Impact of Citicoline on Sleep and Alzheimer's Biomarkers
Improving Sleep and Alzheimer's Disease (AD) Biomarkers: A Pilot Randomized Clinical Trial (RCT) of Citicoline
This study is testing whether a citicoline supplement can improve sleep quality and brain function in people with mild cognitive impairment and see how it affects Alzheimer's-related markers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Trial ID | NCT06029894 on ClinicalTrials.gov |
What this trial studies
This research investigates the effects of a dietary citicoline supplement on sleep quality and cognitive function in individuals with mild cognitive impairment (MCI). The study employs a randomized double-blind placebo-controlled design, recruiting participants from the Emory Alzheimer's Disease Research Center and the community. Researchers will assess cognitive decline and biomarkers associated with Alzheimer's disease, including Amyloid-Beta and tau proteins, to determine the supplement's efficacy. Participants will undergo interviews and may provide blood samples for biomarker analysis.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 60 and older with a diagnosis of mild cognitive impairment and sleep disturbances.
Not a fit: Patients with severe psychiatric disorders, certain chronic illnesses, or those currently taking medications affecting sleep may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance sleep quality and cognitive function in patients with mild cognitive impairment, potentially slowing the progression to Alzheimer's disease.
How similar studies have performed: Previous studies have shown that citicoline may positively impact cognitive decline, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 60 years or older * Diagnosis of Mild Cognitive Impairment (MCI) * Pittsburgh Sleep Quality Index total score \>5 or Epworth Sleepiness Scale score of ≥ 10 * Read and understand English * Have Internet and email access Exclusion Criteria: * No telephone access * Must not be taking any medication known to affect rapid eye movement (REM) sleep (or sleep architecture in general) * Use of choline supplements. * Epilepsy or head trauma resulting in unconsciousness in the past two years * Known allergic reactions to components of Citicoline * Presence of chronic obstructive pulmonary disease, asthma, severe cardiac insufficiency (congestive heart failure, myocardial infarction), type I diabetes, vitamin B12 or folic acid deficiency, liver cirrhosis, thyroid dysfunction, rheumatoid arthritis, chronic renal failure, severe/unstable psychiatric disorders, moderate to severe obstructive sleep apnea, restless legs syndrome or periodic limb movement disorder * History of alcohol dependence and drug abuse * Night shift workers or those in situations where they regularly experience jet lag or have irregular work schedules
Where this trial is running
Atlanta, Georgia and 1 other locations
- Emory University School of Nursing — Atlanta, Georgia, United States (Recruiting)
- Goizueta Alzheimer's Disease Research Center — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Victoria Pak, PhD, MS, MTR — Emory University
- Study coordinator: Victoria Pak, PhD, MS, MTR
- Email: victoria.m.pak@emory.edu
- Phone: 470-296-0081
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.