Clinical trial NCT05200208: Improving Sleep and Cognition in Alzheimer's Disease
Official title: Improving Sleep and Cognition in Alzheimer's Disease: A Pilot RCT of Citicoline
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Keywords: Sleep disturbance
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Goizueta Alzheimer's Disease Research Center (ADRC)
First posted: 2022-01-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in the impact on sleep by the administration of the citicoline supplement.
timeFrame: Baseline and 3 months
measure: Change in the impact on daytime sleepiness by the administration of the citicoline supplement.
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: To examine how a change in sleep correlates with changes in cognitive function with the administration of citicoline.
timeFrame: Baseline and 3 months
measure: To examine how a change in sleep correlates with changes in memory function with the administration of citicoline.
timeFrame: Baseline and 3 months
measure: To examine how a change in sleep correlates with changes in executive functioning with the administration of citicoline.
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University School of Nursing
state: Georgia
city: Atlanta
country: United States
facility: Goizueta Alzheimer's Disease Research Center
state: Georgia
Study officials:
affiliation: Emory School of Nursing, School of Public Health
name: Victoria Pak, PhD, MS, MTR
role: PRINCIPAL_INVESTIGATOR
References: