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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 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

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.

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,696 Previous Clinical Trials
2,603,721 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,782 Previous Clinical Trials
28,184,073 Total Patients Enrolled
Goizueta Alzheimer's Disease Research Center (ADRC)UNKNOWN

Media Library

Placebo (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05200208 — N/A
Alzheimer's Disease Research Study Groups: Citicoline Supplement, Placebo
Alzheimer's Disease Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05200208 — N/A
Placebo (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05200208 — N/A
~5 spots leftby Jul 2025