NCT06029894Completed
Improving Sleep and AD Biomarkers
Improving Sleep and Alzheimer's Disease (AD) Biomarkers: A Pilot Randomized Clinical Trial (RCT) of Citicoline
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
The purpose of this research is to learn whether a dietary citicoline supplement will impact sleep and cognition. Cognitive disorders include such things as memory disorders and mild cognitive impairment. The investigators are studying persons with mild cognitive impairment (MCI). For this population, the team will assess whether citicoline also impacts biomarkers, a marker of the patient's biological state, in their body. The investigators are interested in learning more about a dietary supplement called citicoline and how it helps sleep, cognition, and markers of Alzheimer's. Previous studies have evaluated this dietary supplement and shown that citicoline may impact cognitive decline. The investigator would like to evaluate if citicoline will also impact sleep and markers of Alzheimer's. This dietary supplement has been assessed in older adults and found to be well tolerated. Citicoline has been used safely in cognitive impairment populations at the same dosage.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 10 Aug 2023
- Start date
- 15 Dec 2023
- Primary completion date
- 21 Dec 2025
- Lead sponsor
- Emory University
- Diseases
- Alzheimer disease
- NCT number
- NCT06029894
What you commit to
- Study type: Interventional
- Participants enrolled: 100
- From 15 Dec 2023 to the primary completion date, 21 Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Must not be taking any medication known to affect rapid eye movement (REM) sleep (or sleep architecture in general)
Other illness
- 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
Other
- No telephone access
- Use of choline supplements.
- Night shift workers or those in situations where they regularly experience jet lag or have irregular work schedules
Who the study is looking for
- 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
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Goizueta Alzheimer's Disease Research Center Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Emory University School of Nursing Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.