NCT05200208

Improving Sleep and Cognition in Alzheimer's Disease

Improving Sleep and Cognition in Alzheimer's Disease: A Pilot RCT of Citicoline

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The research team will test these hypotheses via a randomized, double-blind, placebo-controlled pilot study of citicoline in individuals with AD. Participants will be recruited from the Alzheimer's Disease Research Center (ADRC) and from the community in the surrounding Atlanta area. This will be a 3-month randomized, double-blind, placebo-controlled trial comparing citicoline and placebo in a well-characterized cohort of 20 individuals with AD. Subjective sleep measures will be measured via the Pittsburgh Sleep Quality Index (for measurement of sleep quality) and Epworth Sleepiness Scale (for measurement of sleepiness). For neuropsychological and cognition will be measured measures, the research team will employ the Rey Auditory Verbal Learning Test (RAVLT), Trail Making Test (TMT) Parts A \& B, and the Montreal Cognitive Assessment (MOCA). Those participating in the ADRC parent study or recruited from the community and diagnosed with AD in their medical record and aged 18 and over are eligible to participate. Eligible participants will be enrolled in a two-treatment trial comparing the effects of citicoline (1000 mg once per day with or without food) to a placebo. There will be a baseline (T0) visit and a follow-up 3 months later (T1) as a separate visit.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Citicoline supplement	Participants with AD will receive a dietary citicoline supplement. Subjective sleep measures will be measured via the Pittsburgh Sleep Quality Index (for measurement of sleep quality) and Epworth Sleepiness Scale (for measurement of sleepiness). Cognition will be measured by Rey Auditory Verbal Learning Test (RAVLT), Trail Making Test (TMT) Parts A \& B, and the Montreal Cognitive Assessment (MOCA). Participants will complete all questionnaires at baseline and at follow-up at 3 months.
OTHER	Placebo	Participants with AD will receive a placebo supplement. Subjective sleep measures will be measured via the Pittsburgh Sleep Quality Index (for measurement of sleep quality) and Epworth Sleepiness Scale (for measurement of sleepiness). Cognition will be measured by Rey Auditory Verbal Learning Test (RAVLT), Trail Making Test (TMT) Parts A \& B, and the Montreal Cognitive Assessment (MOCA). Participants will complete all questionnaires at baseline and at follow-up at 3 months.

Timeline

• Start date: 2022-07-27
• Primary completion: 2025-09-21
• Completion: 2025-09-21
• First posted: 2022-01-20
• Last updated: 2025-12-01

Locations

2 sites across 1 country: United States