of neurodegenerative disorders associated with head trauma, stroke, brain aging, cerebrovascular pathology, and Alzheimer's disease.

Who is the study for?

This trial is for adults with Alzheimer's Disease living in the continental U.S. who can read English and have internet access. It excludes those with severe health issues like heart failure, diabetes type I, liver cirrhosis; psychiatric disorders; sleep apnea; or a history of substance abuse.

What is being tested?

The study tests if a citicoline dietary supplement improves sleep and cognition in Alzheimer's patients compared to a placebo. Citicoline has shown promise in previous studies for cognitive decline and is considered well-tolerated.

What are the potential side effects?

Citicoline is generally well tolerated by individuals with Alzheimer's disease at the tested dosage. Specific side effects are not listed but may include mild gastrointestinal symptoms based on general knowledge of supplements.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 or older and live in the continental US.

Select...

I have been diagnosed with Alzheimer's disease, confirmed by my medical records.

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 the impact on daytime sleepiness by the administration of the citicoline supplement.

Change in the impact on sleep by the administration of the citicoline supplement.

Secondary study objectives

To examine how a change in sleep correlates with changes in cognitive function with the administration of citicoline.

To examine how a change in sleep correlates with changes in executive functioning with the administration of citicoline.

To examine how a change in sleep correlates with changes in memory function with the administration of citicoline.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Citicoline SupplementExperimental Treatment1 Intervention

Participants with AD will receive a dietary citicoline supplement

Group II: PlaceboPlacebo Group1 Intervention

Participants with AD will receive a placebo supplement

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Citicoline supplement

2018

N/A

~170

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 Alzheimer's Disease include cholinesterase inhibitors (donepezil, rivastigmine, and galantamine) and memantine. Cholinesterase inhibitors increase acetylcholine levels by inhibiting its breakdown, which helps improve memory and learning. Memantine regulates glutamate activity to prevent neuronal damage. Citicoline, which is being studied in combination with these treatments, enhances phospholipid synthesis and neurotransmitter levels, potentially improving cognitive function and sleep. These treatments are important as they aim to alleviate symptoms and improve the quality of life for AD patients.

An Overview of Combination Treatment with Citicoline in Dementia.The Citicholinage Study: Citicoline Plus Cholinesterase Inhibitors in Aged Patients Affected with Alzheimer's Disease Study.The cholinergic approach for the treatment of vascular dementia: evidence from pre-clinical and clinical studies.