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Clinical Trial 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 in 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. Citicoline will be added to the standard of care treatment with donepezil.

Clinical Trial Description

The research team will test these hypotheses via a randomized, double-blind, placebo-controlled pilot study of citicoline in individuals with AD who are currently treated with donepezil. Participants will be recruited from the Alzheimer's Disease Research Center (ADRC) and from the community in the surrounding Atlanta area. Recruitment will be limited to those who have been prescribed donepezil as part of their clinical care. This will be a 3-month randomized, double-blind, placebo-controlled trial comparing citicoline+donepezil and placebo+donepezil 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 on donepezil at the maximum tolerated dosage (dose must be considered stable 3 months before screening confirmed by their physician) and aged 18 and over are eligible to participate. Eligible participants will be enrolled in a two-treatment trial comparing the effects of the standard of care donepezil and citicoline (1000 mg once per day with or without food) to the standard of care donepezil and placebo. The baseline (T0) visit will occur at the participant's annual ADRC visit and follow-up will occur 3 months later (T1) as a separate visit. For participants recruited from the community, the coordinator will arrange for an appropriate time for their baseline visit. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05200208
Study type Interventional
Source Emory University
Contact Victoria Pak, PhD, MS, MTR
Phone 470-296-0081
Email [email protected]
Status Recruiting
Phase N/A
Start date April 2022
Completion date June 2023

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