Improving Sleep and AD Biomarkers

Completed · Not applicable · Has a placebo group

Conditions studied: Mild Cognitive Impairment, Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT06029894

Run by

Emory University

People needed

100

Starts

2023-12-15

Expected to finish

2025-12-21

Last updated by the study team

2026-02-27

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Emory University School of Nursing — Atlanta, Georgia, United States
• Goizueta Alzheimer's Disease Research Center — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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