Improving Sleep and Cognition in Alzheimer's Disease

Completed · Not applicable · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

Cognitive disorders include such things as memory disorders, mild cognitive impairment, and Alzheimer's disease (AD). The purpose of the study is to learn more about whether a dietary citicoline supplement will improve sleep and cognition. Sleep disturbances currently afflict approximately 25-44% of those with AD, resulting in decreased quality of life for those with AD and their caregivers and are a major driver of institutionalization. Previous studies have tested this dietary supplement in Alzheimer's disease and shown that citicoline may improve cognitive decline. The research team would like to see if citicoline will also improve sleep. The citicoline that will be provided is made by Kyowa Hakko Pharma Chemical Company. This dietary supplement has been tested for Alzheimer's disease and found to be well tolerated. Citicoline has previously been used safely in other Alzheimer's disease populations at the same dosage.

Key facts

Study ID

NCT05200208

Run by

Emory University

People needed

20

Starts

2022-07-27

Expected to finish

2025-09-21

Last updated by the study team

2025-12-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants who are diagnosed with AD and confirmed from the medical record.
• At least 18 years of age living within the continental United States
• Read and understand English
• Have Internet and email access (this criterion applies to the legally authorized representatives)

You may not qualify if…

• No telephone access
• Epilepsy or head trauma resulting in unconsciousness in the past two years
• 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, and/or psychiatric disorders, obstructive sleep apnea, restless legs syndrome or periodic limb movement disorder
• History of alcohol dependence and medication abuse
• Night shift workers or those in situations where they regularly experience jet lag, or have irregular work schedules, since circadian misalignment may alter markers of inflammation

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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